Methods and compositions for treating psoriasis vulgaris

Abstract

This disclosure relates to a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof. This disclosure also relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the treatment of psoriasis vulgaris in a patient. This disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient. In some embodiments, the Disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment results in the patient maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a reduction of at least 2 points from baseline, or the patient maintaining at least a 50% reduction in the Psoriasis Area and Severity Index (PASI 50), or the patient maintaining at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), or the patient maintaining at least a 90% reduction in the Psoriasis Area and Severity Index (PASI 90), or the patient maintaining a 100% reduction in the Psoriasis Area and Severity Index (PASI 100), for at least about 60 weeks to at least about 432 weeks. In some embodiments, the disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment prevents the patient from experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks to at least about 432 weeks.

Description

[Technical Field]

[0001] Cross-references to related applications This application claims the interests of Indian Patent Application No. 202321036274, filed on 25 May 2023, the disclosures of which are incorporated herein by reference in their entirety.

[0002] Reference to electronic sequence listings This application has been filed electronically and includes an electronically submitted sequence listing. The sequence listing is titled "23-0711-WO_Sequence-Listing.xml", was created on 24 May 2024, and has a size of 11,332 bytes. The sequence listing contained in this .xml file is part of this Specified and is incorporated herein by reference in its entirety.

[0003] This disclosure relates to a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof. This disclosure also relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the treatment of psoriasis vulgaris in a patient. This disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient. In some embodiments, the Disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment results in the patient maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a reduction of at least 2 points from baseline, or the patient maintaining at least a 50% reduction in the Psoriasis Area and Severity Index (PASI 50), or the patient maintaining at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), or the patient maintaining at least a 90% reduction in the Psoriasis Area and Severity Index (PASI 90), or the patient maintaining a 100% reduction in the Psoriasis Area and Severity Index (PASI 100), for at least about 60 weeks to at least about 432 weeks. In some embodiments, the disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment prevents the patient from experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks to at least about 432 weeks. [Background technology]

[0004] Psoriasis is a chronic inflammatory skin disease affecting 2%–3% of the world's population. Psoriasis vulgaris is the most common form, affecting 80%–90% of patients. It is characterized by recurrent episodes of sharply defined, erythematous, scaly plaques of variable size and confluence. Psoriasis can manifest in a wide range of severity, with approximately 25% of patients suffering from moderate to severe chronic plaque psoriasis, which can be treated with topical medications, phototherapy, and / or systemic medications (conventional drugs and biological therapies). Biological therapies are also indicated for the treatment of patients with moderate to severe chronic plaque psoriasis, which are candidates for phototherapy or systemic therapy. Currently approved biological therapies include tumor necrosis factor antagonists, such as etanercept, infliximab, and adalimumab, as well as p40 (IL-12 and IL-23) antagonists, such as ustekinumab, guselkumab, and risankizumab, and IL-17 antagonists, such as secukinumab, ixekizumab, and brodalumab (Sbidian et al., “Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis,” Cochrane Database Syst. Rev. 12(12): CD011535 (2017); Ellis et al., Br. J. Dermatol. 180(2): 282-88 (2019)).

[0005] IL-23 is a heterodimeric cytokine consisting of a unique p19 subunit shared with IL-12 and a common p40 subunit. It is primarily produced by activated myeloid cells and signals through a heterodimeric IL-23 receptor complex consisting of a unique IL-23 receptor (IL23R) paired with IL-12Rβ1. Immediately after its discovery, IL-23 was recognized as a major driver of autoimmunity in mouse models and human diseases. This is generally attributed to IL-23's ability to polarize and activate Th17 cells, a subset of T cells identified as having a central role in autoimmunity. In recent years, accumulated data have implicated the IL-23 / Th17 pathway in the pathogenesis of psoriasis. Recent genome-wide association studies have identified psoriasis risk alleles around the gene regions encoding IL-23 (IL23A, IL12B) and the IL-23 receptor (IL-23R). In fact, both the p19 and p40 subunits of IL-23 are overexpressed in psoriatic skin lesions, while the intrinsic p35 subunit of IL-12 is not overexpressed.

[0006] Childra-kizumab (SCH 900222 / MK-3222), hereafter referred to as childra-kizumab (MK-3222), is a high-affinity (297 pM) humanized IgG1 / κ antibody that specifically binds to IL-23p19 (SN 08197) but does not bind to human IL-12 (IL-12p40 and p35 heterodimer) or human p40. The efficacy and safety of childra-kizumab in the treatment of patients with moderate to severe plaque psoriasis were demonstrated in two leading phase 3 trials (P010 and P011) (Beck et al., Psoriasis (Auckl.) 8:49-58 (2018); Reich et al., Lancet 390 (10091):276-88 (2017)). In summary, the resulting analysis demonstrated a positive change in the proportion of subjects with PASI 75, PASI 90, or PASI 100 responses, and in the proportion of subjects with PGA score “disappearance” or “minimum” with at least a two-grade reduction, when treated with tildrakizumab. The combined results from the two trials also showed that tildrakizumab is generally well-tolerated and associated with a low incidence of drug-related adverse events and adverse events leading to discontinuation of the study drug.

[0007] However, there remains a need for effective and safe long-term treatment options for psoriasis vulgaris. [Overview of the Initiative]

[0008] Provided herein is a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for a period of at least about 60 weeks to at least about 432 weeks.

[0009] Also provided herein is a method for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to patients for at least about 60 weeks to at least about 432 weeks.

[0010] Furthermore, provided herein is a method for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0011] Furthermore, provided herein is a method for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to patients for at least about 60 weeks to at least about 432 weeks.

[0012] Furthermore, provided herein is a method for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0013] Furthermore, provided herein is a method for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0014] Furthermore, provided herein is a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of hum13B8-b results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks to at least about 432 weeks compared to treatment for up to about 52 weeks.

[0015] Furthermore, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for a period of at least about 60 weeks to at least about 432 weeks.

[0016] Furthermore, the present invention provides a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0017] Furthermore, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0018] Furthermore, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0019] Furthermore, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 90% reduction (PASI 90) in psoriasis area and severity index in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0020] Furthermore, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0021] Furthermore, provided herein is a pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of the pharmaceutical composition results in a patient who does not experience an increase in adverse events (AE), drug-related AE, serious adverse events (SAE), Tier 1 AE, or Tier 2 AE over a treatment period of up to about 52 weeks, compared to a treatment period from at least about 60 weeks to at least about 432 weeks.

[0022] Furthermore, provided in the present invention is the use of anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the medicament is administered to the patient over a period from at least about 60 weeks to at least about 432 weeks.

[0023] Furthermore, provided in the present invention is the use of anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for maintaining a physician's global assessment (PGA) score of "clear" or "almost clear" with at least a 2-point decrease from baseline in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the medicament is administered to the patient over a period from at least about 60 weeks to at least about 432 weeks.

[0024] Furthermore, provided in the present invention is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for maintaining at least a 50% reduction (PASI 50) in the psoriasis area and severity index in patients with plaque psoriasis, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the medicament is administered to the patient over a period of at least about 60 weeks to at least about 432 weeks.

[0025] Furthermore, provided in the present invention is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for maintaining at least a 75% reduction (PASI 75) in the psoriasis area and severity index in patients with plaque psoriasis, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the medicament is administered to the patient over a period of at least about 60 weeks to at least about 432 weeks.

[0026] Furthermore, provided in the present invention is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for maintaining at least a 90% reduction (PASI 90) in the psoriasis area and severity index in patients with plaque psoriasis, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the medicament is administered to the patient over a period of at least about 60 weeks to at least about 432 weeks.

[0027] Furthermore, the present invention provides for the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0028] Furthermore, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in patients, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of the pharmaceutical product results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks to at least about 432 weeks compared to treatment up to about 52 weeks.

[0029] These and other features and advantages of this disclosure will be better understood from the following detailed description together with the attached claims. Note that the claims are defined by their enumeration and not by any specific consideration of the features and advantages set forth herein. [Brief explanation of the drawing]

[0030] The following detailed description of embodiments of this disclosure can be best understood when read in conjunction with the following drawings.

[0031] [Figure 1] Figure 1 is a schematic diagram showing the study design for the baseline and extension studies. Abbreviations: PASI = Psoriasis Area and Severity Index; NR = Non-responder; PR = Partial responder; R = Responder; D / C = Discontinued. [Figure 2] Figure 2 is a schematic diagram showing the test design for extensions 2 and 3. [Modes for carrying out the invention]

[0032] This disclosure relates to a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof. The invention also relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the treatment of psoriasis vulgaris in a patient. This disclosure further relates to the use of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient. In some embodiments, the Disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment results in the patient maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a reduction of at least 2 points from baseline, or the patient maintaining at least a 50% reduction in the Psoriasis Area and Severity Index (PASI 50), or the patient maintaining at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), or the patient maintaining at least a 90% reduction in the Psoriasis Area and Severity Index (PASI 90), or the patient maintaining a 100% reduction in the Psoriasis Area and Severity Index (PASI 100), for at least about 60 weeks to at least about 432 weeks. In some embodiments, the disclosure relates to methods, pharmaceutical compositions, and pharmaceuticals for treating psoriasis vulgaris, wherein the treatment prevents the patient from experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks to at least about 432 weeks.

[0033] Before describing this disclosure in detail, several terms are defined. Unless otherwise required by context, singular terms include plural forms and plural terms include singular forms. For example, the singular forms “a,” “an,” and “the” include plural references unless otherwise explicitly indicated by context. The terms “a” and “an” as used herein should be understood to mean “one or more” of the enumerated components unless otherwise indicated by context. The use of substitutes (e.g., “or”) should be understood to mean one, both, or any combination thereof of the substitutes unless otherwise indicated.

[0034] In this disclosure, any concentration range, percentage range, ratio range, or integer range should be understood to include any integer values ​​within the enumerated range, and, where appropriate, fractions thereof (e.g., one-tenth and one-hundredth of an integer), unless otherwise indicated.

[0035] The terms “about” or “approximately” mean an acceptable range of error for a particular value as determined by those skilled in the art, which in part depends on how the value is measured or determined, i.e., the limitations of the measurement system. For example, “about” can mean a standard deviation of three or more than three, according to practice in the art. Alternatively, “about” can mean a range of up to 20%, preferably up to 10%, more preferably up to 5%, and even more preferably up to 1% of a given value. Or, particularly with respect to biological systems or processes, the term can mean within an order of magnitude of a certain value, preferably up to five times, and more preferably up to two times. With respect to the administration of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment described herein, the term “about” means the number of weeks + / - 7 days when used in relation to the number of weeks.

[0036] Note that terms such as “preferably,” “generally,” and “typically” are not used herein to limit the scope of the claimed subject matter or to imply that certain features are significant, essential, or even more important to the structure or function of the claimed subject matter. Rather, these terms are merely intended to highlight alternative or additional features that may or may not be used in the particular embodiments of this disclosure.

[0037] For the purposes of describing and defining this disclosure, note that the term “substantially” is used herein to describe the degree of inherent uncertainty that may arise from any quantitative comparison, value, measurement, or other representation. The term “substantially” is also used herein to describe the extent to which a quantitative expression may deviate from the criteria described without resulting in a change in the fundamental function of the subject matter in question.

[0038] Unless explicitly specified otherwise, the term “including” is used in the context of this disclosure to indicate that additional components may exist in addition to the components of the list introduced by “including.” However, in certain embodiments of this disclosure, the term “including” is intended to encompass the possibility that no additional components exist.

[0039] As used in accordance with this disclosure, all technical and scientific terms, unless otherwise indicated, shall be understood to have the same meaning as that generally understood by those skilled in the art.

[0040] This disclosure relates to a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof. This disclosure also relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the treatment of psoriasis vulgaris in a patient. In one embodiment, provided herein is a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0041] In another embodiment, provided herein is a method for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear” in a patient with psoriasis vulgaris, with a decrease of at least 2 points from baseline, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0042] In another embodiment, provided herein is a method for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0043] In another embodiment, provided herein is a method for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0044] In another embodiment, provided herein is a method for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0045] In another embodiment, provided herein is a method for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in a patient with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to the patient in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0046] In another embodiment, provided herein is a method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of hum13B8-b results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for a period of at least about 60 weeks to at least about 432 weeks compared to treatment for up to about 52 weeks.

[0047] The present invention also relates to a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the treatment of psoriasis vulgaris in patients. In one embodiment, the present disclosure provides a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in patients, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0048] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear” in a patient with psoriasis vulgaris, with a decrease of at least 2 points from baseline, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0049] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0050] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0051] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0052] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0053] In another embodiment, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of the pharmaceutical composition results in a patient who does not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for a period of at least about 60 weeks to at least about 432 weeks compared to treatment for up to about 52 weeks.

[0054] The present invention also relates to the use of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient. In one embodiment, the present disclosure provides the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0055] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear” in patients with psoriasis vulgaris, with a decrease of at least 2 points from baseline, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0056] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0057] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in a patient with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0058] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0059] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical product is administered to the patient for at least about 60 weeks to at least about 432 weeks.

[0060] In another embodiment, provided herein is the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in patients, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administration of the pharmaceutical product results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for a period of at least about 60 weeks to at least about 432 weeks compared to treatment for up to about 52 weeks.

[0061] As used herein, the term "antibody" refers to a protein capable of recognizing and specifically binding to an antigen. Normal or conventional mammalian antibodies include tetramers, which typically consist of two identical pairs of polypeptide chains, with each pair consisting of one "light chain" (typically having a molecular weight of about 25 kDa) and one "heavy chain" (typically having a molecular weight of about 50 - 70 kDa). The terms "heavy chain" and "light chain," as used herein, refer to any immunoglobulin polypeptide having a variable domain sequence sufficient to confer specificity for a target antigen. The amino-terminal portions of each light chain and heavy chain typically contain a variable domain of about 100 - 110 or more amino acids involved in antigen recognition. The carboxyl-terminal portion of each chain typically defines a constant domain responsible for effector functions. Thus, in a native antibody, a full-length heavy chain immunoglobulin polypeptide contains a variable domain (V H ) and three constant domains (C H1 , C H2 , and C H3 ), as well as a hinge region between C H1 and C H2 , with the V H domain at the amino terminus of the polypeptide and the C H3 domain at the carboxyl terminus, and a full-length light chain immunoglobulin polypeptide contains a variable domain (V L ) and a constant domain (C L ), with the V L domain at the amino terminus of the polypeptide and the C L domain at the carboxyl terminus.

[0062] Within the full-length light and heavy chains, the variable and constant domains are typically linked by a "J" region of approximately 12 or more amino acids, while the heavy chain also contains a "D" region of approximately 10 additional amino acids. The variable region of each light / heavy chain pair typically forms the antigen-binding site. The variable domains of native antibodies typically exhibit the same general structure of a relatively conserved framework region (FR) linked by three hypervariable regions, also called complementarity-determining regions or CDRs. The CDRs from the two chains of each pair are typically aligned by the framework region, thereby enabling binding to specific epitopes. From the amino terminus to the carboxyl terminus, both the light and heavy chain variable domains typically contain domains FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4.

[0063] As used herein, the term “antigen-binding fragment” refers to a portion of an intact antibody and / or the antigen-determining variable domain of an intact antibody. It is known that the antigen-binding function of an antibody can be performed by fragments of a full-length antibody. Examples of antibody fragments include, but are not limited to, Fab, Fab', F(ab')2, and Fv fragments formed from antibody fragments, linear antibodies, single-chain antibodies, diabodies, and multispecific antibodies.

[0064] In certain embodiments, the anti-IL-23p19 antibody hum13B8-b is tildrakizumab. As used herein, the term “tildrakizumab” refers to the humanized anti-IL-23p19 monoclonal antibody, also known as SCH 900222 or MK-3222. Tildrakizumab is a high-affinity (297 picomoles [pM]) humanized immunoglobulin G1 / kappa (IgG1 / κ) antibody that specifically binds to the p19 protein of the IL-23 heterodimer, but does not bind to human IL-12 (IL-12 / 23p40 and IL-12p35 heterodimer) or human IL-12 / 23p40. Pharmacokinetics: The pharmacokinetics of tildrakizumab increase proportionally over a dose range of 50 mg to 200 mg (0.5 to 2 times the approved recommended dose) after subcutaneous administration in subjects with psoriasis vulgaris. Steady-state concentrations were achieved at week 0, week 4, and every 12 weeks thereafter, up to week 16 after subcutaneous administration of tildrakizumab. At the 100 mg dose at week 16, the mean (±SD) steady-state trough concentration ranged from 1.22±0.94 mcg / mL to 1.47±1.12 mcg / mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg / mL (34%). The absolute bioavailability of tildrakizumab was estimated to be 73-80% after subcutaneous injection. Peak concentration (Cmax) was reached by approximately 6 days.

[0065] In some embodiments, the anti-IL-23p19 antibody tildrakizumab may refer to ILUMYA®. ILUMYA® is administered by subcutaneous injection at a recommended dose of 100 mg at week 0, week 4, and every 12 weeks thereafter. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose pre-filled syringe containing 100 mg of tildrakizumab (i.e., 100 mg / mL). In some embodiments, ILUMYA® (tildrakizumab-asmn) injection for subcutaneous use is a sterile, clear to slightly milky, colorless to slightly yellowish solution. ILUMYA® is supplied in a single-dose pre-filled syringe with a glass barrel and a fixed 29-gauge 1 / 2-inch needle. In some embodiments, tildrakizumab can be formulated in water for injection with a pH of 5.7–6.3 in L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and / or sucrose. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose pre-filled syringe containing 100 mg of tildrakizumab-asmn, formulated in the following: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and water for injection USP with a pH of 5.7–6.3.

[0066] In certain embodiments, the anti-IL-23p19 antibody hum13B8-b (tildrakizumab) comprises a light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1 and a heavy chain polypeptide containing the amino acid sequence of SEQ ID NO: 2, which are disclosed in U.S. Patents No. 8,404,813 and No. 8,293,883, the respective disclosures of which are incorporated herein by reference in their entirety. In other embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment comprises a heavy chain variable domain and a light chain variable domain, the heavy chain variable domain comprising the CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 3-5, and the light chain variable domain comprising the CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 6-8.

[0067] Hum13B8-b light chain (SEQ ID NO: 1) DIQMTQSPSSLSASVGDRVTITCRTSENIYSYLAWYQQKPGKAPKLLIYNAKTLAEGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQHHYGIPFTFGQGTKVEIK RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

[0068] Hum13B8-b heavy chain (SEQ ID NO: 2) QVQLVQSGAEVKKPGASVKVSCKASGYIFITYWMTWVRQAPGQGLEWMGQIFPASGSADYNEKFEGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARGGGGFAYWGQGTL VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTH TCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKT ISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

[0069] Hum13B8-b heavy chain CDR1 (SEQ ID NO: 3) GYIFITYWMT

[0070] Hum13B8-b heavy chain CDR2 (SEQ ID NO: 4) QIFPASGSADYNEKFE

[0071] Hum13B8-b heavy chain CDR3 (SEQ ID NO: 5) GGGGFAY

[0072] Hum13B8-b light chain CDR1 (sequence number 6) RTSENIYSYLA

[0073] Hum13B8-b light chain CDR2 (sequence number 7) NAKTLAE

[0074] Hum13B8-b light chain CDR3 (Sequence ID 8) QHHYGIPFT

[0075] As used herein, the terms “subject” and “patient” are interchangeable. In some embodiments, the subject and / or patient are mammals.

[0076] "Disorder" is any condition that would benefit from treatment using the antibodies of this disclosure. "Disorder" and "condition" are used interchangeably herein and include chronic and acute disorders or diseases, including pathological conditions that make a patient susceptible to the disorder in question.

[0077] As used herein, the terms “treatment” or “to treat” refer to both therapeutic measures and preventive or preventive measures. Those in need of treatment include patients with psoriasis vulgaris, as well as those prone to developing psoriasis vulgaris or those who should be prevented from developing psoriasis vulgaris. In some embodiments, psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0078] As used herein, the terms “administer” or “to administer” refer to providing, contacting, and / or delivering an antibody or fragment thereof by any suitable route to achieve a desired effect. Administration may include, but is not limited to, oral, sublingual, parenteral (e.g., intravenous injection, subcutaneous injection, intradermal injection, intramuscular injection, intra-articular injection, intra-arterial injection, intra-synovial injection, intra-sternal injection, intrathecal injection, intrafocal injection, or intracranial injection), percutaneous, topical, buccal, rectal, vaginal, nasal, ophthalmic, inhalation, and implantation. In one embodiment, administration is subcutaneous via a pre-filled syringe (PFS).

[0079] In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug is administered subcutaneously to the patient. In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug is administered to the patient by subcutaneous injection. In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug is administered to the patient using an auto-injector or a pre-filled syringe.

[0080] In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the anti-IL-23p19 antibody hum13B8-b pharmaceutical composition, or the anti-IL-23p19 antibody hum13B8-b pharmaceutical is administered approximately every two weeks, every four weeks, every six weeks, every eight weeks, every ten weeks, or every twelve weeks.

[0081] As used herein, the term “Week 0” refers to the first day on which the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug is administered.

[0082] In some embodiments, the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the anti-IL-23p19 antibody hum13B8-b pharmaceutical composition, or the anti-IL-23p19 antibody hum13B8-b pharmaceutical is effective for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, and at least approximately 208 weeks. It is administered to the patient for a period of up to weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0083] The therapeutic dose or effective dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b pharmaceutical will vary in part depending on the patient's size (weight, body surface area, or organ size) and condition (age and overall health status). In some embodiments, the patient is administered one or more doses of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the dose being approximately 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, 160 mg, 180 mg, or 200 mg.

[0084] The term “therapeutic dose” as applied to dose or volume refers to the amount of a compound or pharmaceutical composition that is sufficient to produce the desired effect when administered to a patient who needs it. As used herein with respect to pharmaceutical compositions containing the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab), the term “therapeutic dose” also refers to the amount of a compound or pharmaceutical composition that is sufficient to produce an effective response when administered to a patient. In some embodiments, the therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) refers to doses of 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, 160 mg, 180 mg, or 200 mg. In some embodiments, the therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is a dose of 100 mg. In some embodiments, the effective therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is 100 mg at week 0 and every 12 weeks thereafter. In some embodiments, the effective therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is 100 mg at week 0, week 4, and every 12 weeks thereafter. In some embodiments, the effective therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is 200 mg at week 0 and every 12 weeks thereafter. In some embodiments, the effective therapeutic dose of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is 200 mg at week 0, week 4, and every 12 weeks thereafter.

[0085] In some embodiments, the initial dose and subsequent dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug are the same. In some embodiments, the initial dose and subsequent dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug are different. In some embodiments, the initial dose is 100 mg. In some embodiments, the initial dose is 200 mg. In some embodiments, the subsequent dose is 100 mg. In some embodiments, the subsequent dose is 200 mg. In some embodiments, the initial dose and subsequent dose are 100 mg. In some embodiments, the initial dose and subsequent dose are 200 mg. In some embodiments, the initial dose and subsequent doses include 100 mg of hum13B8-b. In some embodiments, the initial dose and subsequent doses include 200 mg of hum13B8-b.

[0086] In some embodiments, the initial dose, second dose, and subsequent dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b pharmaceutical are the same. In some embodiments, the initial dose, second dose, and subsequent dose of the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, the pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b pharmaceutical are different. In some embodiments, the initial dose is 100 mg. In some embodiments, the initial dose is 200 mg. In some embodiments, the second dose is 100 mg. In some embodiments, the second dose is 200 mg. In some embodiments, the subsequent dose is 100 mg. In some embodiments, the subsequent dose is 200 mg. In some embodiments, the initial dose, second dose, and subsequent dose are 100 mg. In some embodiments, the initial dose, second dose, and subsequent dose are 200 mg. In some embodiments, the initial dose, second dose, and subsequent dose contain 100 mg of hum13B8-b. In some embodiments, the initial dose, second dose, and subsequent dose contain 200 mg of hum13B8-b.

[0087] The Physician Global Assessment of Skin (PGA) is a useful clinician assessment of psoriatic lesions on the skin, based on the degree of erythema, thickness, and scaling averaged across the entire body. Each clinical sign is assessed on a scale of 0 to 5 (0=clear, 1=minimal, 2=mild, 3=moderate, and 4=severe). In some embodiments, a significant improvement in psoriasis vulgaris as assessed by the Physician Global Assessment of Skin may refer to subjects with a PGA score of "clear" or "nearly clear," which represents a decrease of at least 2 points from baseline.In some embodiments, significant improvement in psoriasis vulgaris, as assessed by a physician's overall assessment of the skin (whole body), is observed over a period of at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least This can refer to subjects who experience a "disappearance" or "near-disappearance" of the skin (whole body) PGA score, accompanied by a decrease of at least 2 points from baseline, for up to approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.In some embodiments, significant improvement in psoriasis vulgaris, as assessed by a physician's overall assessment of the skin (whole body), lasts for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. This can refer to subjects who exhibit a "disappearance" of the skin (whole body) PGA score, accompanied by a decrease of at least 2 points from baseline, for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0088] The Psoriasis Area and Severity Index (PASI) is used to determine the treatment response (PASI 50, PASI 75, PASI 90, and PASI 100) in subjects with psoriasis vulgaris. PASI includes scores for erythema, thickness, scaling, and the percentage of affected body surface area (BSA). In some embodiments, a significant improvement in psoriasis vulgaris as assessed by PASI may refer to subjects achieving at least a 50% improvement in the PASI score from baseline over at least approximately 60 weeks. In some embodiments, a significant improvement in psoriasis vulgaris as assessed by PASI may refer to subjects achieving at least a 75% improvement in the PASI score from baseline over at least approximately 60 weeks. In some embodiments, a significant improvement in psoriasis vulgaris as assessed by PASI may refer to subjects achieving at least a 90% improvement in the PASI score from baseline over at least approximately 60 weeks. In some embodiments, significant improvement in psoriasis vulgaris as assessed by PASI may refer to subjects achieving at least 100% improvement in PASI score from baseline over a period of at least approximately 60 weeks.In some embodiments, significant improvement in psoriasis vulgaris as assessed by PASI is observed over a period of at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 24 This can refer to subjects who achieve at least 50%, 75%, 90%, or 100% improvement in their PASI score from baseline over a period of up to 4 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0089] As used herein, the term “significant improvement” refers to a significant positive effect in response in patients taking the anti-IL-23p19 antibody hum13B8-b or its antigen-binding fragment, a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b, or the anti-IL-23p19 antibody hum13B8-b drug, compared to patients taking a placebo. In some embodiments, significant improvement in psoriasis vulgaris is assessed by the physician’s Generalized Assessment of Skin (PGA) or the Psoriasis Area and Severity Index (PASI). In certain embodiments, significant improvement refers to a statistically significant improvement. In certain embodiments, the term “statistically significant” means having a probability of less than 10% under the relevant null hypothesis (i.e., p < 0.1). In some embodiments, a p-value less than 0.05 is considered statistically significant. In some embodiments, a p-value less than 0.01 is considered statistically significant. In some embodiments, a p-value less than 0.005 is considered statistically significant. In some embodiments, a p-value less than 0.0025 is considered statistically significant. In some embodiments, a p-value less than 0.001 is considered statistically significant. In certain embodiments, the statistical test is two-sided at the 5% significance level, and the point estimate is accompanied by a two-sided 95% confidence interval (CI), where applicable.

[0090] In some embodiments, significant improvement may refer to an improvement of psoriasis vulgaris of at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 150%, or 200% or more, as assessed by the physician's overall assessment of skin (whole-body) or the Psoriasis Area and Severity Index (PTM).

[0091] In some embodiments, significant improvement may refer to an improvement of at least two, three, four, five, or ten times, or more than ten times, of psoriasis vulgaris, as assessed by the physician's overall assessment of skin (whole-body) (PGA) or the Psoriasis Area and Severity Index (PASI).

[0092] As used herein, the terms “pharmaceutical composition” or “therapeutic composition” refer to a compound or composition that, when appropriately administered to a patient, is capable of inducing a desired therapeutic effect. One embodiment of the present disclosure provides a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of at least one antibody of the present disclosure.

[0093] As used herein, the terms “pharmaceutically acceptable carrier” or “physiologically acceptable carrier” refer to one or more formulation materials suitable for achieving or enhancing the delivery of one or more antibodies of the present disclosure.

[0094] Pharmaceutical compositions comprising tildrakizumab, either alone or in combination with prophylactic agents, therapeutic agents, and / or pharmaceutically acceptable carriers, are provided. The tildrakizumab-containing pharmaceutical compositions provided herein, but not limited to, are intended for use in diagnosing, detecting, or monitoring disorders, in preventing, treating, managing, or improving one or more symptoms of a disorder, and / or for research use. Formulations of the pharmaceutical compositions, either alone or in combination with prophylactic agents, therapeutic agents, and / or pharmaceutically acceptable carriers, are known to those skilled in the art.

[0095] Embodiments: Embodiment 1: A method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and further, the method comprising administering hum13B8-b to the patient for at least about 60 weeks.

[0096] Embodiment 2: The method according to Embodiment 1, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0097] Embodiment 3: hum13B8-b lasts for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 2 The method according to Embodiment 1, administered to a patient for up to 44 weeks, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks.

[0098] Embodiment 4: The method according to Embodiment 1, wherein hum13B8-b is administered to the patient approximately every 12 weeks.

[0099] Embodiment 5: The method according to Embodiment 1, wherein hum13B8-b is administered subcutaneously to the patient.

[0100] Embodiment 6: The method according to Embodiment 5, wherein hum13B8-b is administered to the patient by subcutaneous injection.

[0101] Embodiment 7: The method according to Embodiment 6, wherein hum13B8-b is administered to the patient using an auto-injector or a pre-filled syringe.

[0102] Embodiment 8: The method according to Embodiment 1, wherein a therapeutically effective dose of hum13B8-b is administered to the patient.

[0103] Embodiment 9: The method according to Embodiment 1, wherein 100 mg or 200 mg of hum13B8-b is administered to the patient.

[0104] Embodiment 10: The method according to Embodiment 9, wherein 100 mg of hum13B8-b is administered to the patient.

[0105] Embodiment 11: The method according to Embodiment 9, wherein 200 mg of hum13B8-b is administered to the patient.

[0106] Embodiment 12: The method according to Embodiment 1, wherein an initial dose of hum13B8-b is administered to the patient in week 0, and subsequent doses of hum13B8-b are administered to the patient approximately every 12 weeks thereafter.

[0107] Embodiment 13: The method according to Embodiment 12, wherein the initial dose and subsequent doses are the same.

[0108] Embodiment 14: The method according to Embodiment 12, wherein the initial dose and subsequent doses are different.

[0109] Embodiment 15: The method according to Embodiment 12, wherein the initial dose is 100 mg.

[0110] Embodiment 16: The method according to Embodiment 12, wherein the initial dose is 200 mg.

[0111] Embodiment 17: The method according to Embodiment 12, wherein the subsequent dose is 100 mg.

[0112] Embodiment 18: The method according to Embodiment 12, wherein the subsequent dose is 200 mg.

[0113] Embodiment 19: The method according to Embodiment 13, wherein the initial dose and subsequent dose are 100 mg.

[0114] Embodiment 20: The method according to Embodiment 13, wherein the initial dose and subsequent dose are 200 mg.

[0115] Embodiment 21: The method according to Embodiment 14, wherein the initial dose is 100 mg and the subsequent dose is 200 mg.

[0116] Embodiment 22: The method according to Embodiment 14, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

[0117] Embodiment 23: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 12, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0118] Embodiment 24: The method according to Embodiment 1, wherein the first dose of hum13B8-b is administered to the patient in week 0, the second dose of hum13B8-b is administered to the patient in approximately week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter.

[0119] Embodiment 25: The method according to Embodiment 24, wherein the initial dose, the second dose, and the subsequent dose are the same.

[0120] Embodiment 26: The method according to Embodiment 25, wherein the initial dose, the second dose, and the subsequent dose are 100 mg.

[0121] Embodiment 27: The method according to Embodiment 25, wherein the initial dose, the second dose, and the subsequent dose are 200 mg.

[0122] Embodiment 28: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 24, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0123] Embodiment 29: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 60 weeks.

[0124] Embodiment 30: Administration of hum13B8-b provides at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least approximately 256 weeks. The method according to Embodiment 29, which results in a patient maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0125] Embodiment 31: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 60 weeks.

[0126] Embodiment 32: Administration of hum13B8-b provides at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to Embodiment 31, which results in a patient maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0127] Embodiment 33: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for at least approximately 60 weeks.

[0128] Embodiment 34: Administration of hum13B8-b provides at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to Embodiment 33, which results in a patient maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0129] Embodiment 35: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for at least approximately 60 weeks.

[0130] Embodiment 36: Administration of hum13B8-b provides at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to Embodiment 35, which results in a patient maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0131] Embodiment 37: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 60 weeks.

[0132] Embodiment 38: Administration of hum13B8-b results in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 24 The method according to Embodiment 37, which results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for up to 4 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0133] Embodiment 39: The method according to Embodiment 1, wherein administration of hum13B8-b results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 60 weeks compared to treatment for up to approximately 52 weeks.

[0134] Embodiment 40: Administration of hum13B8-b resulted in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to Embodiment 39, which results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment lasting up to approximately 52 weeks, for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0135] Embodiment 41: A method for maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least approximately 60 weeks.

[0136] Embodiment 42: A method for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administering hum13B8-b to patients for at least about 60 weeks.

[0137] Embodiment 43: A method for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administering hum13B8-b to patients for at least about 60 weeks.

[0138] Embodiment 44: A method for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and administering hum13B8-b to patients for at least about 60 weeks.

[0139] Embodiment 45: A method for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and hum13B8-b is administered to the patient for at least about 60 weeks.

[0140] Embodiment 46: The method according to any one of embodiments 41 to 45, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0141] Embodiment 47: hum13B8-b lasts for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to any one of Embodiments 41 to 45, administered to the patient for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0142] Embodiment 48: The method according to any one of embodiments 41 to 45, wherein hum13B8-b is administered to the patient approximately every 12 weeks.

[0143] Embodiment 49: The method according to any one of embodiments 41 to 45, wherein hum13B8-b is administered subcutaneously to the patient.

[0144] Embodiment 50: The method according to Embodiment 49, wherein hum13B8-b is administered to the patient by subcutaneous injection.

[0145] Embodiment 51: The method according to Embodiment 50, wherein hum13B8-b is administered to the patient using an auto-injector or a pre-filled syringe.

[0146] Embodiment 52: The method according to any one of embodiments 41 to 45, wherein a therapeutically effective dose of hum13B8-b is administered to the patient.

[0147] Embodiment 53: The method according to any one of embodiments 41 to 45, wherein 100 mg or 200 mg of hum13B8-b is administered to the patient.

[0148] Embodiment 54: The method according to Embodiment 53, wherein 100 mg of hum13B8-b is administered to the patient.

[0149] Embodiment 55: The method according to Embodiment 53, wherein 200 mg of hum13B8-b is administered to the patient.

[0150] Embodiment 56: The method according to any one of embodiments 41 to 45, wherein an initial dose of hum13B8-b is administered to the patient in week 0, and subsequent doses of hum13B8-b are administered to the patient approximately every 12 weeks thereafter.

[0151] Embodiment 57: The method according to embodiment 56, wherein the initial dose and subsequent doses are the same.

[0152] Embodiment 58: The method according to embodiment 56, wherein the initial dose and subsequent doses are different.

[0153] Embodiment 59: The method according to Embodiment 56, wherein the initial dose is 100 mg.

[0154] Embodiment 60: The method according to Embodiment 56, wherein the initial dose is 200 mg.

[0155] Embodiment 61: The method according to Embodiment 56, wherein the subsequent dose is 100 mg.

[0156] Embodiment 62: The method according to Embodiment 56, wherein the subsequent dose is 200 mg.

[0157] Embodiment 63: The method according to Embodiment 57, wherein the initial dose and subsequent dose are 100 mg.

[0158] Embodiment 64: The method according to Embodiment 57, wherein the initial dose and subsequent dose are 200 mg.

[0159] Embodiment 65: The method according to Embodiment 58, wherein the initial dose is 100 mg and the subsequent dose is 200 mg.

[0160] Embodiment 66: The method according to Embodiment 58, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

[0161] Embodiment 67: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 56, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0162] Embodiment 68: The method according to any one of embodiments 41 to 45, wherein the first dose of hum13B8-b is administered to the patient in week 0, the second dose of hum13B8-b is administered to the patient in approximately week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter.

[0163] Embodiment 69: The method according to Embodiment 68, wherein the initial dose, the second dose, and the subsequent dose are the same.

[0164] Embodiment 70: The method according to Embodiment 69, wherein the initial dose, the second dose, and the subsequent dose are 100 mg.

[0165] Embodiment 71: The method according to Embodiment 69, wherein the initial dose, second dose, and subsequent dose are 200 mg.

[0166] Embodiment 72: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 68, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0167] Embodiment 73: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0168] Embodiment 74: The pharmaceutical composition according to Embodiment 73, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0169] Embodiment 75: The pharmaceutical composition will last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The pharmaceutical composition according to either Embodiment 73 or Embodiment 74, which is administered to a patient for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0170] Embodiment 76: A pharmaceutical composition according to any one of embodiments 73 to 75, wherein the pharmaceutical composition is administered to a patient approximately every 12 weeks.

[0171] Embodiment 77: A pharmaceutical composition according to any one of embodiments 73 to 76, wherein the pharmaceutical composition is administered subcutaneously to a patient.

[0172] Embodiment 78: A pharmaceutical composition according to any one of embodiments 73 to 77, wherein the pharmaceutical composition is administered to a patient by subcutaneous injection.

[0173] Embodiment 79: A pharmaceutical composition according to any one of embodiments 73 to 78, wherein the pharmaceutical composition is administered to a patient using an auto-injector or a pre-filled syringe.

[0174] Embodiment 80: A pharmaceutical composition according to any one of embodiments 73 to 79, wherein a therapeutically effective amount of the pharmaceutical composition is administered to a patient.

[0175] Embodiment 81: A pharmaceutical composition according to any one of embodiments 73 to 80, wherein the dosage of the pharmaceutical composition contains 100 mg or 200 mg of hum13B8-b.

[0176] Embodiment 82: The pharmaceutical composition according to Embodiment 81, wherein the dosage of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0177] Embodiment 83: The pharmaceutical composition according to Embodiment 81, wherein the dosage of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0178] Embodiment 84: A pharmaceutical composition according to any one of embodiments 73 to 83, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

[0179] Embodiment 85: The pharmaceutical composition according to Embodiment 84, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are the same.

[0180] Embodiment 86: The pharmaceutical composition according to Embodiment 84, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are different.

[0181] Embodiment 87: The pharmaceutical composition according to Embodiment 84, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0182] Embodiment 88: The pharmaceutical composition according to Embodiment 84, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0183] Embodiment 89: The pharmaceutical composition according to Embodiment 84, wherein the subsequent dose pharmaceutical composition contains 100 mg of hum13B8-b.

[0184] Embodiment 90: The pharmaceutical composition according to Embodiment 84, wherein the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0185] Embodiment 91: The pharmaceutical composition according to Embodiment 85, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 100 mg of hum13B8-b.

[0186] Embodiment 92: The pharmaceutical composition according to Embodiment 85, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0187] Embodiment 93: The pharmaceutical composition according to Embodiment 86, wherein the initial dose pharmaceutical composition contains 100 mg of hum13B8-b, and the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0188] Embodiment 94: The pharmaceutical composition according to Embodiment 86, wherein the initial dose pharmaceutical composition contains 200 mg of hum13B8-b, and the subsequent dose pharmaceutical composition contains 100 mg of hum13B8-b.

[0189] Embodiment 95: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 84, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0190] Embodiment 96: A pharmaceutical composition according to any one of embodiments 73 to 83, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in approximately week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

[0191] Embodiment 97: The pharmaceutical composition according to Embodiment 96, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition are the same.

[0192] Embodiment 98: The pharmaceutical composition according to Embodiment 97, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 100 mg of humB138-b.

[0193] Embodiment 99: The pharmaceutical composition according to Embodiment 97, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0194] Embodiment 100: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 96, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0195] Embodiment 101: A pharmaceutical composition according to any one of embodiments 73 to 100, which, upon administration of the pharmaceutical composition, results in a patient maintaining a physician's overall assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least about 60 weeks.

[0196] Embodiment 102: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, at least approximately 256 weeks, and at least approximately 2 A pharmaceutical composition according to any one of Embodiments 73 to 101, which results in a patient maintaining a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for up to 68 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0197] Embodiment 103: A pharmaceutical composition according to any one of embodiments 73 to 102, which, upon administration of the pharmaceutical composition, results in a patient maintaining at least a 50% reduction (PASI 50) in psoriasis area and severity index for at least about 60 weeks.

[0198] Embodiment 104: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks A pharmaceutical composition according to any one of Embodiments 73 to 103, which results in a patient maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0199] Embodiment 105: A pharmaceutical composition according to any one of embodiments 73 to 102, which, upon administration of the pharmaceutical composition, results in a patient maintaining at least a 75% reduction (PASI 75) in psoriasis area and severity index for at least about 60 weeks.

[0200] Embodiment 106: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks A pharmaceutical composition according to any one of embodiments 73 to 102 or 105, which results in a patient maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0201] Embodiment 107: A pharmaceutical composition according to any one of embodiments 73 to 102, which, upon administration of the pharmaceutical composition, results in a patient maintaining at least a 90% reduction (PASI 90) in psoriasis area and severity index for at least about 60 weeks.

[0202] Embodiment 108: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks A pharmaceutical composition according to any one of Embodiments 73-102 or 107, which results in a patient maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0203] Embodiment 109: A pharmaceutical composition according to any one of embodiments 73 to 102, which, upon administration of the pharmaceutical composition, results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least about 60 weeks.

[0204] Embodiment 110: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. A pharmaceutical composition according to any one of Embodiments 73 to 102 or 109, which results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0205] Embodiment 111: A pharmaceutical composition according to any one of embodiments 73 to 110, which, upon administration of the pharmaceutical composition, results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks compared to treatment for up to about 52 weeks.

[0206] Embodiment 112: By administering the pharmaceutical composition, the effects last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least A pharmaceutical composition according to any one of Embodiments 73 to 111, which results in a patient who does not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment for up to approximately 52 weeks, for up to approximately 256 weeks, for at least approximately 268 weeks, for at least approximately 280 weeks, for at least approximately 292 weeks, for at least approximately 304 weeks, for at least approximately 316 weeks, for at least approximately 328 weeks, for at least approximately 340 weeks, for at least approximately 352 weeks, for at least approximately 364 weeks, for at least approximately 384 weeks, for at least approximately 396 weeks, for at least approximately 408 weeks, or for at least approximately 432 weeks.

[0207] Embodiment 113: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0208] Embodiment 114: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0209] Embodiment 115: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0210] Embodiment 116: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0211] Embodiment 117: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition is administered to the patient for at least about 60 weeks.

[0212] Embodiment 118: A pharmaceutical composition according to any one of embodiments 113 to 117, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0213] Embodiment 119: The pharmaceutical composition will last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. A pharmaceutical composition according to any one of Embodiments 113 to 118, administered to a patient for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0214] Embodiment 120: A pharmaceutical composition according to any one of embodiments 113 to 119, wherein the pharmaceutical composition is administered to a patient approximately every 12 weeks.

[0215] Embodiment 121: A pharmaceutical composition according to any one of embodiments 113 to 120, wherein the pharmaceutical composition is administered subcutaneously to a patient.

[0216] Embodiment 122: A pharmaceutical composition according to any one of embodiments 113 to 121, wherein the pharmaceutical composition is administered to a patient by subcutaneous injection.

[0217] Embodiment 123: A pharmaceutical composition according to any one of embodiments 113 to 122, wherein the pharmaceutical composition is administered to a patient using an auto-injector or a pre-filled syringe.

[0218] Embodiment 124: A pharmaceutical composition according to any one of embodiments 113 to 123, wherein a therapeutically effective amount of the pharmaceutical composition is administered to a patient.

[0219] Embodiment 125: A pharmaceutical composition according to any one of Embodiments 113 to 124, wherein the dosage of the pharmaceutical composition contains 100 mg or 200 mg of hum13B8-b.

[0220] Embodiment 126: The pharmaceutical composition according to Embodiment 125, wherein the dosage of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0221] Embodiment 127: The pharmaceutical composition according to Embodiment 125, wherein the dosage of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0222] Embodiment 128: A pharmaceutical composition according to any one of embodiments 113 to 127, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

[0223] Embodiment 129: The pharmaceutical composition according to Embodiment 128, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are the same.

[0224] Embodiment 130: The pharmaceutical composition according to Embodiment 128, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are different.

[0225] Embodiment 131: The pharmaceutical composition according to Embodiment 128, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0226] Embodiment 132: The pharmaceutical composition according to Embodiment 128, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0227] Embodiment 133: The pharmaceutical composition according to Embodiment 128, wherein the subsequent dose pharmaceutical composition contains 100 mg of hum13B8-b.

[0228] Embodiment 134: The pharmaceutical composition according to Embodiment 128, wherein the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0229] Embodiment 135: The pharmaceutical composition according to Embodiment 129, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 100 mg of hum13B8-b.

[0230] Embodiment 136: The pharmaceutical composition according to Embodiment 129, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0231] Embodiment 137: The pharmaceutical composition according to Embodiment 130, wherein the initial dose pharmaceutical composition contains 100 mg of hum13B8-b, and the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0232] Embodiment 138: The pharmaceutical composition according to Embodiment 130, wherein the initial dose pharmaceutical composition contains 200 mg of hum13B8-b, and the subsequent dose pharmaceutical composition contains 100 mg of hum13B8-b.

[0233] Embodiment 139: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 128, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0234] Embodiment 140: A pharmaceutical composition according to any one of embodiments 113 to 127, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in approximately week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

[0235] Embodiment 141: The pharmaceutical composition according to Embodiment 140, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition are the same.

[0236] Embodiment 142: The pharmaceutical composition according to Embodiment 141, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 100 mg of hum13B8-b.

[0237] Embodiment 143: The pharmaceutical composition according to Embodiment 141, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0238] Embodiment 144: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 140, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0239] Embodiment 145: Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and wherein the medicament is administered to the patient over at least about 60 weeks.

[0240] Embodiment 146: The use according to embodiment 145, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0241] Embodiment 147: The use according to embodiment 145, wherein the medicament is administered to the patient over at least about 64 weeks, at least about 76 weeks, at least about 88 weeks, at least about 100 weeks, at least about 112 weeks, at least about 124 weeks, at least about 136 weeks, at least about 148 weeks, at least about 160 weeks, at least about 172 weeks, at least about 184 weeks, at least about 196 weeks, at least about 208 weeks, at least about 220 weeks, at least about 232 weeks, at least about 244 weeks, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks.

[0242] Embodiment 148: The use according to embodiment 145, wherein the medicament is administered to the patient every about 12 weeks.

[0243] Embodiment 149: The use described in Embodiment 145, wherein the drug is administered subcutaneously to the patient.

[0244] Embodiment 150: The use described in Embodiment 149, wherein the drug is administered to the patient by subcutaneous injection.

[0245] Embodiment 151: The use according to Embodiment 150, wherein the pharmaceutical product is administered to the patient using a self-injector or a pre-filled syringe.

[0246] Embodiment 152: The use according to Embodiment 145, wherein a therapeutically effective amount of the drug is administered to the patient.

[0247] Embodiment 153: The use according to Embodiment 145, wherein the dosage of the drug contains 100 mg or 200 mg of hum13B8-b.

[0248] Embodiment 154: The use according to Embodiment 153, wherein the dosage of the drug contains 100 mg of hum13B8-b.

[0249] Embodiment 155: The use according to Embodiment 153, wherein the dosage of the drug contains 200 mg of hum13B8-b.

[0250] Embodiment 156: The use according to Embodiment 145, wherein the initial dose of the drug is administered to the patient in week 0, and subsequent doses of the drug are administered to the patient approximately every 12 weeks thereafter.

[0251] Embodiment 157: The use described in Embodiment 156, wherein the initial dose of the drug and the subsequent dose of the drug are the same.

[0252] Embodiment 158: The use described in Embodiment 156, wherein the initial dose of the drug and the subsequent dose of the drug are different.

[0253] Embodiment 159: The use according to embodiment 156, wherein the pharmaceutical product for the initial dose contains 100 mg of hum13B8-b.

[0254] Embodiment 160: The use according to embodiment 156, wherein the pharmaceutical product for the initial dose contains 200 mg of hum13B8-b.

[0255] Embodiment 161: The use according to embodiment 156, wherein the pharmaceutical product for subsequent doses contains 100 mg of hum13B8-b.

[0256] Embodiment 162: The use according to embodiment 156, wherein the pharmaceutical product for subsequent doses contains 200 mg of hum13B8-b.

[0257] Embodiment 163: The use according to embodiment 157, wherein the pharmaceutical product for the initial dose and the pharmaceutical product for subsequent doses contain 100 mg of hum13B8-b.

[0258] Embodiment 164: The use according to embodiment 157, wherein the pharmaceutical product for the initial dose and the pharmaceutical product for subsequent doses contain 200 mg of hum13B8-b.

[0259] Embodiment 165: The use according to embodiment 158, wherein the pharmaceutical product for the initial dose contains 100 mg of hum13B8-b and the pharmaceutical product for subsequent doses contains 200 mg of hum13B8-b.

[0260] Embodiment 166: The use according to embodiment 158, wherein the pharmaceutical product for the initial dose contains 200 mg of hum13B8-b and the pharmaceutical product for subsequent doses contains 100 mg of hum13B8-b.

[0261] Embodiment 167: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 156, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0262] Embodiment 168: The use according to Embodiment 145, wherein the initial dose of the drug is administered to the patient in week 0, the second dose of the drug is administered to the patient in approximately week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0263] Embodiment 169: The use described in Embodiment 168, wherein the initial dose, the second dose, and the subsequent doses of the drug are the same.

[0264] Embodiment 170: The use according to Embodiment 169, wherein the initial dose, the second dose, and the subsequent dose each contain 100 mg of humB138-b.

[0265] Embodiment 171: The use according to Embodiment 169, wherein the initial dose, the second dose, and the subsequent dose each contain 200 mg of hum13B8-b.

[0266] Embodiment 172: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 168, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0267] Embodiment 173: The use according to Embodiment 145, wherein the administration of the drug results in a patient maintaining a physician's overall assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 60 weeks.

[0268] Embodiment 174: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, for at least approximately 244 weeks, for at least approximately 256 weeks, The use according to Embodiment 173 results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0269] Embodiment 175: The use according to Embodiment 145, which results in patients maintaining at least a 50% reduction (PASI 50) in psoriasis area and severity index for at least approximately 60 weeks through the administration of the drug.

[0270] Embodiment 176: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and for at least approximately 244 weeks The use according to Embodiment 175 results in a patient maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0271] Embodiment 177: The use according to Embodiment 145, which results in patients maintaining at least a 75% reduction (PASI 75) in psoriasis area and severity index for at least approximately 60 weeks through the administration of the drug.

[0272] Embodiment 178: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and for at least approximately 244 weeks The use according to Embodiment 177 results in a patient maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0273] Embodiment 179: The use according to Embodiment 145, which results in patients maintaining at least a 90% reduction (PASI 90) in psoriasis area and severity index for at least approximately 60 weeks through the administration of the drug.

[0274] Embodiment 180: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and for at least approximately 244 weeks The use according to Embodiment 179 results in a patient maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0275] Embodiment 181: The use according to Embodiment 145, which results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 60 weeks through the administration of the drug.

[0276] Embodiment 182: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and for at least approximately 244 weeks The use according to Embodiment 181 results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0277] Embodiment 183: The use according to Embodiment 145, which results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 60 weeks compared to treatment for approximately 52 weeks.

[0278] Embodiment 184: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, for at least approximately 244 weeks, at least The use according to Embodiment 183 results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment lasting up to approximately 52 weeks, for up to approximately 256 weeks, at least for up to approximately 268 weeks, at least for up to approximately 280 weeks, at least for up to approximately 292 weeks, at least for up to approximately 304 weeks, at least for up to approximately 316 weeks, at least for up to approximately 328 weeks, at least for up to approximately 340 weeks, at least for up to approximately 352 weeks, at least for up to approximately 364 weeks, at least for up to approximately 384 weeks, at least for up to approximately 396 weeks, at least for up to approximately 408 weeks, or at least for up to approximately 432 weeks.

[0279] Embodiment 185: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug to maintain a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the drug is administered to the patient for at least about 60 weeks.

[0280] Embodiment 186: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the drug is administered to the patient for at least about 60 weeks.

[0281] Embodiment 187: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug to maintain at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the drug is administered to the patient for at least about 60 weeks.

[0282] Embodiment 188: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the drug is administered to the patient for at least about 60 weeks.

[0283] Embodiment 189: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a drug for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and the drug is administered to the patient for at least about 60 weeks.

[0284] Embodiment 190: The use according to any one of embodiments 185 to 189, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0285] Embodiment 191: The drug will last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The use according to any one of Embodiments 185 to 189, administered to the patient for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0286] Embodiment 192: The use described in any one of Embodiments 185 to 189, wherein the drug is administered to the patient approximately every 12 weeks.

[0287] Embodiment 193: The use described in any one of Embodiments 185 to 189, wherein the drug is administered subcutaneously to the patient.

[0288] Embodiment 194: The use described in Embodiment 193, wherein the drug is administered to the patient by subcutaneous injection.

[0289] Embodiment 195: The use according to Embodiment 194, wherein the drug is administered to the patient using a self-injector or a pre-filled syringe.

[0290] Embodiment 196: The use according to any one of Embodiments 185 to 189, wherein a therapeutically effective amount of the drug is administered to the patient.

[0291] Embodiment 197: The use according to any one of Embodiments 185 to 189, wherein the dosage of the drug contains 100 mg or 200 mg of hum13B8-b.

[0292] Embodiment 198: The use described in Embodiment 197, wherein the dosage of the drug contains 100 mg of hum13B8-b.

[0293] Embodiment 199: The use according to Embodiment 197, wherein the dosage of the drug contains 200 mg of hum13B8-b.

[0294] Embodiment 200: The use according to any one of embodiments 185 to 189, wherein the initial dose of the drug is administered to the patient in week 0, and subsequent doses of the drug are administered to the patient approximately every 12 weeks thereafter.

[0295] Embodiment 201: The use described in Embodiment 200, wherein the initial dose of the drug and the subsequent dose of the drug are the same.

[0296] Embodiment 202: The use described in Embodiment 200, wherein the initial dose of the drug and the subsequent dose of the drug are different.

[0297] Embodiment 203: The use described in Embodiment 200, wherein the initial dose of the drug contains 100 mg of hum13B8-b.

[0298] Embodiment 204: The use according to Embodiment 200, wherein the initial dose of the drug contains 200 mg of hum13B8-b.

[0299] Embodiment 205: The use according to Embodiment 200, wherein the subsequent dose of the drug contains 100 mg of hum13B8-b.

[0300] Embodiment 206: The use according to Embodiment 200, wherein the subsequent dose of the drug contains 200 mg of hum13B8-b.

[0301] Embodiment 207: The use according to Embodiment 201, wherein the initial dose and subsequent doses of the drug each contain 100 mg of hum13B8-b.

[0302] Embodiment 208: The use according to Embodiment 201, wherein the initial dose and subsequent doses of the drug each contain 200 mg of hum13B8-b.

[0303] Embodiment 209: The use according to Embodiment 202, wherein the initial dose of the drug contains 100 mg of hum13B8-b, and the subsequent dose of the drug contains 200 mg of hum13B8-b.

[0304] Embodiment 210: The use according to Embodiment 202, wherein the initial dose of the drug contains 200 mg of hum13B8-b, and the subsequent dose of the drug contains 100 mg of hum13B8-b.

[0305] Embodiment 211: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 200, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0306] Embodiment 212: The use according to any one of Embodiments 185 to 189, wherein the initial dose of the drug is administered to the patient in week 0, the second dose of the drug is administered to the patient in approximately week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0307] Embodiment 213: The use described in Embodiment 212, wherein the initial dose, the second dose, and the subsequent doses of the drug are the same.

[0308] Embodiment 214: The use according to Embodiment 213, wherein the initial dose, the second dose, and the subsequent dose each contain 100 mg of hum13B8-b.

[0309] Embodiment 215: The use according to Embodiment 213, wherein the initial dose, the second dose, and the subsequent dose each contain 200 mg of hum13B8-b.

[0310] Embodiment 216: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 212, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0311] Embodiment 217: A method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; hum13B8-b is administered to the patient for at least approximately 60 weeks; and the patient has a reduced risk of cardiac adverse events for at least approximately 60 weeks compared to the risk of cardiac adverse events with treatment using (a) an anti-IL-23p19 antibody other than hum13B8-b or (b) an anti-IL-17 antibody.

[0312] Embodiment 218: The method according to Embodiment 217, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0313] Embodiment 219: The method according to Embodiment 217, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0314] Embodiment 220: Administration of hum13B8-b reduces the risk of cardiac adverse events compared to treatment with (a) an anti-IL-23p19 antibody other than hum13B8-b, or (b) an anti-IL-17 antibody, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, and at least approximately 22 The method according to Embodiment 217, which is more effective than treatment lasting up to approximately 52 weeks, with a maximum duration of 0 weeks, at least approximately 232 weeks, at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0315] Embodiment 221: The method according to Embodiment 217, wherein hum13B8-b is administered to the patient approximately every 12 weeks.

[0316] Embodiment 222: The method according to Embodiment 217, wherein hum13B8-b is administered subcutaneously to the patient.

[0317] Embodiment 223: The method according to Embodiment 222, wherein hum13B8-b is administered to the patient by subcutaneous injection.

[0318] Embodiment 224: The method according to Embodiment 223, wherein hum13B8-b is administered to the patient using an auto-injector or a pre-filled syringe.

[0319] Embodiment 225: The method according to Embodiment 217, wherein a therapeutically effective dose of hum13B8-b is administered to the patient.

[0320] Embodiment 226: The method according to Embodiment 217, wherein 100 mg or 200 mg of hum13B8-b is administered to the patient.

[0321] Embodiment 227: The method according to Embodiment 226, wherein 100 mg of hum13B8-b is administered to the patient.

[0322] Embodiment 228: The method according to Embodiment 226, wherein 200 mg of hum13B8-b is administered to the patient.

[0323] Embodiment 229: The method according to Embodiment 217, wherein an initial dose of hum13B8-b is administered to the patient in week 0, and subsequent doses of hum13B8-b are administered to the patient approximately every 12 weeks thereafter.

[0324] Embodiment 230: The method according to Embodiment 229, wherein the initial dose and subsequent doses are the same.

[0325] Embodiment 231: The method according to Embodiment 229, wherein the initial dose and subsequent doses are different.

[0326] Embodiment 232: The method according to Embodiment 229, wherein the initial dose is 100 mg.

[0327] Embodiment 233: The method according to Embodiment 229, wherein the initial dose is 200 mg.

[0328] Embodiment 234: The method according to Embodiment 229, wherein the subsequent dose is 100 mg.

[0329] Embodiment 235: The method according to Embodiment 229, wherein the subsequent dose is 200 mg.

[0330] Embodiment 236: The method according to Embodiment 230, wherein the initial dose and subsequent dose are 100 mg.

[0331] Embodiment 237: The method according to Embodiment 230, wherein the initial dose and subsequent dose are 200 mg.

[0332] Embodiment 238: The method according to Embodiment 231, wherein the initial dose is 100 mg and the subsequent dose is 200 mg.

[0333] Embodiment 239: The method according to Embodiment 231, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

[0334] Embodiment 240: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 229, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0335] Embodiment 241: The method according to Embodiment 217, wherein the initial dose of hum13B8-b is administered to the patient in week 0, the second dose of hum13B8-b is administered to the patient in approximately week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter.

[0336] Embodiment 242: The method according to Embodiment 241, wherein the initial dose, the second dose, and the subsequent dose are the same.

[0337] Embodiment 243: The method according to Embodiment 242, wherein the initial dose, the second dose, and the subsequent dose are 100 mg.

[0338] Embodiment 244: The method according to Embodiment 242, wherein the initial dose, second dose, and subsequent dose are 200 mg.

[0339] Embodiment 245: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 241, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0340] Embodiment 246: A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; the pharmaceutical composition is administered to the patient for at least about 60 weeks; and the patient has a reduced risk of cardiac adverse events for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) a pharmaceutical composition of an anti-IL-23p19 antibody other than hum13B8-b, or (b) a pharmaceutical composition of an anti-IL-17 antibody.

[0341] Embodiment 247: The pharmaceutical composition according to Embodiment 246, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0342] Embodiment 248: The pharmaceutical composition according to either Embodiment 246 or Embodiment 247, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0343] Embodiment 249: Administration of the pharmaceutical composition reduces the risk of cardiac adverse events compared to treatment with (a) a pharmaceutical composition of an anti-IL-23p19 antibody other than hum13B8-b, or (b) a pharmaceutical composition of an anti-IL-17 antibody, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, and at least approximately 220 weeks. A pharmaceutical composition according to any one of Embodiments 246 to 248, which is more effective than treatment lasting up to approximately 52 weeks, for at least approximately 232 weeks, for at least approximately 244 weeks, for at least approximately 256 weeks, for at least approximately 268 weeks, for at least approximately 280 weeks, for at least approximately 292 weeks, for at least approximately 304 weeks, for at least approximately 316 weeks, for at least approximately 328 weeks, for at least approximately 340 weeks, for at least approximately 352 weeks, for at least approximately 364 weeks, for at least approximately 384 weeks, for at least approximately 396 weeks, for at least approximately 408 weeks, or for at least approximately 432 weeks.

[0344] Embodiment 250: A pharmaceutical composition according to any one of embodiments 246 to 249, wherein the pharmaceutical composition is administered to a patient approximately every 12 weeks.

[0345] Embodiment 251: A pharmaceutical composition according to any one of embodiments 246 to 250, wherein the pharmaceutical composition is administered subcutaneously to a patient.

[0346] Embodiment 252: A pharmaceutical composition according to any one of embodiments 246 to 251, wherein the pharmaceutical composition is administered to a patient by subcutaneous injection.

[0347] Embodiment 253: A pharmaceutical composition according to any one of embodiments 246 to 252, wherein the pharmaceutical composition is administered to a patient using an auto-injector or a pre-filled syringe.

[0348] Embodiment 254: A pharmaceutical composition according to any one of embodiments 246 to 253, wherein a therapeutically effective amount of the pharmaceutical composition is administered to a patient.

[0349] Embodiment 255: A pharmaceutical composition according to any one of Embodiments 246 to 254, wherein the dosage of the pharmaceutical composition contains 100 mg or 200 mg of hum13B8-b.

[0350] Embodiment 256: The pharmaceutical composition according to Embodiment 255, wherein the dosage of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0351] Embodiment 257: The pharmaceutical composition according to Embodiment 255, wherein the dosage of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0352] Embodiment 258: A pharmaceutical composition according to any one of embodiments 246 to 257, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

[0353] Embodiment 259: The pharmaceutical composition according to Embodiment 258, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are the same.

[0354] Embodiment 260: The pharmaceutical composition according to Embodiment 258, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition are different.

[0355] Embodiment 261: The pharmaceutical composition according to Embodiment 258, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0356] Embodiment 262: The pharmaceutical composition according to Embodiment 258, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

[0357] Embodiment 263: The pharmaceutical composition according to Embodiment 258, wherein the subsequent dose pharmaceutical composition contains 100 mg of hum13B8-b.

[0358] Embodiment 264: The pharmaceutical composition according to Embodiment 258, wherein the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0359] Embodiment 265: The pharmaceutical composition according to Embodiment 259, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 100 mg of hum13B8-b.

[0360] Embodiment 266: The pharmaceutical composition according to Embodiment 259, wherein the initial dose pharmaceutical composition and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0361] Embodiment 267: The pharmaceutical composition according to Embodiment 260, wherein the initial dose pharmaceutical composition contains 100 mg of hum13B8-b, and the subsequent dose pharmaceutical composition contains 200 mg of hum13B8-b.

[0362] Embodiment 268: The pharmaceutical composition according to Embodiment 260, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b, and the subsequent dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

[0363] Embodiment 269: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 258, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0364] Embodiment 270: A pharmaceutical composition according to any one of embodiments 246 to 257, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in approximately week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

[0365] Embodiment 271: The pharmaceutical composition according to Embodiment 270, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition are the same.

[0366] Embodiment 272: The pharmaceutical composition according to Embodiment 271, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 100 mg of humB138-b.

[0367] Embodiment 273: The pharmaceutical composition according to Embodiment 271, wherein the initial dose pharmaceutical composition, the second dose pharmaceutical composition, and the subsequent dose pharmaceutical composition each contain 200 mg of hum13B8-b.

[0368] Embodiment 274: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 270, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0369] Embodiment 275: The use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a pharmaceutical product for the treatment of psoriasis vulgaris in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; the pharmaceutical product is administered to the patient for at least approximately 60 weeks; and the patient has a reduced risk of cardiac adverse events for at least approximately 60 weeks compared to the risk of cardiac adverse events with treatment using (a) an anti-IL-23p19 antibody pharmaceutical product other than hum13B8-b, or (b) an anti-IL-17 antibody pharmaceutical product.

[0370] Embodiment 276: The use according to Embodiment 275, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0371] Embodiment 277: The use according to Embodiment 275, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0372] Embodiment 278: The administration of the drug resulted in a reduced risk of cardiac adverse events compared to treatment with (a) an anti-IL-23p19 antibody drug other than hum13B8-b, or (b) an anti-IL-17 antibody drug, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, and at least approximately 22 weeks. The use described in Embodiment 275, which is obtained by comparing treatment over a period of up to 0 weeks, at least approximately 232 weeks, at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks with treatment over a period of up to approximately 52 weeks.

[0373] Embodiment 279: The use according to Embodiment 275, wherein the drug is administered to the patient approximately every 12 weeks.

[0374] Embodiment 280: The use according to Embodiment 275, wherein the drug is administered subcutaneously to the patient.

[0375] Embodiment 281: The use described in Embodiment 280, wherein the pharmaceutical product is administered to the patient by subcutaneous injection.

[0376] Embodiment 282: The use according to Embodiment 281, wherein the drug is administered to the patient using a self-injector or a pre-filled syringe.

[0377] Embodiment 283: The use according to Embodiment 275, wherein a therapeutically effective amount of the drug is administered to the patient.

[0378] Embodiment 284: The use according to Embodiment 275, wherein the dosage of the drug contains 100 mg or 200 mg of hum13B8-b.

[0379] Embodiment 285: The use described in Embodiment 284, wherein the dosage of the drug contains 100 mg of hum13B8-b.

[0380] Embodiment 286: The use described in Embodiment 284, wherein the dosage of the drug contains 200 mg of hum13B8-b.

[0381] Embodiment 287: The use according to Embodiment 275, wherein the initial dose of the drug is administered to the patient in week 0, and subsequent doses of the drug are administered to the patient approximately every 12 weeks thereafter.

[0382] Embodiment 288: The use according to Embodiment 287, wherein the initial dose of the drug and the subsequent dose of the drug are the same.

[0383] Embodiment 289: The use described in Embodiment 287, wherein the initial dose of the drug and the subsequent dose of the drug are different.

[0384] Embodiment 290: The use according to Embodiment 287, wherein the initial dose of the drug contains 100 mg of hum13B8-b.

[0385] Embodiment 291: The use according to Embodiment 287, wherein the initial dose of the drug contains 200 mg of hum13B8-b.

[0386] Embodiment 292: The use according to Embodiment 287, wherein the subsequent dose of the drug contains 100 mg of hum13B8-b.

[0387] Embodiment 293: The use according to Embodiment 287, wherein the subsequent dose of the drug contains 200 mg of hum13B8-b.

[0388] Embodiment 294: The use according to Embodiment 288, wherein the initial dose and subsequent doses of the drug each contain 100 mg of hum13B8-b.

[0389] Embodiment 295: The use according to Embodiment 288, wherein the initial dose and subsequent doses of the drug each contain 200 mg of hum13B8-b.

[0390] Embodiment 296: The use according to Embodiment 289, wherein the initial dose of the drug contains 100 mg of hum13B8-b, and the subsequent dose of the drug contains 200 mg of hum13B8-b.

[0391] Embodiment 297: The use according to Embodiment 289, wherein the initial dose of the drug contains 200 mg of hum13B8-b, and the subsequent dose of the drug contains 100 mg of hum13B8-b.

[0392] Embodiment 298: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 287, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0393] Embodiment 299: The use according to Embodiment 275, wherein the initial dose of the drug is administered to the patient in week 0, the second dose of the drug is administered to the patient in approximately week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0394] Embodiment 300: The use according to Embodiment 299, wherein the initial dose, the second dose, and the subsequent doses of the drug are the same.

[0395] Embodiment 301: The use according to Embodiment 300, wherein the initial dose, the second dose, and the subsequent dose each contain 100 mg of humB138-b.

[0396] Embodiment 302: The use according to Embodiment 300, wherein the initial dose, the second dose, and the subsequent dose each contain 200 mg of hum13B8-b.

[0397] Embodiment 303: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 299, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0398] Embodiment 304: A method for treating psoriasis vulgaris, comprising administering an anti-IL-23p19 antibody to a patient in need thereof, wherein the patient is administered the anti-IL-23p19 antibody for at least approximately 60 weeks; the administration of the anti-IL-23p19 antibody results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 60 weeks; the administration of the anti-IL-23p19 antibody results in patients maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 60 weeks; and the administration of the anti-IL-23p19 antibody results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 60 weeks compared to treatment for up to approximately 52 weeks.

[0399] Embodiment 305: The method according to Embodiment 304, wherein the AE, drug-related AE, SAE, Tier 1 AE, or Tier 2 AE is a cardiac adverse event.

[0400] Embodiment 306: The method according to Embodiment 304, wherein the patient has a reduced risk of cardiac adverse events for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) an anti-IL-23p19 antibody other than hum13B8-b, or (b) an anti-IL-17 antibody.

[0401] Embodiment 307: The method according to either Embodiment 305 or Embodiment 306, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0402] Embodiment 308: The method according to Embodiment 304, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0403] Embodiment 309: Anti-IL-23p19 antibodies are effective for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 304, wherein the patient is administered the drug for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0404] Embodiment 310: Administration of anti-IL-23p19 antibodies can be used for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least approximately 256 weeks. The method according to Embodiment 304, which results in a patient maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0405] Embodiment 311: Administration of anti-IL-23p19 antibodies can lead to at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. The method according to Embodiment 304, which results in a patient maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0406] Embodiment 312: Administration of anti-IL-23p19 antibodies can lead to at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. The method according to Embodiment 304, which results in a patient maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0407] Embodiment 313: Administration of anti-IL-23p19 antibodies can lead to at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. The method according to Embodiment 304, which results in a patient maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0408] Embodiment 314: Administration of anti-IL-23p19 antibodies can be used for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. The method according to Embodiment 304, which results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0409] Embodiment 315: Administration of anti-IL-23p19 antibodies can reduce the risk of infection for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to Embodiment 304, which results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment lasting up to approximately 52 weeks, for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0410] Embodiment 316: The method according to Embodiment 304, wherein an anti-IL-23p19 antibody is administered to the patient approximately every 12 weeks.

[0411] Embodiment 317: The method according to Embodiment 304, wherein an anti-IL-23p19 antibody is administered subcutaneously to the patient.

[0412] Embodiment 318: The method according to Embodiment 317, wherein an anti-IL-23p19 antibody is administered to the patient by subcutaneous injection.

[0413] Embodiment 319: The method according to Embodiment 318, wherein the anti-IL-23p19 antibody is administered to the patient using an auto-injector or a pre-filled syringe.

[0414] Embodiment 320: The method according to Embodiment 304, wherein a therapeutically effective dose of anti-IL-23p19 antibody is administered to the patient.

[0415] Embodiment 321: The method according to Embodiment 304, wherein 100 mg or 200 mg of anti-IL-23p19 antibody is administered to the patient.

[0416] Embodiment 322: The method according to Embodiment 304, wherein an initial dose of anti-IL-23p19 antibody is administered to the patient in week 0, and subsequent doses of anti-IL-23p19 antibody are administered to the patient approximately every 12 weeks thereafter.

[0417] Embodiment 323: (a) the initial dose and subsequent dose are 100 mg; or (b) the method according to Embodiment 322, wherein the initial dose and subsequent dose are 200 mg.

[0418] Embodiment 324: (a) the initial dose is 100 mg and the subsequent dose is 200 mg; or (b) the method according to Embodiment 322, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

[0419] Embodiment 325: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 322, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0420] Embodiment 326: The method according to Embodiment 304, wherein the first dose of anti-IL-23p19 antibody is administered to the patient at week 0, the second dose of anti-IL-23p19 antibody is administered to the patient at approximately week 4, and subsequent doses of anti-IL-23p19 antibody are administered to the patient every 4 to 12 weeks thereafter.

[0421] Embodiment 327: Subsequent doses are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to Embodiment 326, administered for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0422] Embodiment 328: The method according to any one of Embodiments 304 to 327, wherein the anti-IL-23p19 antibody is hum13B8-b, and hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0423] Embodiment 329: A pharmaceutical composition of an anti-IL-23p19 antibody for the treatment of psoriasis vulgaris in patients; the pharmaceutical composition is administered to patients for at least approximately 60 weeks; administration of the pharmaceutical composition results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 60 weeks; administration of the pharmaceutical composition results in patients maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 60 weeks; and administration of the pharmaceutical composition results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 60 weeks compared to treatment for up to approximately 52 weeks.

[0424] Embodiment 330: The pharmaceutical composition according to Embodiment 329, wherein the AE, drug-related AE, SAE, Tier 1 AE, or Tier 2 AE is a cardiac adverse event.

[0425] Embodiment 331: A pharmaceutical composition according to either Embodiment 329 or Embodiment 330, wherein the patient has a reduced risk of cardiac adverse events for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) a pharmaceutical composition of an anti-IL-23p19 antibody other than hum13B8-b, or (b) a pharmaceutical composition of an anti-IL-17 antibody.

[0426] Embodiment 332: A pharmaceutical composition according to any one of embodiments 329 to 331, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0427] Embodiment 333: The pharmaceutical composition according to any one of embodiments 329 to 332, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0428] Embodiment 334: The pharmaceutical composition will last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. A pharmaceutical composition according to any one of Embodiments 329 to 333, administered to a patient for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0429] Embodiment 335: By administering the pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, at least approximately 256 weeks, and at least approximately 2 A pharmaceutical composition according to any one of Embodiments 329 to 334, which results in a patient maintaining a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for up to 68 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0430] Embodiment 336: By administering the pharmaceutical composition, for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least A pharmaceutical composition according to any one of Embodiments 329 to 335, which results in a patient maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0431] Embodiment 337: By administering the pharmaceutical composition, for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least A pharmaceutical composition according to any one of Embodiments 329 to 335, which results in a patient maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0432] Embodiment 338: By administering the pharmaceutical composition, for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical compositions according to Embodiments 329-335, which result in patients maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0433] Embodiment 339: By administering the pharmaceutical composition, for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and less The pharmaceutical composition according to Embodiments 329-335, which results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0434] Embodiment 340: By administering the pharmaceutical composition, the effects last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least A pharmaceutical composition according to any one of Embodiments 329 to 339, which results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment for up to approximately 52 weeks, including up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0435] Embodiment 341: A pharmaceutical composition according to any one of embodiments 329 to 340, wherein the pharmaceutical composition is administered to a patient approximately every 12 weeks.

[0436] Embodiment 342: A pharmaceutical composition according to any one of embodiments 329 to 341, wherein the pharmaceutical composition is administered subcutaneously to a patient.

[0437] Embodiment 343: A pharmaceutical composition according to any one of embodiments 329 to 342, wherein the pharmaceutical composition is administered to a patient by subcutaneous injection.

[0438] Embodiment 344: A pharmaceutical composition according to any one of embodiments 329 to 343, wherein the pharmaceutical composition is administered to a patient using an auto-injector or a pre-filled syringe.

[0439] Embodiment 345: A pharmaceutical composition according to any one of embodiments 329 to 344, wherein a therapeutically effective amount of the pharmaceutical composition is administered to a patient.

[0440] Embodiment 346: A pharmaceutical composition according to any one of Embodiments 329 to 345, wherein the dosage of the pharmaceutical composition contains 100 mg or 200 mg of anti-IL-23p19 antibody.

[0441] Embodiment 347: A pharmaceutical composition according to any one of embodiments 329 to 346, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

[0442] Embodiment 348: (a) The initial dose and subsequent dose pharmaceutical compositions each contain 100 mg of anti-IL-23p19 antibody; or (b) The initial dose and subsequent dose pharmaceutical compositions each contain 200 mg of anti-IL-23p19 antibody, according to Embodiment 347.

[0443] Embodiment 349: (a) a pharmaceutical composition comprising 100 mg of anti-IL-23p19 antibody in an initial dose and 200 mg of anti-IL-23p19 antibody in a subsequent dose; or (b) a pharmaceutical composition according to Embodiment 347, comprising 200 mg of anti-IL-23p19 antibody in an initial dose and 100 mg of anti-IL-23p19 antibody in a subsequent dose.

[0444] Embodiment 350: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 347, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0445] Embodiment 351: A pharmaceutical composition according to any one of embodiments 329 to 346, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in approximately week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

[0446] Embodiment 352: Subsequent doses of the pharmaceutical composition are administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The pharmaceutical composition according to Embodiment 331, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0447] Embodiment 353: The pharmaceutical composition according to any one of Embodiments 329 to 352, wherein the anti-IL-23p19 antibody is hum13B8-b, and hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0448] Embodiment 354: The use of an anti-IL-23p19 antibody for the manufacture of a drug for the treatment of psoriasis vulgaris in patients, wherein the drug is administered to the patient for at least approximately 60 weeks; administration of the drug results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 60 weeks; administration of the drug results in patients maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least approximately 60 weeks; and administration of the drug results in patients not experiencing an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 60 weeks compared to treatment for up to approximately 52 weeks.

[0449] Embodiment 355: The use according to Embodiment 354, wherein the AE, drug-related AE, SAE, Tier 1 AE, or Tier 2 AE is a cardiac adverse event.

[0450] Embodiment 356: The use according to Embodiment 354, wherein the patient has a reduced risk of cardiac adverse events for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) an anti-IL-23p19 antibody drug other than hum13B8-b, or (b) an anti-IL-17 antibody drug.

[0451] Embodiment 357: The use according to either Embodiment 355 or Embodiment 356, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

[0452] Embodiment 358: The use according to Embodiment 354, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

[0453] Embodiment 359: The drug will last for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 24 The use according to Embodiment 354, administered to the patient for up to 4 weeks, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks.

[0454] Embodiment 360: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, for at least approximately 244 weeks, for at least approximately 256 weeks, The use according to Embodiment 354 results in patients maintaining a physician's global assessment (PGA) score of “clear” or “nearly clear,” with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0455] Embodiment 361: The administration of the drug will last for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The use according to Embodiment 354 results in patients maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0456] Embodiment 362: The administration of the drug will last for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The use according to Embodiment 354 results in patients maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0457] Embodiment 363: The administration of the drug will last for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The use according to Embodiment 354 results in patients maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) for up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0458] Embodiment 364: With the administration of the drug, for at least approximately 60 weeks, at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The use according to Embodiment 354 results in a patient maintaining a 100% reduction in psoriasis area and severity index (PASI 100) for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

[0459] Embodiment 365: With the administration of the drug, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, for at least approximately 244 weeks, at least The use according to Embodiment 354 results in patients who do not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment for up to approximately 52 weeks, for up to approximately 256 weeks, for at least approximately 268 weeks, for at least approximately 280 weeks, for at least approximately 292 weeks, for at least approximately 304 weeks, for at least approximately 316 weeks, for at least approximately 328 weeks, for at least approximately 340 weeks, for at least approximately 352 weeks, for at least approximately 364 weeks, for at least approximately 384 weeks, for at least approximately 396 weeks, for at least approximately 408 weeks, or for at least approximately 432 weeks, compared to treatment for up to approximately 52 weeks.

[0460] Embodiment 366: The use according to Embodiment 354, wherein the drug is administered to the patient approximately every 12 weeks.

[0461] Embodiment 367: The use according to Embodiment 354, wherein the drug is administered subcutaneously to the patient.

[0462] Embodiment 368: The use according to Embodiment 367, wherein the pharmaceutical product is administered to the patient by subcutaneous injection.

[0463] Embodiment 369: The use according to Embodiment 368, wherein the drug is administered to the patient using an auto-injector or a pre-filled syringe.

[0464] Embodiment 370: The use according to Embodiment 354, wherein a therapeutically effective amount of the drug is administered to the patient.

[0465] Embodiment 371: The use according to Embodiment 354, wherein the dosage of the drug contains 100 mg or 200 mg of anti-IL-23p19 antibody.

[0466] Embodiment 372: The use according to Embodiment 354, wherein the initial dose of the drug is administered to the patient in week 0, and subsequent doses of the drug are administered to the patient approximately every 12 weeks thereafter.

[0467] Embodiment 373: (a) The initial dose and subsequent dose of the drug each contain 100 mg of anti-IL-23p19 antibody; or (b) The initial dose and subsequent dose of the drug each contain 200 mg of anti-IL-23p19 antibody, as described in Embodiment 372.

[0468] Embodiment 374: (a) The initial dose of the drug contains 100 mg of anti-IL-23p19 antibody, and the subsequent dose contains 200 mg of anti-IL-23p19 antibody; or (b) The initial dose of the drug contains 200 mg of anti-IL-23p19 antibody, and the subsequent dose contains 100 mg of anti-IL-23p19 antibody, as described in Embodiment 372.

[0469] Embodiment 375: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 374, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0470] Embodiment 376: The use according to Embodiment 354, wherein the initial dose of the drug is administered to the patient in week 0, the second dose of the drug is administered to the patient in approximately week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0471] Embodiment 377: Subsequent doses of the drug are administered approximately every 12 weeks, for at least approximately 64 weeks, for at least approximately 76 weeks, for at least approximately 88 weeks, for at least approximately 100 weeks, for at least approximately 112 weeks, for at least approximately 124 weeks, for at least approximately 136 weeks, for at least approximately 148 weeks, for at least approximately 160 weeks, for at least approximately 172 weeks, for at least approximately 184 weeks, for at least approximately 196 weeks, for at least approximately 208 weeks, for at least approximately 220 weeks, for at least approximately 232 weeks, and at least The use according to Embodiment 376, administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

[0472] Embodiment 378: The use according to any one of Embodiments 354 to 377, wherein the anti-IL-23p19 antibody is hum13B8-b, and hum13B8-b comprises (i) a light chain polypeptide having the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2. [Examples]

[0473] The following embodiments illustrate specific embodiments of the present disclosure and various uses thereof. They are provided for illustrative purposes only and should not be construed as limiting the scope of the present disclosure in any way.

[0474] Disclosed herein is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the long-term (i.e., >52-week) safety and tolerability of tildrakizumab (MK-3222) in subjects with moderate to severe chronic plaque psoriasis.

[0475] Test design Dosage selection Participants who completed the 52-week baseline study were eligible for enrollment in the extension study. Eligible participants received one of two active doses of tildrakizumab (MK-3222), 100 mg or 200 mg, for a minimum of four years. The dose allocation (100 mg or 200 mg) was the same dose the participant received at the end of the baseline study. During the open-label long-term extension phase of the study, participants received tildrakizumab (MK-3222) in either a pre-filled syringe (PFS) or an auto-injector (AI) format.

[0476] Exam period Given the chronic nature of psoriasis, the efficacy and safety profiles of psoriasis treatments need to be established in relatively short-term randomized controlled trials and determined over extended treatment periods. Long-term extension trials provide an opportunity to evaluate the maintenance of long-term safety and efficacy.

[0477] This long-term extension study was designed to provide participants enrolled in the baseline study with the opportunity to continue their treatment for at least an additional four years. During this period, they were regularly monitored for maintenance of their treatment response, as well as the long-term safety and tolerability of subcutaneous tildrakizumab.

[0478] Test group The study enrolled subjects (≥18 years old) with a diagnosis of moderate to severe chronic psoriasis vulgaris (defined by involvement of ≥10% of body surface area at baseline, PGA score ≥3, and PASI score ≥12). Randomized subjects with prior exposure to biologic treatment for psoriasis, and randomized subjects with a diagnosis of psoriatic arthritis at baseline, were enrolled in the baseline study. Subjects undergoing treatment for topical psoriasis (excluding low-potency topical corticosteroids of class VI or VII), conventional systemic psoriasis treatments (e.g., cyclosporine, methotrexate, acitretin, fumarate), or phototherapy (e.g., ultraviolet [UV]-B] phototherapy, psoralen-UVA (PUVA) treatment, tanning salons, or home-administered UVB), treatment with injectable or oral corticosteroids, treatment with biological agents (including monoclonal antibodies and alefacept), treatment with non-biological investigational drugs, and subjects taking biological investigational drugs were excluded from this study.

[0479] treatment In the extension study, participants received 100 mg (n=381) or 200 mg (n=349) of tildrakizumab (MK-3222) or placebo every 12 weeks for a minimum of 212 weeks, following their last dose of treatment in the 52-week base study. Participants received tildrakizumab (MK-3222) delivered via pre-filled syringes (PFS), although some doses were entirely contained within auto-injectors (AI). There was no randomization or stratification in the extension study. Participants received the same dose of tildrakizumab via the PFS or AI received at the end of the base study. Product names are provided in Table 1. [Table 1]

[0480] The trial period was referred to as "Extension 1" from week 60 (visit 15) to week 244 (visit 31); and as "Extension 2" from week 256 to week 264 (visit 35), up to 108 weeks after visit 35 (i.e., from week 364 to week 372) (visit 44). "Extension 3" referred to the trial period including additional treatment visits after visit 44. Evaluations during the extension trials are provided in Tables 2-7. [Table 2] [Table 3] [Table 4] [Table 5] [Table 6] [Table 7]

[0481] Early Termination Visit (ET): A procedure required to be completed within 7 days of early termination for subjects who terminate the trial before the completion of Part 1, 2, or 3. Subjects who terminated early were required to participate in the follow-up period as scheduled.

[0482] Note: Participants were required to continue using the concomitant medications approved in the trial only during the follow-up period; however, at the discretion of the investigator, they may be placed in appropriate treatment for safety concerns or significant exacerbations of psoriasis.

[0483] 1. In cases where a participant was unable to visit the clinical trial site within the visit window as specified in the trial flowchart, the visit could be rescheduled to a different time point with the prior consent of the sponsor. All attempts required to reschedule as close as possible to the original visit date are permitted.

[0484] 2. Informed consent required to be obtained before performing any test procedure.

[0485] 3. Informed consent regarding pharmacogenetic samples required to be obtained prior to DNA samples. DNA samples for analysis are required to be obtained as the last sample taken before drug administration, on day 1 (or with the next scheduled blood draw), only from randomized subjects, or at a later date once informed consent has been obtained. Subjects who did not wish to consent to these procedures could still be included in the study; however, they would not be permitted to have pharmacogenetic samples taken.

[0486] 4. Any subject who initiated prophylactic treatment for latent TB during the screening period could be randomized 4 weeks after the start of treatment without the need for rescreening.

[0487] 5. Only women of childbearing potential were included. Where more frequent pregnancy tests were required by local law, the tests were performed as required. Follicle-stimulating hormone (FST) testing was required only for postmenopausal women <45 years of age, or women with <3 months and <1 year of menstrual cessation>.

[0488] 6. Participation was voluntary only at facilities where it was possible to take full-body photographs. Full-body photographs were used for visual evaluation only and were not included in any analysis. Participants who did not wish to consent to these procedures could still be included in the study, but were not permitted to have full-body photographs taken.

[0489] 7. Blood sample taken before administration at a tildrakizumab (MK-3222) medication visit for measurement of PK and / or ADA of tildrakizumab (MK-3222).

[0490] 8. The safety laboratory tests consisted of the following:

[0491] Hematology: Red blood cells (RBCs), hematocrit, hemoglobin, platelets, white blood cells (WBCs), eosinophils, neutrophils, lymphocytes, monocytes, and basophils

[0492] Chemistry: Potassium, sodium, chloride, bicarbonate, creatinine, blood urea nitrogen (BUN), total bilirubin, alkaline phosphatase, aspartate aminotransferase (AST;SGOT), alanine aminotransferase (ALT;SGPT), gamma-glutamyltransferase (GGT), lactate dehydrogenase (LDH), total protein, albumin, calcium, inorganic phosphorus, glucose, fully fasted lipid panel (lipids at baseline, 12 weeks, and 52 weeks only), and hsCRP

[0493] Urine tests include urine test strips, which measure pH, specific gravity, protein, glucose, ketones, and blood. If the urine test strip is positive (i.e., more than a trace amount), the sample should be sent to the central laboratory for microscopic examination.

[0494] 9. This will only be performed on randomized subjects who report a severe infection during the trial.

[0495] 10. Participants were required to receive their first dose of the study drug within 24 hours of randomization. All evaluations and procedures were required to be performed before administration of the study drug. Participants received twice-weekly self-injections of etanercept or etanercept placebo at home from visit 3 until visit 6 (week 12). Following the dose at visit 6 and until visit 9 (week 28), participants continued to self-administer once-weekly etanercept at home. Participants were also eligible to receive doses of tildrakizumab (MK-3222) or tildrakizumab (MK-3222) placebo at visits 2 and 4, and to self-administer subsequent doses of tildrakizumab (MK-3222) or tildrakizumab (MK-3222) placebo at home from visit 4.

[0496] Up to week 28, the investigational drug administered at the study site was administered by a third-party administrator who remained blinded to the target treatment allocation. This was a precautionary measure in case minor differences in the drug product or primary container were observed.

[0497] 11. Any subjects who discontinued treatment at week 28 (including those who discontinued due to response status) were required to have an ET visit performed in place of the week 28 visit.

[0498] 12. Participants could continue treatment beyond 244 weeks if the product was not expected to be available in the subject's local market, or until the sponsor withdrew its marketing authorization application (for Canada only), whichever came first. Procedures performed during all visits up to 244 weeks continued to be performed at all visits, and procedures that were shifted to be performed at every other visit continued to be performed at every other visit until the start of the follow-up period or until the subject was transferred to a marketed drug.

[0499] 13. Following the database lock of the baseline study, subjects received the investigational drug in an open-label manner for the remainder of the long-term extension study. During this open-label phase of the extension study, tildrakizumab (MK-3222) was delivered either via the same type of PFS, or using the same type of PFS used in the baseline study, but fully contained within the AI.

[0500] 14. All subjects underwent a 20-week follow-up / drug-free period to monitor safety / tolerability, PK, and ADA responses. Subjects returned for two follow-up visits during the follow-up period, occurring at 12 and 20 weeks after their last visit during the treatment period (basic or extended). The follow-up period was not applicable to subjects who were switched from the study drug to a marketed drug at the discretion of the treating investigator. Subjects who were already in a follow-up period before this version of the protocol was implemented resumed the study drug after completing a minimum 12-week follow-up period.

[0501] 15. There were only two visits (visits 33 and 34) required as part of the follow-up period. The visit at week 6 during the follow-up period (visit 32) was no longer required and was excluded (grayed out) for all subjects entering the follow-up period after the implementation of this modification. Subjects were scheduled for their first visit during the follow-up period (visit 33) 12 weeks after their last visit during the treatment period (basic or extended).

[0502] 16. The patient visit number may change for patients who have received treatment for more than 244 weeks.

[0503] 17. For all ongoing subjects, informed consent for protocol modifications was required to be obtained at the subject's next scheduled / unscheduled visit, and no later than V35. If a subject was currently in the follow-up period and tildrakizumab was commercially available by the time V35 was scheduled, the subject was required to return for their next scheduled follow-up visit to sign the ICF document. The date the subject switched to the commercially available drug and the number of weeks completed during the follow-up period were required to be described in the original document.

[0504] 18. ET visits were required only if the subject discontinued treatment early (after V35 / during extension 2) and before the drug became commercially available or before the marketing authorization application was withdrawn by the sponsor (Canada only). Follow-up periods are applicable to these subjects.

[0505] 19. To enter Extension 3, a minimum of 12 weeks of treatment-free interval was required between the last dose administered in Extension 2 and the first dose administered at the Extension 3 visit. Subjects who were already in the follow-up period before this version of the protocol was implemented resumed the study drug after completing a minimum of 12 weeks of the follow-up period. The maximum time frame for conducting visit 60 (start of Extension 3) was 20 weeks [+7 days] after the last dose in Extension 2 (this could be individual visits depending on the subject's schedule at the end of the Extension 2 trial).

[0506] 20. For all ongoing subjects in Canada, informed consent regarding this protocol modification was required to be obtained at the subject's next scheduled / unscheduled visit, but no later than the 60th visit (the first visit in Extension 3). If a subject was in the follow-up period up to the time when the first visit in Extension 3 could be scheduled, the subject was required to return for the next scheduled follow-up visit and sign the ICF.

[0507] 21. All subjects underwent a 20-week follow-up / drug-free period to monitor safety / tolerability, PK, and ADA response. Subjects returned for two follow-up visits during the follow-up periods that occurred at 12 and 20 weeks after the subject's last visit during the three extended treatment periods. Follow-up periods were not applicable to subjects who switched to commercially available drugs. Subjects could switch to commercially available drugs at the discretion of the treating investigator. If a subject switched to a commercially available drug, the subject was required to return for a final visit 12 weeks after the last dose of the study drug to which the subject was switched to the commercially available drug. The date on which a subject switched to a commercially available drug or the new treatment was required to be recorded in the source documentation, and follow-up of any appropriate safety documentation (for AEs and concomitant medications only) was required.

[0508] Procedures performed during all visits up to 60+48 weeks continued to be performed at all visits, and procedures that were shifted to every other visit continued to be performed at every other visit until the start of the follow-up period or until the subject transitioned to commercially available medication.

[0509] 23. ET visits were required only if the subject discontinued treatment early, i.e., after V60 / extension 3, and before the drug became commercially available or before the marketing authorization application was withdrawn by the sponsor. Follow-up periods are applicable to these subjects.

[0510] Test design The study design was a long-term safety extension study in subjects with moderate to severe chronic plaque psoriasis, following a 52-week, phase 3, randomized, active-controlled and placebo-controlled, parallel-design trial to evaluate the efficacy and safety / tolerability of subcutaneous tildrakizumab.

[0511] There was no randomization or stratification in the extension studies. Participants received tildrakizumab 100 mg or 200 mg every 12 weeks via pre-filled syringes or auto-injectors, which was the same treatment they received at the completion of the base study. The long-term extension studies were conducted first in a double-blind format and then in an open-label format after the base study database lock. Eligible participants were enrolled for a minimum of 212 weeks from the time they participated in the extension study (extension 1), which included 192 weeks of treatment, followed by a 20-week follow-up period to monitor safety / tolerability, PK, and ADA response. Participants continued to receive tildrakizumab treatment beyond 244 weeks (extension 2 [from visit 31] and extension 3 [from visit 44]).

[0512] Measured variables The measured efficacy variables included Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90, and PASI 100, as well as the PGA response. The measured pharmacokinetic variables included exposure to tildrakizumab (MK-3222), covariates influencing the PK behavior of tildrakizumab, and correlations between PK patterns and efficacy parameters. The measured immunogenicity variables included anti-drug antibody (ADA) status (positive or negative / uncertain, expressed under treatment or untreated, neutralizing antibody positive or negative), as well as its correlations with PK, efficacy, and safety.

[0513] Analysis group Four datasets were analyzed: (1) the largest analysis population (FAS), including all subjects who entered the extension trial and received at least one dose of the extension trial treatment, based on assigned treatment; (2) all treated subjects (ASaT), including all subjects who entered the extension trial and received at least one dose of the extension trial treatment, based on treatment received; (3) all subjects who were PK-evaluable, entered the extension, and had at least one PK data point after administration of tildrakizumab; and (4) all subjects who were ADA-evaluable, entered the extension phase, and had at least one ADA data point after administration of tildrakizumab. The FAS was used for efficacy analysis.

[0514] Psoriasis Area and Severity Index The PASI (Peripheral Area Severity Index), a quantitative assessment score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance, was used to measure erythema (redness), induration (thickness), scaling, and plaque coverage (i.e., body surface area covered with lesions) in subjects. Measurements were taken at the time points shown in Tables 2–4. PASI scores range from 0 (no psoriasis on the body) to 72 (most severe cases of psoriasis). PASI 50, PASI 75, PASI 90, and PASI 100 represent states that achieved a reduction of ≥50%, ≥75%, ≥90%, and 100% from baseline in the PASI score, respectively.

[0515] Overall evaluation of the physician The overall severity of psoriasis lesions using PGA at specific time points was determined as shown in Tables 2-4. Lesions were graded on a 0-5 point scale for thickness, erythema, and scaling. The final PGA score was obtained by dividing the sum of the three scales by 3.

[0516] Adverse events According to the ICH, an AE is defined as any undesirable medical occurrence in a patient or clinical study subject administered a medicinal product, and does not necessarily have to be causally related to the treatment. An AE is therefore any undesirable, unintended sign (including, for example, an abnormal laboratory finding), symptom, or disease that is temporally associated with the use of a medicinal product, regardless of whether it is considered to be related to the medicinal product or not.

[0517] Table 9 provides lists of Tier 1, Tier 2, and Tier 3 safety endpoints. For adverse events (specific terms and organ-specific broad classification terms) not previously identified as Tier 1 or Tier 2 endpoints, Tier 2 membership requires that at least four subjects in any treatment group exhibit the event; all other adverse events must belong to Tier 3. Continuous measurements, such as changes from baseline in laboratory tests, vital signs, and ECG parameters not previously identified as Tier 1 endpoints, were considered Tier 3 safety parameters.

[0518] Serious adverse events SAE is any adverse medical event or effect at any dose: 1. It led to death; 2. It was life-threatening; 3. Request hospitalization or extension of hospitalization for an existing patient; 4. To cause lasting or significant impairment or inability; and / or 5. The child had a congenital anomaly or birth defect; 6. It was cancer; 7. Associated with overdose; 8. It was another important medical event.

[0519] In the definition of SAE, life-threatening refers to an event in which the subject had a risk of death at the time of the event; it does not refer to an event that would have hypothetically caused death if it had been more severe.

[0520] Medical judgment required to be performed when determining whether an AE / reaction is serious in other contexts. Significant AEs / reactions that were not immediately life-threatening or did not result in death or hospitalization, but which endangered the subject or required intervention to prevent one of the other outcomes listed in the definition above, had to be considered serious. These were considered "other significant medical events."

[0521] Adverse events of particular note Adverse events of particular interest, identified as pre-configured "Tier 1" safety / tolerability assessment items: • Severe infection • Malignant tumors (excluding cervical intraepithelial carcinoma) ·Non-melanoma skin cancer • Confirmed extended MACE • Drug-related hypersensitivity reactions (e.g., anaphylaxis, urticaria, angioedema).

[0522] Clinical laboratory evaluation - safety Laboratory tests for hematology, highly sensitive C-reactive protein (hsCRP), blood chemistry, and urinalysis (Table 8) were performed at the time points specified in Sections Tables 2–4. Blood samples for laboratory testing were taken prior to administration of the investigational product, and analysis was performed using standard laboratory procedures. Test results that were outside the normal range and considered clinically significant by the principal investigator were repeated at appropriate time intervals until the results returned to baseline or were determined not to be clinically significant. [Table 8]

[0523] Vital signs measurement Vital signs were obtained at the time points specified in Tables 2–4. Systolic and diastolic blood pressure (mm Hg), respiratory rate, heart rate (bpm) rate (bpm), and temperature were recorded. Clinically significant changes in vital sign measurements from baseline were recorded as adverse events.

[0524] 12 lead ECG 12-lead electrocardiograms (ECGs) were performed at the time points specified in Tables 2-4. Clinically significant changes in subsequent ECGs from baseline were recorded as adverse events.

[0525] Physical examination A complete physical examination was performed on all subjects at the time points specified in Tables 2–4. Any medical conditions found during screening and baseline physical examinations in the baseline study were recorded, and clinically significant changes from screening and / or baseline physical examinations were recorded as adverse events.

[0526] Pharmacokinetic measurements A minimum of 2 mL of blood sample was collected in a suitable tube before administration of the test drug at the time points specified in Tables 2-4 to determine the serum concentration of tildrakizumab. The sample collection time was recorded.

[0527] Serum tildrakizumab assays were performed using validated electrochemiluminescence immunoassays (ECL). During the study period, three different validated ECL methods were used, all of which had a conventional cross-linked assay design, using biotinylated hIL-23 as the capture reagent and Meso Scale Discovery® SULFO-TAG® labeled IL-23 or anti-tildrakizumab antibody as the detection reagent. Responses were read on the MesoScale Discovery® platform (with a limit of quantification of 3.12 ng / mL or 20 ng / mL when using SULFO-TAG® labeled IL-23, and 25 ng / mL when using SULFO-TAG® anti-tildrakizumab).

[0528] Immunogenicity measurement A minimum of 6 mL of blood sample was collected in a suitable tube for determination of anti-tildrakizumab antibody prior to administration of the test drug at the time points specified in Tables 2-4. A validated cross-linked electrochemiluminescence immunoassay was used for the detection of ADA in human serum. Biotin and SULFO-TAG®-labeled tildrakizumab were used for capture and detection of anti-tildrakizumab antibody, respectively. Assay responses were read on the MesoScale Discovery® platform. The drug resistance level for the anti-tildrakizumab ADA assay was 6 μg / mL for 500 ng / mL of ADA in serum. Bioanalysis of ADA was performed using a standard three-tier assay approach consisting of screening (Tier 1), confirmation (Tier 2), and antibody characterization (titer and neutralizing ability) (Tier 3). For confirmed ADA-positive samples, the immune response was further characterized in terms of antibody titer and neutralizing ability, specifically ADA's ability to neutralize the binding of tildrakizumab to its biological target (hIL-23).

[0529] Data Quality Assurance Clinical trials were subjected to quality control (QC) and quality assurance monitoring, including independent audits. Quality control and quality assurance activities were inherent in all clinical trial-related activities. Such activities included, but were not limited to, on-site monitoring, including verification of source data, medical monitoring of clinical trial data and resulting databases, and quality review of documents submitted to regulatory authorities.

[0530] statistical analysis The primary efficacy endpoint for this study was the proportion of subjects with a Psoriasis Area and Severity Index (PASI) 50 response over time among ACR 50 responders at week 52 of the baseline study. The second endpoint was the proportion of subjects with a PASI 75 response over time among PASI 75 responders at week 52. The third endpoint was the proportion of subjects with a PASI 90 response over time among PASI 90 responders at week 52. The fourth endpoint was the proportion of subjects with a PASI 100 response over time among PASI 100 responders at week 52. The fifth endpoint was the proportion of subjects with a physician's global assessment (PGA) score of "clear" or "minimal" and a decrease of at least two grades over time from baseline. The sixth endpoint was the change and percentage change in SIP score over time from baseline in the baseline study.

[0531] General approach Continuous data were assumed to be normally distributed and summarized in terms of mean, standard deviation (SD), median, minimum, maximum, and number of observations. Categorical data were summarized in terms of the number of subjects (n) providing data at the relevant time point, frequency, and percentage. Percentages were presented to one decimal place. Percentages were not presented for zero counts. Percentages were calculated using (n) as the denominator.

[0532] Output was generated using SAS® version 9.2 or later. Reporting procedures were used to generate all tables and lists whenever possible. GPLOT procedures were used to generate all figures whenever possible. All statistical appendices (supporting SAS output) were generated directly from appropriate SAS procedures.

[0533] Analysis group The analysis populations analyzed in the extension trial were as follows: (1) Largest Analysis Population (FAS): All subjects who entered the extension trial and received at least one dose of the extension trial treatment based on their assigned treatment; (2) All Treated Subjects (ASaT): All subjects who entered the extension and received at least one dose of the extension trial treatment based on their treatment; (3) PK-evaluable subjects: All subjects who entered the extension and had at least one PK data point after administering tildrakizumab; (4) ADA-evaluable subjects: All subjects who entered the extension and had at least one ADA data point after administering tildrakizumab.

[0534] Baseline characteristics Baseline PASI and PGA scores, as well as baseline characteristics including medical status, were summarized by treatment group and overall for all subjects who advanced to the extension study. Statistical hypothesis testing was not performed on these characteristics.

[0535] Treatment compliance Drug accountability data were collected for tildrakizumab (MK-3222) during the extension study. Compliance was measured for subjects: (1) receiving unscheduled study drug injections, (2) missing injections, and (3) receiving incorrect study drug doses. The number and percentage of subjects and injection visits with any deviations in these measurements were reported. Compliance was calculated using the following formula: Compliance Percentage = Number of Injections Received / Number of Injections the Patient Should Have Received × 100. Summary statistics were provided for all randomized subjects with respect to percentage compliance by treatment group and overall.

[0536] Degree of exposure The duration (in weeks) of the study drug and the average number of weeks of study drug use were calculated based on the subjects' participation only during the extension trial, and on the treatment group to which they were initially randomized during both the base trial and the extension trial.

[0537] Methodology for effectiveness evaluation items For all efficacy outcomes, baseline was defined as the last measurement taken before the first investigational drug in the baseline study. Week 52 was the last scheduled assessment recorded before the final dose in the baseline study. Descriptive summary statistics were provided by the treatment group for all time-series efficacy endpoints during the extension study. Formal statistical analyses were not performed to compare the two tildrakizumab (MK-3222) doses. Descriptive summary statistics were provided by the treatment group (tildrakizumab 100 mg and 200 mg groups) for all safety parameters.

[0538] Methodology for Safety Evaluation Items Safety and tolerability were assessed by a clinical review of all relevant parameters, including adverse events (AEs), laboratory tests, 12-lead ECG, and vital sign measurements. Inter-treatment comparisons were not performed in the extension study. Descriptive summary statistics were provided for all safety parameters by treatment group (tildrakizumab 100 mg and 200 mg groups). Table 9 provides a summary of Tier's safety endpoints. [Table 9]

[0539] Methodology for pharmacokinetic evaluation items Descriptive statistics for tildrakizumab (MK-3222) concentrations were presented by time point and treatment group. Serum concentrations of tildrakizumab (MK-3222) at each nominal sample time were calculated and reported, including: arithmetic mean, SD, arithmetic coefficient of variation, median, standard error (SE), range, geometric mean, geometric coefficient of variation, and number of observations. Values ​​below the limit of quantification were imputed as half a level lower than the quantification to enable reporting of the geometric mean. Data were reported to three significant figures, and the coefficient of variation values ​​were rounded to one decimal place. Furthermore, the effect of ADA status on tildrakizumab (MK-3222) serum concentrations was explored. PK concentrations were simulated for all subjects in this study.

[0540] Methodology for Immunogenicity Assessment Items The results of the post-dose ADA assay were evaluated for immunogenicity assessment. As used herein, “post-dose sample” refers to a sample collected after administration of tildrakizumab. Subjects were grouped based on the actual treatment received, rather than the treatment group at randomization, and baseline samples were collected before dose to evaluate pre-existing antibodies detectable by the ADA assay. A subject was considered positive if at least one post-dose sample was positive in the ADA confirmatory assay. Positive subjects were classified as positive under treatment if the positive sample occurred after treatment with tildrakizumab, or positive under non-treatment if the subject had an immune response present at baseline and the response was not boosted after treatment.

[0541] Samples with negative test results in screening or confirmatory anti-tildrakizumab assays were confirmed to be negative if the tildrakizumab concentration was below 6 μg / mL. Tildrakizumab levels above 6 μg / mL exceed the drug resistance level (DTL) and may interfere with the ADA assay. The immunogenicity status of subjects was confirmed to be negative if all pre-treatment and post-treatment samples were negative in confirmatory assays, and if the tildrakizumab concentration in the sample after the last dose was below the DTL.

[0542] The subjects were classified into immunogenicity categories as shown in Table 10. The overall incidence of immunogenicity was defined as the proportion of positive subjects that developed under treatment relative to the number of evaluable subjects. The proportion of positive subjects that developed under untreated conditions was reported similarly. For ADA-positive subjects (based on confirmatory assays), the immune response was further characterized in terms of antibody titer and neutralizing ability. [Table 10]

[0543] Test subjects Placement of the target Table 11 provides the arrangement of all subjects by treatment group for the extension trials (extensions 1, 2, and 3).

[0544] The tildrakizumab 100 mg group 1 included 381 subjects, and the tildrakizumab 200 mg group 2 included 349 subjects. The percentage of subjects who completed extension 1 was similar between the two treatment groups (290 subjects [76.1%] and 272 subjects [77.9%] in the tildrakizumab 100 mg and 200 mg groups, respectively). Of the 730 subjects who entered extension 1, 166 (22.7%) discontinued the study (23.6% and 21.8% in the tildrakizumab 100 mg and 200 mg groups, respectively). The most common reason for discontinuation in each treatment group during extension 1 was subject dropout (8.1% overall, and 9.2% and 6.9% in the tildrakizumab 100 mg and 200 mg groups, respectively). A total of 455 individuals (62.3%) entered the extended follow-up period, while 273 individuals (37.4%) did not.

[0545] After the completion of Extension 1 follow-up, 249 subjects entered Extension 2. In total, 95 subjects entered Extension 2, and 51 subjects did not enter the Extension 2 follow-up period.

[0546] A total of 31 subjects entered extension 3 (20 subjects in the tildrakizumab 100 mg group and 11 subjects in the 200 mg group). All subjects completed extension 3. [Table 11] TIFF2026518199000012.tif213168

[0547] Protocol deviation Table 12 provides an overall summary of major protocol deviations for all subjects who entered the extended trial. The most common major protocol deviations were related to informed consent (310 subjects [42.5%]), investigational product administration or study treatment (143 subjects [19.6%]), and treatment or examination (110 subjects [15.1%]). [Table 12]

[0548] Demographic characteristics and baseline characteristics Table 13 summarizes the treatment-group and overall characteristics of all subjects who entered the extension trial. [Table 13] TIFF2026518199000015.tif161167

[0549] Baseline disease characteristics A summary of baseline efficacy endpoints is provided in Table 14 for all subjects who advanced to the extension trial, categorized by treatment group. [Table 14]

[0550] Baseline efficacy parameters were similar between treatment groups. The mean baseline SIP score was 19.8 and 19.3 in the tildrakizumab 100 mg and 200 mg groups, respectively. Overall, 62.1% of patients had a PGA score of 3, compared to 62.5% and 61.6% in the tildrakizumab 100 mg and 200 mg groups, respectively.

[0551] Treatment compliance Treatment compliance for the overall extension trials (a combination of extensions 1, 2, and 3) is summarized by treatment group for all subjects randomized in the extension trials shown in Table 15. [Table 15]

[0552] The mean overall compliance during the extension trial was 82.95%. No significant differences were observed between treatment groups in treatment compliance (82.84% and 83.03% in the tildrakizumab 100 mg and 200 mg groups, respectively).

[0553] Degree of exposure A summary of the level of exposure to tildrakizumab 100 mg and 200 mg is provided by treatment group for all randomized subjects in the extension study shown in Table 16.

[0554] The median number of weeks in the tildrakizumab group was 192.0 weeks in the tildrakizumab 100 mg group and 192.0 weeks in the tildrakizumab 200 mg group. [Table 16]

[0555] Effectiveness and other evaluations Example 1.5 Time-dependent PASI50 response among PASI50 responders at week 2 PASI50 response was maintained throughout the extension study among those who were responders at week 52, in the remaining subjects in the study at the specified time point (≥97.9% and ≥95.7% of subjects in the tildrakizumab 100 mg and tildrakizumab 200 mg groups, respectively). See Table 17. [Table 17] TIFF2026518199000020.tif219168

[0556] Example 2.5 Time-dependent PASI75 response among PASI75 responders at week 2 The PASI75 response was maintained throughout the extension study among those who were PAS75 responders at week 52, in the remaining subjects at specified time points, and was enhanced in the tildrakizumab 100 mg group than in the tildrakizumab 200 mg group at almost all time points (≥91.3% and ≥87.1% of subjects in the tildrakizumab 100 mg and 200 mg groups, respectively). See Table 18. [Table 18] TIFF2026518199000022.tif115168

[0557] Example 3.5 Time-dependent PASI90 response among PASI90 responders at week 2 The PASI90 response was maintained throughout the extension study among those who were PASI90 responders at week 52, in the remaining subjects at the identified time points, and was enhanced in the tildrakizumab 100 mg group than in the tildrakizumab 200 mg group for most of the time points (≥80.2% and ≥73.6% of subjects in the tildrakizumab 100 mg and 200 mg groups, respectively). See Table 19. [Table 19] TIFF2026518199000024.tif249167

[0558] Example 4.5 Time-dependent PASI100 response among PASI100 responders at week 2 The proportion of subjects with a PASI100 response over time among those who were PASI100 responders at week 52. The proportion of subjects with a PASI100 response decreased by approximately 20 percentage points from week 60 to week 244 during the extension study in both treatment groups (from 84.0% to 65.7% in the tildrakizumab 100 mg group and from 79.8% to 62.4% in the tildrakizumab 200 mg group). From week 268 to week 384 (during extensions 2 and 3), the proportion of subjects with a PASI100 response increased (from 68.4% to 100% in the tildrakizumab 100 mg group and from 58.6% to 100% in the tildrakizumab 200 mg group). See Table 20. [Table 20] TIFF2026518199000026.tif143167

[0559] Example 5. Time-dependent PASI 75 response, PASI 90 response, and PASI 100 response The proportions of subjects with PASI 75, PASI 90, and PASI 100 responses over time are summarized for each treatment group in Table 21. Within each PASI response (i.e., PASI 75, PASI 90, and PASI 100), the proportion of subjects with a PASI response was maintained throughout the extension study among subjects remaining in the extension study at the specified time points. The proportions of subjects with PASI 75, PASI 90, and PASI 100 responses over time did not differ between subjects treated with PFS and those treated with AI. The proportion of subjects with a PASI 75 response was higher in subjects who self-injected than in subjects who did not self-inject for most of the time points in the tildrakizumab 100 mg group. The proportion of subjects with a PASI 90 or PASI 100 response was higher in subjects who self-injected than in subjects who did not self-inject for most of the time points in the extension study in both treatment groups. [Table 21] TIFF2026518199000028.tif141168

[0560] Example 6. Changes in SIP score over time and percentage changes Summary (FAS) of the change from baseline in PASI scores over time (Table 22) and the percentage change (Table 23). The mean change in PASI scores was maintained in both treatment groups during the extension study. Similarly, the mean percentage change in PASI scores was maintained in both treatment groups over time. No meaningful differences in the change from baseline in PASI scores over time were observed between subjects treated with PFS and subjects treated with AI. [Table 22] TIFF2026518199000030.tif255167TIFF2026518199000031.tif104168 [Table 23] TIFF2026518199000033.tif255167TIFF2026518199000034.tif197168

[0561] Example 7. PGA score “disappearance” or “minimum” with a decrease of at least two grades from baseline over time. Table 24 provides the proportion of subjects who experienced a PGA score of "disappearance" or "minimum" with a decrease of at least two grade points from baseline during the extension study over time. The proportion of subjects with a PGA score of "disappearance" or "minimum" with a decrease of at least two grade points from baseline was similar at most time points in the two treatment groups and was maintained during the extension study. The proportion of subjects with a PGA score of "disappearance" or "minimum" with a decrease of at least two grade points from baseline did not differ between subjects treated with PFS and subjects treated with AI during the extension study. The proportion of subjects with a PGA score of "disappearance" or "minimum" with a decrease of at least two grade points from baseline was higher at most time points in subjects who initiated self-injection of tildrakizumab in both treatment groups, particularly in the tildrakizumab 200 mg group, compared to subjects who did not self-inject. [Table 24] TIFF2026518199000036.tif147167

[0562] Example 8. Percentage of subjects who self-injected using a pre-filled syringe. Table 25 shows the percentage of subjects who self-injected using PFS for the largest analysis population. The percentage of subjects who self-injected using PFS ranged from 65.9% to 76.9% up to week 124, and was similar across the two treatment groups. [Table 25]

[0563] Example 9. Percentage of subjects who self-injected using an auto-injector (AI). The proportion of subjects who self-injected using AI is provided for the largest analysis population at each point in time, and the treatment groups are shown in Table 26. The proportion of subjects who self-injected using AI increased as they shifted from PFS to AI, and was slightly higher in the tildrakizumab 100 mg group compared to the tildrakizumab 200 mg group. [Table 26] TIFF2026518199000039.tif173167

[0564] Example 10. Use of auto-injectors (AIs), proportion of subjects, clinical experience, and device failures. The percentage of subjects treated with AI who experienced any adverse events or device failures is provided in Table 27, by time point and treatment group. The percentages of subjects experiencing any adverse events or device failures were ≤0.5% and ≤1.6%, respectively. [Table 27] TIFF2026518199000041.tif153167

[0565] Pharmacokinetics Pharmacokinetic samples were analyzed over a four-year period from collection using three different validated methods. The majority of the samples (i.e., 11,658 out of 12,868) were analyzed within one year of collection. Approximately 914 of the 12,868 samples were analyzed within two years of collection. PK tables, figures, and lists, and PK concentration data were determined. Overall, the mean concentrations of tildrakizumab from week 76 to week 244 in extension 1 were comparable across the dose groups. The mean concentration of tildrakizumab in the 200 mg dose group was higher than in the 100 mg dose group, but showed a dose-dependent increase in PK.

[0566] Immunogenicity analysis ADA samples were analyzed over a period of 4.5 years from collection. Of the 12,441 samples analyzed, 12,394 samples were analyzed within a period of 3.6 years, which is the longest stability period reported in the literature for ADA (Pihl et al., Bio Analytical 6(10):1409-13(2014)). The ADA evaluable population included subjects with at least one ADA sample after administration of tildrakizumab.

[0567] Example 11. Incidence of anti-drug antibodies The anti-tildrakizumab immunogenicity status at the end of the base study and the end of the extension study is provided by the ADA-evaluable subjects in the extension study, as shown in Table 28. [Table 28]

[0568] Of the 725 individuals eligible for ADA evaluation, 586 (80.8%) had definitive results. 491 (67.7%) were ADA-negative, and 95 (13.1%) were ADA-positive. Of these, 39 (5.4%) were ADA-positive untreated, and 56 (7.7%) were ADA-positive under treatment.

[0569] The proportion of ADA-positive subjects was similar between the two treatment groups (53 subjects [14.0%] in the tildrakizumab 100 mg group and 42 subjects [12.1%] in the tildrakizumab 200 mg group). The proportion of ADA-positive subjects who developed under treatment was higher in the tildrakizumab 100 mg group (35 subjects [9.2%]) compared to the tildrakizumab 200 mg group (21 subjects [6.1%]). The maximum post-dosing titer of subjects ranged from <1 (expressed as 0.5) to 2048. Across the treatment groups, 13 (1.8%) of ADA-positive subjects who developed under treatment and 4 (0.6%) of ADA-positive subjects who developed untreated had at least one sample test positive for neutralizing antibodies (NAb). The proportion of subjects with positive NAb positivity both under treatment and untreated was lower in both treatment groups (<2%).

[0570] Example 12. Correlation between anti-drug antibodies and efficacy A summary of the proportion of subjects with anti-tildrakizumab immunogenicity and PASI 75 response in the extension study is provided in Table 29, sequentially by subject immunogenicity category. The number of subjects with positive NAb positivity under treatment at each time point during the extension study was ≤10 in the PASI 75 response tildrakizumab 100 mg group and ≤3 in the tildrakizumab 200 mg group. Of these, the proportion of subjects achieving a PASI 75 response ranged from 75% to 86% in the tildrakizumab 100 mg group and from 33% to 100% in the tildrakizumab 200 mg group at each time point up to week 244. [Table 29] TIFF2026518199000044.tif255164TIFF2026518199000045.tif255165TIFF2026518199000046.tif184167

[0571] The proportion of subjects with a PASI 75 response was smaller than that of subjects with positive NAb-negative response under treatment at most time points among subjects with positive NAb-positive response under treatment. The number of subjects in the ADA inconclusive and ADA-negative categories was increased compared to subjects in the ADA positive and NAb-negative categories with positive NAb-positive response under treatment. The proportion of ADA inconclusive or negative subjects with a PASI 75 response was high at each time point during the extension study (ranging from 84% to 100% and 89% to 100% in the tildrakizumab 100 mg group, respectively, and from 80% to 100% and 83% to 100% in the tildrakizumab 200 mg group, respectively).

[0572] The proportion of subjects with a PASI 75 response was higher in subjects with ADA inconclusive, ADA negative, and total ADA evaluable responses compared to subjects with positive NAb positivity expressed under treatment.

[0573] The number of NAb-positive subjects who developed positive NAb positivity under treatment with PASI 90 and 100 responses was small at each time point during the extension study in both treatment groups (≤10 in the tildrakizumab 100 mg group and ≤3 in the tildrakizumab 200 mg group).

[0574] The proportion of subjects with positive NAb positivity and a PASI 90 response developed under treatment ranged from 0% to 86% in the tildrakizumab 100 mg group (up to week 316) and from 33% to 100% in the tildrakizumab 200 mg group (up to week 340) at each time point. The proportion of subjects with positive Nab negativity and a PASI 90 response developed under treatment ranged from 78% to 100% in the tildrakizumab 100 mg group (up to week 340) and from 50% to 100% in the tildrakizumab 200 mg group (up to week 316) at each time point. After the aforementioned time points, there were no subjects in either of the two treatment groups in either of the two ADA categories.

[0575] The proportion of subjects with positive NAb positivity and a PASI100 response developed under treatment ranged from 0% to 57% in the tildrakizumab 100 mg group (up to week 316) and from 0% to 50% in the tildrakizumab 200 mg group (up to week 340) at each time point. The proportion of subjects with positive Nab negativity and a PASI100 response developed under treatment ranged from 33% to 100% in the tildrakizumab 100 mg group (up to week 340) and from 9% to 100% in the tildrakizumab 200 mg group (up to week 316) at each time point. After the aforementioned time points, there were no subjects in either of the two treatment groups in either of the two ADA categories.

[0576] Notable differences in the proportion of subjects with a PASI 90 response were less observed in ADA indeterminate, ADA negative, and all ADA evaluable subjects than in subjects with treatment-induced positive NAb positivity. The proportion of subjects with a PASI 100 response was slightly higher in ADA indeterminate, ADA negative, and ADA evaluable subjects than in subjects with treatment-induced positive NAb positivity in the tildrakizumab 100 mg group.

[0577] Example 13. Correlation between antidrug immunogenicity status and PGA score "disappearance" or "minimum" over time. A summary of the anti-tildrakizumab immunogenicity status and proportions of subjects with a PGA score of "minimum" or "clear" over time, accompanied by at least a two-grade decline from baseline, during the extension study, is provided in Table 30 by subject immunogenicity category. [Table 30] TIFF2026518199000048.tif255167TIFF2026518199000049.tif254167TIFF2026518199000050.tif153167

[0578] The number of subjects who developed positive NAb positivity under treatment and had a PGA score of "clear" or "minimum" was small at each time point during the extension study (≤10 subjects in the tildrakizumab 100 mg group and ≤3 subjects in the tildrakizumab 200 mg group). Of these, the proportion of subjects with a PGA score of "minimum" or "clear" ranged from 63% to 86% in the tildrakizumab 100 mg group (excluding week 268 onwards if there was only one subject with a PGA score of "minimum" or "clear"), and from 33% to 100% in the tildrakizumab 200 mg group (excluding week 220 if there was only one subject with a PGA score of "minimum" or "clear").

[0579] The proportion of subjects with a PGA score of "minimum" or "clear" was similar between the total ADA evaluable subjects and subjects with positive NAb-positive development under treatment with tildrakizumab 100 mg, although it was slightly higher in the total ADA evaluable subjects than in subjects with positive NAb-positive development under treatment with tildrakizumab 200 mg. The proportion of subjects with a PGA score of "minimum" or "clear" was higher in subjects with positive NAb-negative development under treatment than in subjects with positive NAb-positive development under treatment at most time points. The number of subjects with positive NAb-positive development under treatment and subjects with positive NAb-negative development under treatment was small. Also, the number of subjects with positive NAb-positive development under treatment at each time point in both treatment groups was smaller than the number of subjects with positive NAb-negative development under treatment.

[0580] The proportion of ADA inconclusive or negative subjects achieving a PGA score of "minimum" or "clear" ranged from 61% to 100% and 63% to 100% in the tildrakizumab 100 mg group and from 62% to 100% and 62% to 89% in the tildrakizumab 200 mg group, respectively, at each time point during the extension study.

[0581] Summary of efficacy, pharmacokinetic, and immunogenicity results conclusion Efficacy results: Baseline efficacy parameters were generally similar between the two treatment groups. PASI 50, PASI 75, and PASI 90 responses among responders at week 52 in both tildrakizumab treatment groups were maintained at the identified time points throughout the extension study for the majority of remaining subjects in the trial. The proportion of subjects with a PASI 100 response among responders at week 52 decreased by approximately 20 percentage points from week 60 to week 244 in both treatment groups. PASI 50, PASI 75, PASI 90, and PASI 100 responses were maintained throughout the extension study in both tildrakizumab treatment groups, regardless of whether subjects were responders at week 52. The mean change in PASI scores was maintained throughout the extension study in both treatment groups. Similarly, the mean percentage change in PASI scores was maintained over time in both treatment groups. The proportion of subjects with PGA score “disappearance” or “minimum,” resulting in a decrease of at least two grade points from baseline, was similar across most time points in the two tildrakizumab treatment groups and was maintained during the extension study. The proportion of subjects with any adverse experience or any device failure was very low over time among subjects treated with AI (≤0.5% and ≤1.6%, respectively).

[0582] Pharmacokinetic results: Based on available PK concentration data in extension 1 (up to week 244), the mean concentrations of tildrakizumab from week 76 to 244 were similar across all dose groups. The mean concentration in the 200 mg dose group was higher than in the 100 mg dose group, suggesting a dose-dependent increase in PK.

[0583] Immunogenic results Of the 725 ADA-evaluable subjects, 586 (80.8%) had definitive results overall. Of the 725 ADA-evaluable subjects, 491 (67.7%) were ADA-negative, 39 (5.4%) were ADA-positive untreated, and 56 (7.7%) were ADA-positive treated. The proportion of ADA-positive subjects was similar between the two treatment groups. The proportion of ADA-positive subjects treated was numerically higher in the tildrakizumab 100 mg group (35 [9.2%] subjects) compared to the tildrakizumab 200 mg group (21 [6.1%] subjects). The number of subjects with positive NAb positivity developed under treatment and PASI 75, 90, and 100 responses, as well as the number of subjects with positive NAb positivity developed under treatment and a PGA score of "disappeared" or "minimum" with at least a 2-grade point decrease from baseline, was ≤10 in the tildrakizumab 100 mg group and ≤3 in the tildrakizumab 200 mg group at each time point during the extension study.

[0584] Safety Assessment - Brief Summary of Adverse Events A comprehensive summary of adverse events (AEs) reported during the extension trial is provided in Table 31, broken down by treatment group. [Table 31]

[0585] No significant difference in the overall frequency of adverse events was observed between the two treatment groups (321 patients [84.3%] in the tildrakizumab 100 mg group and 307 patients [88.0%] in the tildrakizumab 200 mg group).

[0586] The frequency of drug-related adverse events (AEs) (91 patients [23.9%] and 99 patients [28.4%]), single-action emergencies (SAEs) (87 patients [22.8%] and 79 patients [22.6%] in the tildrakizumab 100 mg group and tildrakizumab 200 mg group, respectively), and discontinuation due to any AE (16 patients [4.2%] and 13 patients [3.7%]) were similar between the two treatment groups. The frequency of serious drug-related AEs, discontinuation due to drug-related AEs, and serious drug-related AEs were also similar between the two treatment groups.

[0587] The overall frequency of adverse events (AEs) and drug-related AEs was higher in subjects treated with progression-free survival (PFS) compared to subjects treated with artificial intelligence (AI), while the overall frequency of single-action AEs (SAEs) was higher in subjects treated with AI compared to subjects treated with PFS.

[0588] The cumulative exposure-adjusted frequency of overall AEs and drug-related AEs was slightly higher in tildrakizumab 200 mg than in tildrakizumab 100 mg, while SAEs, serious drug-related AEs, and AEs leading to discontinuation were similar between the two tildrakizumab treatment groups in the baseline study.

[0589] Similar trends were observed for the 5-year cumulative exposure-adjusted frequency in the baseline and extension studies. The frequency of overall AEs and drug-related AEs gradually decreased with longer treatment durations (overall AEs: Year 1: 64.0%; Year 2: 56.7%; Year 3: 51.4%; Year 4: 39.2%; drug-related AEs: Year 1: 16.3%; Year 2: 12.3%; Year 3: 11.9%; Year 4: 6.7%) and were similar between the two treatment groups.

[0590] Most frequently reported adverse events The proportion of subjects with adverse events (AEs) due to status of care (SOC) was generally similar in both treatment groups, with the exception of ear and labyrinthine disorder SOCs, where the rate of AEs was higher in the tildrakizumab 100 mg group than in the tildrakizumab 200 mg group.

[0591] Overall, the most frequently reported adverse events (AEs) in SOCs were infections and parasitic SOCs (248 [65.1%] and 231 [66.2%] in the tildrakizumab 100 mg and 200 mg groups, respectively), with no significant differences between the two treatment groups. The most frequently reported AE in PTs was nasopharyngitis (150 [39.4%] and 132 [37.8%] in the tildrakizumab 100 mg and 200 mg groups, respectively).

[0592] No significant differences in AEs reported by SOC and PT were observed between subjects treated with PFS and those treated with AI during the extension study. The 5-year cumulative exposure-adjusted frequencies of AEs reported by SOC and PT were generally similar.

[0593] Drug-related adverse events A summary of drug-related adverse events reported during the extension trial is provided in Table 32, categorized by treatment group, SOC, and PT. [Table 32] TIFF2026518199000053.tif255166TIFF2026518199000054.tif255165TIFF2026518199000055.tif241168

[0594] No significant difference was observed in the overall frequency of drug-related adverse events (AEs) between the two treatment groups (91 [23.9%] and 99 [28.4%] subjects in the tildrakizumab 100 mg and tildrakizumab 200 mg groups, respectively). The most frequently reported drug-related AEs by SOC were infections and parasites (152 [20.8%] subjects overall; 67 [17.6%] subjects in the tildrakizumab 100 mg group and 85 [24.4%] subjects in the tildrakizumab 200 mg group). The most frequently reported drug-related AE was nasopharyngitis (92 [12.6%] subjects overall; 43 [11.3%] subjects in the tildrakizumab 100 mg group and 49 [14.0%] subjects in the tildrakizumab 200 mg group).

[0595] No significant differences in the frequency of drug-related adverse events (AEs) were observed between subjects treated with PFS and those treated with AI during the extension study. No notable differences were observed in the 5-year cumulative exposure-adjusted frequency of drug-related AEs in the two tildrakizumab groups, according to SOC and PT.

[0596] Analysis of death, other serious adverse events, and other clinically significant adverse events (discontinuation due to death, other serious adverse events, adverse events, and other particularly noteworthy adverse events) death Table 33 provides a list of SAEs (Severely Active Infections) that resulted in death during the extension study, broken down by subject. Deaths were reported in six subjects during the extension study (four subjects in the tildrakizumab 100 mg group and two subjects in the tildrakizumab 200 mg group). Of these, two subjects died due to complete suicide, one due to toxicity to various drugs, one due to acute myocardial infarction, one due to asphyxiation, and one subject (subject ID: 208347) due to an unknown cause. All deaths were considered unrelated to the study drug. [Table 33]

[0597] Other serious adverse events A summary of SAEs reported during the extension study is provided in Table 34. One or more SAEs were reported in 87 (22.8%) and 79 (22.6%) subjects in the tildrakizumab 100 mg group and the tildrakizumab 200 mg group, respectively. Overall, the frequency of SAEs due to SOC was low (<5%) and similar between the two treatment groups. The most frequently reported SAEs due to SOC were: infection and parasitic SOCs (14 [3.7%] and 11 [3.2%] subjects in the tildrakizumab 100 mg group and the tildrakizumab 200 mg group, respectively) and benign, malignant, and unspecified neoplasms (including cysts and polyps) SOCs (12 [3.1%] and 16 [4.6%] subjects in the tildrakizumab 100 mg group and the tildrakizumab 200 mg group, respectively). [Table 34] TIFF2026518199000058.tif255165TIFF2026518199000059.tif255165TIFF2026518199000060.tif255168

[0598] No significant differences in the frequency of SAEs were observed between subjects treated with PFS and those treated with AI during the extension study. Overall, the frequency of SAEs due to SOC was low (<3%), and the most frequently reported SAEs due to SOC were infectious and parasitic SOCs (12 [1.6%]) in subjects treated with PFS and benign, malignant, and unspecified neoplasms (including cysts and polyps) (20 [2.7%]) in subjects treated with AI. No significant differences in the 5-year exposure-adjusted frequency of exposure-adjusted summaries for subjects with SAEs were reported during the base study and extension study. SAEs were observed between the two tildrakizumab treatment groups.

[0599] A summary of serious drug-related adverse events (AEs) reported during the extension study is provided in Table 35. The overall frequency of serious drug-related AEs during the extension study was low (1.9%) and similar between treatment groups (8 patients [2.1%] in the tildrakizumab 100 mg group and 6 patients [1.7%] in the tildrakizumab 200 mg group). [Table 35]

[0600] A notable difference was observed between the two tildrakizumab treatment groups in the 5-year cumulative exposure-adjusted frequency of serious drug-related adverse events.

[0601] Discontinuation due to adverse events Adverse events leading to discontinuation of the test drug A summary of adverse events (AEs) leading to discontinuation of the study drug reported during the extension study is provided in Table 36 by treatment group, SOC, and PT. The frequency of AEs leading to discontinuation of the study drug was similar in the two treatment groups (29 patients [4.0%] overall, with 16 patients [4.2%] in the tildrakizumab 100 mg group and 13 patients [3.7%] in the tildrakizumab 200 mg group, respectively). [Table 36] TIFF2026518199000063.tif62167

[0602] No significant difference in the frequency of adverse events (AEs) leading to discontinuation of the study drug due to SOC was observed between subjects treated with PFS and subjects treated with AI during the extension study. A 5-year cumulative exposure-adjusted summary of subjects with AEs leading to discontinuation of the study drug.

[0603] Drug-related adverse events leading to discontinuation of the investigational drug The frequency of drug-related adverse events (AEs) leading to discontinuation of the study drug was similar in the two treatment groups (7 subjects overall [1.0%], with 4 subjects [1.0%] and 3 subjects [0.9%] in the tildrakizumab 100 mg and tildrakizumab 200 mg groups, respectively). A 5-year cumulative exposure-adjusted summary of subjects with drug-related AEs leading to discontinuation of the study drug is shown. No notable differences were observed between the two tildrakizumab treatment groups in the 5-year cumulative exposure-adjusted frequency of drug-related AEs leading to discontinuation of the study drug.

[0604] Other adverse events of particular note Tier 1 adverse events A comprehensive summary of Tier 1 adverse events reported during the extension trial is provided in Table 37, broken down by treatment group. [Table 37]

[0605] No significant differences were observed between the two treatment groups in the frequency of pre-identified Tier 1 adverse events (AEs). The most frequently reported Tier 1 AEs were severe infections (15 patients [3.9%] and 11 patients [3.2%] in the tildrakizumab 100 mg and tildrakizumab 200 mg groups, respectively), followed by malignancies (9 patients [2.4%] and 13 patients [3.7%] in the tildrakizumab 100 mg and 200 mg groups, respectively).

[0606] No significant difference in the frequency of Tier 1 adverse events (AEs) was observed between subjects who self-injected and those who did not at week 52 during the extension study. A 5-year cumulative exposure-adjusted summary of subjects with Tier 1 AEs during the base study and extension study did not reveal any difference in the adjusted frequency of Tier 1 AEs between the two tildrakizumab treatment groups.

[0607] Tier 2 adverse events A comprehensive summary of Tier 2 AEs reported during the extension study is provided in Table 38 by treatment group. The frequency of Tier 2 AEs or drug-related Tier 2 AEs was higher in the tildrakizumab 200 mg group (307 subjects [88.0%] and 99 subjects [28.4%], respectively) compared to the tildrakizumab 100 mg group (321 subjects [84.3%] and 91 subjects [23.9%], respectively). The frequency of Tier 2 AEs among subjects with ADA that developed under treatment was higher in the tildrakizumab 100 mg group (32 subjects [8.4%]) compared to the tildrakizumab 200 mg group (18 subjects [5.2%]). No significant differences in the frequency of pre-identified Tier 2 AEs were observed between the two treatment groups.

[0608] Across the two treatment groups, 84 patients (11.5%) with ADA reported arbitrary adverse events (AEs) (50 patients [6.8%] with ADA occurring under treatment and 34 patients [4.7%] with ADA occurring untreated, respectively), while 420 patients (57.5%) with negative ADA and 124 patients (17.0%) with uncertain ADA also reported arbitrary AEs. No correlation was observed between the incidence of ADA and the frequency of AEs.

[0609] A 5-year cumulative exposure-adjusted summary of subjects with Tier 2 AEs during the base and extension studies did not reveal any significant differences in the 5-year cumulative exposure-adjusted frequency of Tier 2 AEs between the two tildrakizumab treatment groups. [Table 38]

[0610] Adverse events in subjects with anti-drug antibodies A summary of adverse events (AEs) reported in subjects with ADA that developed under treatment is provided in Table 39 by treatment group. Of the 56 subjects with ADA that developed under treatment during the extension study, 50 subjects (89.3%) reported one or more AEs (32 subjects [91.4%] in the tildrakizumab 100 mg group and 18 subjects [85.7%] in the tildrakizumab 200 mg group). [Table 39] TIFF2026518199000067.tif255167TIFF2026518199000068.tif255168TIFF2026518199000069.tif255166TIFF2026518199000070.tif196168

[0611] In subjects with ADA that developed under treatment, the most frequently reported adverse events (AEs) by SOC were infection and parasitic SOC (21 subjects [60.0%] and 12 subjects [57.1%] in the tildrakizumab 100 mg group and tildrakizumab 200 mg group, respectively). The most frequently reported AE by PT was nasopharyngitis (12 subjects [34.3%] and 5 subjects [23.8%] in the tildrakizumab 100 mg group and tildrakizumab 200 mg group, respectively). Compared to subjects with ADA that developed under treatment, SOC-mediated AEs that occurred more than ≥5 percentage points more frequently were respiratory, thoracic, and mediastinal disorders (25.0% vs. 17.3%) and neurological disorders (23.2% vs. 16.8%).

[0612] The most frequently reported adverse events (AEs) (≥10%) by PT in patients with ADA that developed under treatment were nasopharyngitis (30.4%), followed by upper respiratory tract infection (16.1%), diarrhea (14.3%), arthritis (14.3%), headache (14.3%), bronchitis (12.5%), and hypertension (10.7%).

[0613] PT-induced adverse events reported with a frequency ≥5 percentage points higher in subjects with ADA that developed under treatment compared to subjects in ASaT were headache (14.3% vs. 4.8%), diarrhea (14.3% vs. 6.3%), upper respiratory tract infection (16.1% vs. 9.5%), and bronchitis (12.5% ​​vs. 7.0%).

[0614] Based on 5-year cumulative exposure-adjusted summaries of adverse events (AEs) reported in subjects with ADA that developed under treatment and in subjects with ADA that developed without treatment, no significant differences were found between the two tildrakizumab treatment groups in the 5-year exposure-adjusted frequency of AEs reported in subjects with ADA that developed under treatment.

[0615] Adverse events in subjects with negative / indeterminate anti-drug antibody results. In subjects with ADA-positive symptoms that developed under treatment (Table 41), the following SOC-related adverse events occurred at a frequency ≥ 5 percentage points higher than in subjects with ADA-negative symptoms: respiratory, chest, and mediastinal disorders (25% vs. 16.3%); gastrointestinal disorders (26.8% vs. 20.8%); neurological disorders (23.2% vs. 17.3%); vascular disorders (19.6% vs. 13.8%); and research (16.1% vs. 10.6%).

[0616] In subjects with ADA that developed under treatment (Table 41), the following PT-induced adverse events were reported with a frequency ≥ 5 percentage points higher than in subjects with ADA negativity: headache (14.3% vs. 4.5%), diarrhea (14.3% vs. 4.9%), upper respiratory tract infection (16.1% vs. 8.8%), and bronchitis (12.5% ​​vs. 6.5%).

[0617] No significant differences in AEs reported by SOC and PT were observed among subjects who were negative, subjects with uncertain ADA status, and subjects with ASaT status.

[0618] A five-year cumulative exposure-adjusted summary of reported adverse events (AEs) in subjects with ADA-negative or indeterminate status is provided by treatment group in the base and extension studies. Notable differences were not observed in the five-year cumulative exposure-adjusted frequency of AEs by SOC between the two tildrakizumab groups in subjects with ADA-negative status. Notable differences were also not observed in the five-year cumulative exposure-adjusted frequency of AEs by SOC between the two tildrakizumab groups in subjects with ADA indeterminate status.

[0619] Confirmed composite cardiovascular events Table 40 provides an overall summary of the composite decision CV events confirmed during the extension study. The overall frequency of confirmed composite decision CV events was low (19 patients [2.6%]) and similar between the two treatment groups (9 patients [2.4%] in the tildrakizumab 100 mg group and 10 patients [2.9%] in the tildrakizumab 200 mg group).

[0620] No significant difference was observed between the two treatment groups in the frequency of confirmed composite CV events. [Table 40]

[0621] A 5-year cumulative exposure-adjusted overall summary of confirmed composite decision CV events during the extension study did not reveal any differences between the two tildrakizumab treatment groups due to a small number of subjects with confirmed composite decision CV events.

[0622] Confirmed cardiovascular events A comprehensive summary of the definitive CV events identified during the extended trial is provided in Table 41.

[0623] The overall frequency of confirmed diagnostic cardiovascular events was relatively low (21 patients [2.9%]) and similar in the two treatment groups (10 patients [2.6%] in the tildrakizumab 100 mg group and 11 patients [3.2%] in the tildrakizumab 200 mg group).

[0624] The frequency of acute myocardial infarction and coronary artery regeneration was numerically higher in the tildrakizumab 200 mg group (7 patients [2.0%] and 6 patients [1.7%], respectively) compared to the tildrakizumab 100 mg group (4 patients [1.0%] and 1 patient [0.3%], respectively). Aside from this, the frequency of confirmed definitive CV events was similar between the two treatment groups. [Table 41]

[0625] A 5-year cumulative exposure-adjusted overall summary of confirmed critical cardiovascular events during the baseline and extension studies did not reveal any meaningful differences between the two tildrakizumab treatment groups.

[0626] Clinical laboratory values ​​over time Overall, the mean changes from baseline in each laboratory parameter were small, and there was no change in the clinical significance of the mean laboratory values ​​over time. No significant differences in the mean change from baseline in clinical laboratory values ​​were observed between the two treatment groups.

[0627] electro-cardiogram Overall, the mean change from baseline in ECG...

Claims

1. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris in patients, wherein hum13B8-b is: (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

2. The pharmaceutical composition according to claim 1, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

3. The pharmaceutical composition lasts for at least about 64 weeks, at least about 76 weeks, at least about 88 weeks, at least about 100 weeks, at least about 112 weeks, at least about 124 weeks, at least about 136 weeks, at least about 148 weeks, at least about 160 weeks, at least about 172 weeks, at least about 184 weeks, at least about 196 weeks, at least about 208 weeks, at least about 220 weeks, at least about 232 weeks, and at least about 244 weeks. The pharmaceutical composition according to claim 1, administered to the patient over a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

4. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is administered to the patient approximately every 12 weeks.

5. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is administered subcutaneously to the patient.

6. The pharmaceutical composition according to claim 5, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.

7. The pharmaceutical composition according to claim 6, wherein the pharmaceutical composition is administered to the patient using an auto-injector or a pre-filled syringe.

8. The pharmaceutical composition according to claim 1, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient.

9. The pharmaceutical composition according to claim 1, wherein the dosage of the pharmaceutical composition contains 100 mg or 200 mg of hum13B8-b.

10. The pharmaceutical composition according to claim 9, wherein the dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

11. The pharmaceutical composition according to claim 9, wherein the dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

12. The pharmaceutical composition according to claim 1, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

13. The pharmaceutical composition according to claim 12, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition are the same.

14. The pharmaceutical composition according to claim 12, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition are different.

15. The pharmaceutical composition according to claim 12, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

16. The pharmaceutical composition according to claim 12, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

17. The pharmaceutical composition according to claim 12, wherein the subsequent dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

18. The pharmaceutical composition according to claim 12, wherein the subsequent dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

19. The pharmaceutical composition according to claim 13, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition each contain 100 mg of hum13B8-b.

20. The pharmaceutical composition according to claim 13, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition each contain 200 mg of hum13B8-b.

21. The pharmaceutical composition according to claim 14, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b, and the subsequent dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

22. The pharmaceutical composition according to claim 14, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b, and the subsequent dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

23. The subsequent dose of the pharmaceutical composition is administered every 12 weeks for at least 64 weeks, at least 76 weeks, at least 88 weeks, at least 100 weeks, at least 112 weeks, at least 124 weeks, at least 136 weeks, at least 148 weeks, at least 160 weeks, at least 172 weeks, at least 184 weeks, at least 196 weeks, at least 208 weeks, at least 220 weeks, at least 232 weeks, and so on. The pharmaceutical composition according to claim 12, administered for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

24. The pharmaceutical composition according to claim 1, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in about week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

25. The pharmaceutical composition according to claim 24, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition are the same.

26. The pharmaceutical composition according to claim 25, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition each contain 100 mg of humB138-b.

27. The pharmaceutical composition according to claim 25, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition each contain 200 mg of hum13B8-b.

28. The subsequent dose of the pharmaceutical composition is administered every 12 weeks for at least 64 weeks, at least 76 weeks, at least 88 weeks, at least 100 weeks, at least 112 weeks, at least 124 weeks, at least 136 weeks, at least 148 weeks, at least 160 weeks, at least 172 weeks, at least 184 weeks, at least 196 weeks, at least 208 weeks, at least 220 weeks, at least 232 weeks, and so on. The pharmaceutical composition according to claim 24, administered for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

29. The pharmaceutical composition according to claim 1, wherein administration of the pharmaceutical composition causes the patient to maintain a physician's overall assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for at least about 60 weeks.

30. By administering the aforementioned pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least approximately 256 weeks The pharmaceutical composition according to claim 29, wherein the patient maintains a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

31. The pharmaceutical composition according to claim 1, wherein administration of the pharmaceutical composition causes the patient to maintain at least a 50% reduction in psoriasis area and severity index (PASI 50) for at least about 60 weeks.

32. By administering the aforementioned pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks The pharmaceutical composition according to claim 31, wherein the patient maintains at least a 50% reduction in the psoriasis area and severity index (PASI 50) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

33. The pharmaceutical composition according to claim 1, wherein administration of the pharmaceutical composition causes the patient to maintain at least a 75% reduction (PASI 75) in the psoriasis area and severity index for at least about 60 weeks.

34. By administering the aforementioned pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks The pharmaceutical composition according to claim 33, wherein the patient maintains at least a 75% reduction (PASI 75) in the psoriasis area and severity index for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

35. The pharmaceutical composition according to claim 1, wherein administration of the pharmaceutical composition causes the patient to maintain at least a 90% reduction (PASI 90) in the psoriasis area and severity index for at least about 60 weeks.

36. By administering the aforementioned pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks The pharmaceutical composition according to claim 35, wherein the patient maintains at least a 90% reduction (PASI 90) in the psoriasis area and severity index for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

37. The pharmaceutical composition according to claim 1, wherein administration of the pharmaceutical composition causes the patient to maintain a 100% reduction in the psoriasis area and severity index (PASI 100) for at least about 60 weeks.

38. By administering the aforementioned pharmaceutical composition, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The pharmaceutical composition according to claim 37, wherein the patient maintains a 100% reduction in the psoriasis area and severity index (PASI 100) for a period of time up to, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks.

39. The pharmaceutical composition according to claim 1, wherein, upon administration of the pharmaceutical composition, the patient does not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least about 60 weeks compared to treatment for about 52 weeks.

40. By administering the aforementioned pharmaceutical composition, compared to treatment lasting up to approximately 52 weeks, the treatment duration is at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, and at least approximately 232 weeks. The pharmaceutical composition according to claim 39, wherein the patient does not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

41. The pharmaceutical composition according to claim 1, wherein the patient has a reduced risk of cardiac adverse events for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) a pharmaceutical composition of an anti-IL-23p19 antibody other than hum13B8-b, or (b) a pharmaceutical composition of an anti-IL-17 antibody.

42. The pharmaceutical composition according to claim 41, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

43. The administration of the pharmaceutical composition reduces the risk of cardiac adverse events compared to treatment with (a) a pharmaceutical composition of an anti-IL-23p19 antibody other than hum13B8-b, or (b) a pharmaceutical composition of an anti-IL-17 antibody, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, and at least approximately 208 weeks. The pharmaceutical composition according to claim 41, which is reduced compared to treatment lasting up to approximately 52 weeks, each lasting up to approximately 220 weeks, at least up to approximately 232 weeks, at least up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

44. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, in patients with psoriasis vulgaris, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

45. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

46. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

47. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

48. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A pharmaceutical composition comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2; and the pharmaceutical composition being administered to the patient for at least about 60 weeks.

49. The pharmaceutical composition according to any one of claims 44 to 48, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

50. The pharmaceutical composition lasts for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The pharmaceutical composition according to any one of claims 44 to 48, which is administered to the patient for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

51. The pharmaceutical composition according to any one of claims 44 to 48, wherein the pharmaceutical composition is administered to the patient approximately every 12 weeks.

52. The pharmaceutical composition according to any one of claims 44 to 48, wherein the pharmaceutical composition is administered subcutaneously to the patient.

53. The pharmaceutical composition according to claim 52, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.

54. The pharmaceutical composition according to claim 53, wherein the pharmaceutical composition is administered to the patient using an auto-injector or a pre-filled syringe.

55. The pharmaceutical composition according to any one of claims 44 to 48, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient.

56. The pharmaceutical composition according to any one of claims 44 to 48, wherein the dose of the pharmaceutical composition comprises 100 mg or 200 mg of hum13B8-b.

57. The pharmaceutical composition according to claim 56, wherein the dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

58. The pharmaceutical composition according to claim 56, wherein the dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

59. The pharmaceutical composition according to any one of claims 45 to 48, wherein an initial dose of the pharmaceutical composition is administered to the patient in week 0, and subsequent doses of the pharmaceutical composition are administered to the patient approximately every 12 weeks thereafter.

60. The pharmaceutical composition according to claim 59, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition are the same.

61. The pharmaceutical composition according to claim 59, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition are different.

62. The pharmaceutical composition according to claim 59, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

63. The pharmaceutical composition according to claim 59, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

64. The pharmaceutical composition according to claim 59, wherein the subsequent dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

65. The pharmaceutical composition according to claim 59, wherein the subsequent dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

66. The pharmaceutical composition according to claim 60, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition each contain 100 mg of hum13B8-b.

67. The pharmaceutical composition according to claim 60, wherein the initial dose of the pharmaceutical composition and the subsequent dose of the pharmaceutical composition each contain 200 mg of hum13B8-b.

68. The pharmaceutical composition according to claim 61, wherein the initial dose of the pharmaceutical composition contains 100 mg of hum13B8-b, and the subsequent dose of the pharmaceutical composition contains 200 mg of hum13B8-b.

69. The pharmaceutical composition according to claim 61, wherein the initial dose of the pharmaceutical composition contains 200 mg of hum13B8-b, and the subsequent dose of the pharmaceutical composition contains 100 mg of hum13B8-b.

70. The subsequent dose of the pharmaceutical composition is administered every 12 weeks for at least 64 weeks, at least 76 weeks, at least 88 weeks, at least 100 weeks, at least 112 weeks, at least 124 weeks, at least 136 weeks, at least 148 weeks, at least 160 weeks, at least 172 weeks, at least 184 weeks, at least 196 weeks, at least 208 weeks, at least 220 weeks, at least 232 weeks, and so on. The pharmaceutical composition according to claim 59, administered for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

71. The pharmaceutical composition according to any one of claims 44 to 48, wherein the initial dose of the pharmaceutical composition is administered to the patient in week 0, the second dose of the pharmaceutical composition is administered to the patient in about week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

72. The pharmaceutical composition according to claim 71, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition are the same.

73. The pharmaceutical composition according to claim 72, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition each contain 100 mg of hum13B8-b.

74. The pharmaceutical composition according to claim 72, wherein the initial dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent dose of the pharmaceutical composition each contain 200 mg of hum13B8-b.

75. The subsequent dose of the pharmaceutical composition is administered every 12 weeks for at least 64 weeks, at least 76 weeks, at least 88 weeks, at least 100 weeks, at least 112 weeks, at least 124 weeks, at least 136 weeks, at least 148 weeks, at least 160 weeks, at least 172 weeks, at least 184 weeks, at least 196 weeks, at least 208 weeks, at least 220 weeks, at least 232 weeks, and so on. The pharmaceutical composition according to claim 71, administered for at least approximately 244 weeks, at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

76. A method for treating psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

77. The method according to claim 76, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

78. hum13B8-b lasts for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 24 The method according to claim 76, wherein the patient is administered the drug for a period of up to four weeks, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks.

79. The method according to claim 76, wherein hum13B8-b is administered to the patient approximately every 12 weeks.

80. The method according to claim 80, wherein hum13B8-b is administered subcutaneously to the patient.

81. The method according to claim 80, wherein hum13B8-b is administered to the patient by subcutaneous injection.

82. The method according to claim 81, wherein hum13B8-b is administered to the patient using an auto-injector or a pre-filled syringe.

83. The method according to claim 76, wherein a therapeutically effective amount of hum13B8-b is administered to the patient.

84. The method according to claim 76, wherein 100 mg or 200 mg of hum13B8-b is administered to the patient.

85. The method according to claim 84, wherein 100 mg of hum13B8-b is administered to the patient.

86. The method according to claim 84, wherein 200 mg of hum13B8-b is administered to the patient.

87. The method according to claim 76, wherein an initial dose of hum13B8-b is administered to the patient in week 0, and subsequent doses of hum13B8-b are administered to the patient approximately every 12 weeks thereafter.

88. The method according to claim 87, wherein the initial dose and the subsequent dose are the same.

89. The method according to claim 87, wherein the initial dose and the subsequent dose are different.

90. The method according to claim 87, wherein the initial dose is 100 mg.

91. The method according to claim 87, wherein the initial dose is 200 mg.

92. The method according to claim 87, wherein the subsequent dose is 100 mg.

93. The method according to claim 87, wherein the subsequent dose is 200 mg.

94. The method according to claim 88, wherein the initial dose and the subsequent dose are 100 mg.

95. The method according to claim 88, wherein the initial dose and the subsequent dose are 200 mg.

96. The method according to claim 89, wherein the initial dose is 100 mg and the subsequent dose is 200 mg.

97. The method according to claim 89, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

98. The aforementioned subsequent dose is administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to claim 87, wherein the drug is administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

99. The method according to claim 76, wherein an initial dose of hum13B8-b is administered to the patient in week 0, a second dose of hum13B8-b is administered to the patient in approximately week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter.

100. The method according to claim 99, wherein the initial dose, the second dose, and the subsequent dose are the same.

101. The method according to claim 100, wherein the initial dose, the second dose, and the subsequent dose are 100 mg.

102. The method according to claim 100, wherein the initial dose, the second dose, and the subsequent dose are 200 mg.

103. The aforementioned subsequent dose is administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to claim 99, wherein the drug is administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

104. The method according to claim 76, wherein administration of hum13B8-b causes the patient to maintain a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for at least about 60 weeks.

105. Administration of hum13B8-b can be used for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, at least approximately 244 weeks, and at least approximately 256 weeks. The method according to claim 104, wherein the patient maintains a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least 2 points from baseline, for at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

106. The method according to claim 76, wherein administration of hum13B8-b causes the patient to maintain at least a 50% reduction in the psoriasis area and severity index (PASI 50) for at least about 60 weeks.

107. Administration of hum13B8-b results in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to claim 106, wherein the patient maintains at least a 50% reduction in the psoriasis area and severity index (PASI 50) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

108. The method according to claim 76, wherein administration of hum13B8-b causes the patient to maintain at least a 75% reduction in the psoriasis area and severity index (PASI 75) for at least about 60 weeks.

109. Administration of hum13B8-b results in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method of claim 108, wherein the patient maintains at least a 75% reduction in the psoriasis area and severity index (PASI 75) for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

110. The method according to claim 76, wherein administration of hum13B8-b allows the patient to maintain at least a 90% reduction in the psoriasis area and severity index (PASI 90) for at least about 60 weeks.

111. Administration of hum13B8-b results in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to claim 110, wherein the patient maintains at least a 90% reduction in the psoriasis area and severity index (PASI 90) for at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

112. The method according to claim 76, wherein the patient maintains a 100% reduction in the psoriasis area and severity index (PASI 100) for at least about 60 weeks by administration of hum13B8-b.

113. Administration of hum13B8-b results in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to claim 112, wherein the patient maintains a 100% reduction in the psoriasis area and severity index (PASI 100) for up to weeks, at least up to about 256 weeks, at least up to about 268 weeks, at least up to about 280 weeks, at least up to about 292 weeks, at least up to about 304 weeks, at least up to about 316 weeks, at least up to about 328 weeks, at least up to about 340 weeks, at least up to about 352 weeks, at least up to about 364 weeks, at least up to about 384 weeks, at least up to about 396 weeks, at least up to about 408 weeks, or at least up to about 432 weeks.

114. The method according to claim 76, wherein, upon administration of hum13B8-b, the patient does not experience an increase in adverse events (AEs), drug-related AEs, severe adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs for at least up to about 60 weeks compared to treatment for up to about 52 weeks.

115. Administration of hum13B8-b resulted in at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to claim 114, wherein the patient does not experience an increase in adverse events (AEs), drug-related AEs, serious adverse events (SAEs), Tier 1 AEs, or Tier 2 AEs compared to treatment lasting up to approximately 52 weeks, for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

116. The method according to claim 76, wherein the patient's risk of cardiac adverse events is reduced for at least about 60 weeks compared to the risk of cardiac adverse events with treatment using (a) an anti-IL-23p19 antibody other than hum13B8-b, or (b) an anti-IL-17 antibody.

117. The method according to claim 116, wherein the cardiac adverse event is pericarditis, atrial fibrillation, or coronary artery disease.

118. Administration of hum13B8-b reduces the risk of cardiac adverse events compared to treatment with (a) an anti-IL-23p19 antibody other than hum13B8-b, or (b) an anti-IL-17 antibody, for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, and at least approximately 2 The method according to claim 116, which reduces the effect compared to treatment lasting up to 20 weeks, at least about 232 weeks, at least about 244 weeks, at least about 256 weeks, at least about 268 weeks, at least about 280 weeks, at least about 292 weeks, at least about 304 weeks, at least about 316 weeks, at least about 328 weeks, at least about 340 weeks, at least about 352 weeks, at least about 364 weeks, at least about 384 weeks, at least about 396 weeks, at least about 408 weeks, or at least about 432 weeks, compared to treatment lasting up to about 52 weeks.

119. A method for maintaining a physician's global assessment (PGA) score of "clear" or "nearly clear," with a decrease of at least two points from baseline, in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

120. A method for maintaining at least a 50% reduction in psoriasis area and severity index (PASI 50) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

121. A method for maintaining at least a 75% reduction in psoriasis area and severity index (PASI 75) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

122. A method for maintaining at least a 90% reduction in psoriasis area and severity index (PASI 90) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

123. A method for maintaining a 100% reduction in psoriasis area and severity index (PASI 100) in patients with psoriasis vulgaris, comprising administering the anti-IL-23p19 antibody hum13B8-b to patients in need thereof, wherein hum13B8-b is (i) A light chain polypeptide containing the amino acid sequence of SEQ ID NO: 1, and (ii) A method comprising a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 2, and hum13B8-b being administered to the patient for at least about 60 weeks.

124. The method according to any one of claims 119 to 123, wherein the psoriasis vulgaris is moderate to severe psoriasis vulgaris.

125. hum13B8-b lasts for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least approximately 244 weeks. The method according to any one of claims 119 to 123, wherein the patient is administered the drug for a period of at least approximately 256 weeks, at least approximately 268 weeks, at least approximately 280 weeks, at least approximately 292 weeks, at least approximately 304 weeks, at least approximately 316 weeks, at least approximately 328 weeks, at least approximately 340 weeks, at least approximately 352 weeks, at least approximately 364 weeks, at least approximately 384 weeks, at least approximately 396 weeks, at least approximately 408 weeks, or at least approximately 432 weeks.

126. The method according to any one of claims 119 to 123, wherein hum13B8-b is administered to the patient approximately every 12 weeks.

127. The method according to any one of claims 119 to 123, wherein hum13B8-b is administered subcutaneously to the patient.

128. The method according to claim 127, wherein hum13B8-b is administered to the patient by subcutaneous injection.

129. The method according to claim 128, wherein hum13B8-b is administered to the patient using an auto-injector or a pre-filled syringe.

130. The method according to any one of claims 119 to 123, wherein a therapeutically effective dose of hum13B8-b is administered to the patient.

131. The method according to any one of claims 119 to 123, wherein 100 mg or 200 mg of hum13B8-b is administered to the patient.

132. The method according to claim 131, wherein 100 mg of hum13B8-b is administered to the patient.

133. The method according to claim 131, wherein 200 mg of hum13B8-b is administered to the patient.

134. The method according to any one of claims 119 to 123, wherein an initial dose of hum13B8-b is administered to the patient in week 0, and subsequent doses of hum13B8-b are administered to the patient approximately every 12 weeks thereafter.

135. The method according to claim 134, wherein the initial dose and the subsequent dose are the same.

136. The method according to claim 134, wherein the initial dose and the subsequent dose are different.

137. The method according to claim 134, wherein the initial dose is 100 mg.

138. The method according to claim 134, wherein the initial dose is 200 mg.

139. The method according to claim 134, wherein the subsequent dose is 100 mg.

140. The method according to claim 134, wherein the subsequent dose is 200 mg.

141. The method according to claim 135, wherein the initial dose and the subsequent dose are 100 mg.

142. The method according to claim 135, wherein the initial dose and the subsequent dose are 200 mg.

143. The method according to claim 136, wherein the initial dose is 100 mg and the subsequent dose is 200 mg.

144. The method according to claim 136, wherein the initial dose is 200 mg and the subsequent dose is 100 mg.

145. The subsequent dose is administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to claim 134, wherein the drug is administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

146. The method according to any one of claims 119 to 123, wherein an initial dose of hum13B8-b is administered to the patient in week 0, a second dose of hum13B8-b is administered to the patient in week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter.

147. The method according to claim 146, wherein the initial dose, the second dose, and the subsequent dose are the same.

148. The method according to claim 147, wherein the initial dose, the second dose, and the subsequent dose are 100 mg.

149. The method according to claim 147, wherein the initial dose, the second dose, and the subsequent dose are 200 mg.

150. The subsequent dose is administered approximately every 12 weeks for at least approximately 64 weeks, at least approximately 76 weeks, at least approximately 88 weeks, at least approximately 100 weeks, at least approximately 112 weeks, at least approximately 124 weeks, at least approximately 136 weeks, at least approximately 148 weeks, at least approximately 160 weeks, at least approximately 172 weeks, at least approximately 184 weeks, at least approximately 196 weeks, at least approximately 208 weeks, at least approximately 220 weeks, at least approximately 232 weeks, and at least The method according to claim 146, wherein the drug is administered for a period of up to approximately 244 weeks, at least up to approximately 256 weeks, at least up to approximately 268 weeks, at least up to approximately 280 weeks, at least up to approximately 292 weeks, at least up to approximately 304 weeks, at least up to approximately 316 weeks, at least up to approximately 328 weeks, at least up to approximately 340 weeks, at least up to approximately 352 weeks, at least up to approximately 364 weeks, at least up to approximately 384 weeks, at least up to approximately 396 weeks, at least up to approximately 408 weeks, or at least up to approximately 432 weeks.

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