Methods and compositions for treating nail psoriasis

Abstract

The disclosure relates to methods of treating nail psoriasis in a subject comprising administering a therapeutically effective amount of an anti-IL-23p19 antibody hum13B8-b to the subject. The disclosure also relates to methods of improving one or more of total- modified Nail Psoriasis Severity Index (mNAPSI), Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score, total Nail Psoriasis Severity Index (NAPSI), nail pain numeric rating scale (NRS) score, Modified Nail Psoriasis Severity Index (mNAPSI), Nail Psoriasis Severity Index (NAPSI), Visual medical scale to evaluate nail psoriasis severity (ViSENPsO), or nail pain numeric rating scale (NRS) score in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23p19 antibody hum13B8-b to the subject. The disclosure further relates to methods of increasing Quality of Life (QoL) in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23p19 antibody hum13B8-b to the subject. The disclosure further relates to pharmaceutical compositions of an anti-IL-23p19 antibody hum13B8-b for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating nail psoriasis in a subject.

Description

METHODS AND COMPOSITIONS FOR TREATING NAIL PSORIASISCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of Indian Application No. 202321083256, filed on December 6, 2023, the disclosure of which is incorporated by reference herein in its entirety.SEQUENCE LISTING

[0002] This application contains a sequence listing which is submitted electronically and is hereby incorporated by reference in its entirety. The sequence listing submitted herewith is contained in the XML file created December 5, 2024 entitled "23-1517-WO_Sequence- Listing.xml" and is 8,461 bytes in size.FIELD OF THE DISCLOSURE

[0003] The disclosure relates to methods of treating nail psoriasis in a subject comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure also relates to methods of improving one or more of total- modified Nail Psoriasis Severity Index (mNAPSI), Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score, total Nail Psoriasis Severity Index (NAPSI), nail pain numeric rating scale (NRS) score, Modified Nail Psoriasis Severity Index (mNAPSI), Nail Psoriasis Severity Index (NAPSI), Visual medical scale to evaluate nail psoriasis severity (ViSENPsO), or nail pain numeric rating scale (NRS) score in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure further relates to methods of increasing Quality of Life (QoL) in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure further relates to pharmaceutical compositions of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for treating nail psoriasis in a subject.BACKGROUND

[0004] Psoriasis is a chronic inflammatory skin disorder that affects approximately 1% to 2% of people worldwide. Currently approved biological treatments for moderate to severe plaque psoriasis include tumor necrosis factor (TNF) antagonist agents, a p40 (interleukin [IL] 12 and IL 23) antagonist, pl9 (IL 23) antagonists, and IL-17 antagonist agents.

[0005] Recent studies have demonstrated that IL-23-dependent T-helper (Th) 17 cells control much of the inflammatory damage that is observed in psoriasis. Based on this rationale,several therapeutic anti-IL-23 antibodies were developed and entered into clinical studies. Tildrakizumab, an anti -IL 23pl9 antibody, demonstrates comparable efficacy in the treatment of psoriasis to other biological compounds in the IL-23 pathway. It has a favorable safety profile and convenient dosing at weeks 0, 4, and every 12 weeks after that.

[0006] Tildrakizumab was approved as ILUMYA™ in the United States for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and in Australia for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

[0007] Nail psoriasis occurs in approximately 50% of patients with plaque psoriasis and is associated with pain and discomfort, causing a significant burden to quality of life (QoL) and work function. Nail psoriasis affects the nail matrix and the nail bed. The clinical manifestations of psoriasis of the nail matrix include pitting (most common lesion), nail plate crumbling, and leukonychia, while clinical manifestations of psoriasis of the nail bed include the presence of oil-drop or salmon patch dyschromia, onycholysis, subungual hyperkeratosis, and splinter hemorrhages. Treatment options include topical agents, phototherapy, and / or systemic agents (conventional agents and biological treatments).

[0008] Biological therapies are indicated for the treatment of subjects with moderate to severe chronic plaque psoriasis who are candidates for phototherapy or systemic therapy. Currently approved biological treatments for moderate to severe plaque psoriasis include tumor necrosis factor(TNF) antagonist agents, z.e., etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®), and the p40 (IL- 12 and IL-23) antagonist ustekinumab (Stelara®). Despite the availability of treatment options for plaque psoriasis, nail lesions remain difficult to treat as patient satisfaction and compliance with topical therapy are known to be low. The use of topical therapy, typically the first line of treatment for plaque psoriasis, is often challenging because of the poor diffusion into the nail tissue.

[0009] In recent years, accumulating data have implicated the IL-23 / Thl7 pathway in psoriasis pathogenesis. Recent genome-wide association studies have identified psoriasis risk alleles around gene regions that encode IL-23 (IL23A, IL12B) and the IL-23 receptor (IL- 23R). Both pl9 and p40 sub-units of IL-23 are over-expressed in psoriatic skin lesions, while the unique p35 sub-unit of IL- 12 is not. Th 17 cells, and the cytokines they elaborate, are abundant in psoriasis lesions, where they exert pro-inflammatory and pro-acanthotic effects. Compelling evidence for the functional role of IL-23pl9 in psoriasis is demonstrated by a xenotransplant mouse model of psoriasis using AGR-129 mice wherein the administration of anti-human IL-23pl9 inhibited the development of psoriatic lesions comparable to anti-TNF-a blockers, the current benchmark in psoriasis treatment. It has been shown that disease improvement with anti-TNF-a therapy correlated with the rapid down-modulation of IL-23 and Th 17 cell products, and successful response to treatment was dependent on the inactivation of the IL-23 / Thl7 pathway. Thus, while the use of IL-12 / IL-23 p40 antagonists (e.g., ustekinumab and briakinumab) have been clinically validated in psoriasis, recent data suggest that the efficacy of these antagonists likely depends primarily, if not exclusively, on their ability to neutralize IL-23 rather than IL- 12. This provides the rationale for selectively targeting IL-23pl9 in subjects with nail psoriasis. Thus, there remains an unmet need for effective therapeutic options for nail psoriasis.SUMMARY

[0010] The disclosure relates to methods of treating nail psoriasis. The disclosure also relates to methods of improving indices of nail psoriasis via administration of a humanized IL-23pl9 IgGl / K antibody. The disclosure further relates to pharmaceutical compositions of an anti- IL-23pl9 antibody for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23pl9 antibody for the manufacture of a medicament for treating nail psoriasis in a subject.

[0011] More specifically, the disclosure relates to a method of treating nail psoriasis in a subject comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure also relates to a method of improving one or more of total-modified Nail Psoriasis Severity Index (mNAPSI), Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score, total Nail Psoriasis Severity Index (NAPSI), nail pain numeric rating scale (NRS) score, Modified Nail Psoriasis Severity Index (mNAPSI), Nail Psoriasis Severity Index (NAPSI), Visual medical scale to evaluate nail psoriasis severity (ViSENPsO), or nail pain numeric rating scale (NRS) score in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure further relates to a method of increasing Quality of Life (QoL) in a subject with nail psoriasis with by administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure further relates to pharmaceutical compositions of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for treating nail psoriasis in a subject.

[0012] Provided herein is a method of treating nail psoriasis in a subject in need thereof, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0013] Also provided herein is a method of improving one or more of: (a) total-modified Nail Psoriasis Severity Index (mNAPSI); (b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or (c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0014] Further provided herein is a method of improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0015] Further provided herein is a method of improving one or more of: (a) Modified Nail Psoriasis Severity Index (mNAPSI); (b) Nail Psoriasis Severity Index (NAPSI); (c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or (d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0016] Further provided herein is a method of improving one or more of: (a) Modified Nail Psoriasis Severity Index (mNAPSI); (b) Nail Psoriasis Severity Index (NAPSI); (c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or (d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0017] Further provided herein is a method of increasing Quality of Life (QoL) in a subject with nail psoriasis, the method comprising a therapeutically effective amount of an anti-IL- 23pl9 antibody huml3B8-b to the subject; wherein a first dose of a huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose is administered to the subject about 52 weeks after the first dose is administered to the subject;and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0018] Further provided herein is a pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in a subject; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0019] Further provided herein is a pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of: (a) total-modified Nail Psoriasis Severity Index (mNAPSI); (b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or (c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0020] Further provided herein is a pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose ofthe pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0021] Further provided herein is a pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of: (a) Modified Nail Psoriasis Severity Index (mNAPSI); (b) Nail Psoriasis Severity Index (NAPSI); (c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or (d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0022] Further provided herein is a pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for increasing Quality of Life (QoL) in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0023] Further provided herein is use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for treating nail psoriasis in a subject; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final doseof the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0024] Further provided herein is use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving one or more of: (a) total-modified Nail Psoriasis Severity Index (mNAPSI); (b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or (c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0025] Further provided herein is use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0026] Further provided herein is use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving one or more of: (a) Modified Nail Psoriasis Severity Index (mNAPSI); (b) Nail Psoriasis Severity Index (NAPSI); (c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or (d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent dosesof the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0027] Further provided herein is use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for increasing Quality of Life (QoL) in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0028] These and other features and advantages of the present disclosure will be more fully understood from the following detailed description taken together with the accompanying claims. It is noted that the scope of the claims is defined by the recitations therein and not by the specific discussion of features and advantages set forth in the present description.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0029] FIGURE 1 depicts a flowchart representing the overall study schema for the Tildrakizumab study.

[0030] FIGURE 2 depicts a photographic visual of the quadrants and evaluating different characteristics of the NAPSI evaluation.

[0031] FIGURE 3 depicts a visual schematic grading the degree of nail psoriasis.

[0032] FIGURE 4 depicts a sample Quality of Life Index (QOLI)

[0033] FIGURE 5 depicts a sample Quality of Life (QoL) questionnaire.DETAILED DESCRIPTION

[0034] The disclosure relates to methods of treating nail psoriasis. More specifically, the disclosure relates to methods of improving nail psoriasis as evidenced by improvements in clinically accepted measures of nail psoriasis. In particular, the disclosure relates to treating nail psoriasis as evidenced by improvements in a total-modified Nail Psoriasis Severity Index (mNAPSI), Scale to Evaluate Nail Psoriasis severity (ViSENPsO), total Nail PsoriasisSeverity Index (NAPSI), and / or a nail pain numeric rating scale (NRS) score. The disclosure further relates to pharmaceutical compositions of an anti-IL-23pl9 antibody for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23pl9 antibody for the manufacture of a medicament for treating nail psoriasis in a subject.

[0035] The disclosure relates to methods of treating nail psoriasis in a subject comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure also relates to methods of improving one or more of total- modified Nail Psoriasis Severity Index (mNAPSI), Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score, total Nail Psoriasis Severity Index (NAPSI), nail pain numeric rating scale (NRS) score, Modified Nail Psoriasis Severity Index (mNAPSI), Nail Psoriasis Severity Index (NAPSI), Visual medical scale to evaluate nail psoriasis severity (ViSENPsO), or nail pain numeric rating scale (NRS) score in a subject with nail psoriasis by administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject. The disclosure further relates to methods of increasing Quality of Life (QoL) in a subject with nail psoriasis with by administering a therapeutically effective amount of an anti-IL- 23pl9 antibody huml3B8-b to the subject. The disclosure further relates to pharmaceutical compositions of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in subject. The disclosure further relates to the use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for treating nail psoriasis in a subject.

[0036] As utilized in accordance with the present disclosure, unless otherwise indicated or defined, all technical and scientific terms used herein shall be understood to have the meaning commonly understood by a person skilled in the art to which this disclosure belongs. The following references provide one of skill with a general definition of many of the terms used in this disclosure: Singleton et al., Dictionary of Microbiology and Molecular Biology (2nd ed. 1994); The Cambridge Dictionary of Science and Technology (Walker ed., 1988); The Glossary of Genetics, 5th Ed., R. Rieger et al. (eds.), Springer Verlag (1991); and Hale & Marham, The Harper Collins Dictionary of Biology (1991). As used herein, the following terms have the meanings ascribed to them below, unless specified otherwise.

[0037] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. For example, the terms "a," "an," and "the," as used herein, are understood to be singular or plural unless the context clearly dictates otherwise. It should be understood that the terms "a" and "an," as used herein, refer to "one or more" of the enumerated components unless otherwise indicated or dictated by its context. The use of the alternative (e.g., "or") should be understood to mean either one, both, or any combinationthereof of the alternatives unless otherwise indicated. Thus, unless specifically stated or apparent from context, the term "or," as used herein, is understood to be inclusive.

[0038] The terms "comprises" and "comprising," as used herein, can have the meaning ascribed to them in U.S. patent law and can mean "includes," "including," "containing," "having," and the like. Thus, unless expressly specified otherwise, the terms "comprises" and "comprising," as used herein, indicate that further components or members may optionally be present in addition to the components or members of the list introduced by "comprising." The terms "consisting essentially of' or "consists essentially," as used herein, likewise have the meaning ascribed in U.S. patent law, and allow for the presence of more than that which is recited so long as basic or novel characteristics of that which is recited are not changed by the presence of more than that which is recited.

[0039] Any of the methods provided herein can be combined with one or more of any of the other methods provided herein. Any of the compositions provided herein can be combined with one or more of any of the other compositions provided herein. Any of the uses provided herein can be combined with one or more of any of the other uses provided herein.

[0040] In the present disclosure, any concentration range, percentage range, ratio range, or integer range is to be understood to include the value of any integer within the recited range and, when appropriate, fractions thereof (such as one tenth and one hundredth of an integer), unless otherwise indicated. Ranges provided herein are understood to be shorthand for all of the values within the range. For example, a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.

[0041] Unless specifically stated or apparent from context, the terms "about" and "approximately," as used herein, are understood as meaning within a range of normal tolerance in the art, for example within 2 standard deviations of the mean, or mean within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, z.e., the limitations of the measurement system. "About" can be understood as meaning within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.

[0042] It is noted that terms like "preferably," "commonly," and "typically" are not utilized herein to limit the scope of the claimed subject matter or to imply that certain features arecritical, essential, or even important to the structure or function of the claimed subject matter. Rather, these terms are merely intended to highlight alternative or additional features that can or cannot be utilized in a particular embodiment of the present disclosure.

[0043] For the purposes of describing and defining the present disclosure it is noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty that can be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree by which a quantitative representation can vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.IL-23pl9 Antibody

[0044] In some embodiments, the disclosure provides a method of improving a total- modified Nail Psoriasis Severity Index (mNAPSI) in a subject with nail psoriasis, the method comprising administering an initial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4); and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose. In some embodiments, the disclosure provides a pharmaceutical composition of an anti-IL-23pl9 antibody for the treatment of nail psoriasis in subject. In some embodiments, the disclosure provides the use of an anti-IL-23pl9 antibody for the manufacture of a medicament for treating nail psoriasis in a subject. In particular embodiments, the anti-IL-23pl9 antibody huml3B8-b is tildrakizumab.

[0045] The term "tildrakizumab," as used herein, refers to a humanized anti-IL-23pl9 monoclonal antibody, also known as SCH 900222 or MK-3222. Tildrakizumab is a high- affinity (297 picomolar [pM]) humanized immunoglobulin Gl / kappa (IgG 1 / K) antibody that specifically binds to the pl 9 protein of the IL-23 heterodimer but does not bind human IL- 12 (IL-12 / 23p40 and IL12p35 heterodimer) or human IL-12 / 23p40.

[0046] Clinically useful IL-12 / IL-23 p40 antagonists to-date derive benefits in psoriasis by targeting IL-23 rather than IL- 12. With this knowledge the inventors of the current disclosure utilized tildrakizumab to target only IL-23pl9 (SN 08197) but not human IL-12 (IL-12p40 and p35 heterodimer) or human p40 in the treatment of nail psoriasis. As such, the use of tildrakizumab is a novel approach in the treatment of nail psoriasis.

[0047] In particular embodiments, the anti-IL-23pl9 antibody huml3B8-b (tildrakizumab) comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2, and which is disclosed in U.S. Patent Nos. 8,404,813 and 8,293,883, the disclosures of each of which are hereby incorporated by reference in their entireties. In other embodiments, the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof comprises a heavy chain variable domain and a light chain variable domain, wherein the heavy chain variable domain comprises CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 3-5, and wherein the light chain variable domain comprises CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 6-8.

[0048] Huml3B8-b Light Chain (SEQ ID NO: 1)DIQMTQSPSSLSASVGDRVTITCRTSENIYSYLAWYQQKPGKAPKLLIYNAKTLAEGVPSRF SGSGSGTDFTLTISSLQPEDFATYYCQHHYGIPFTFGQGTKVEIKRTVAAPSVFIFPPSDEQ LKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADY EKHKVYACEVTHQGLSSPVTKSFNRGEC

[0049] Huml3B8-b Heavy Chain (SEQ ID NO: 2)QVQLVQSGAEVKKPGASVKVSCKASGYI FITYWMTWVRQAPGQGLEWMGQI FPASGSADYNE KFEGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARGGGGFAYWGQGTLVTVSSASTKGPSV FPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVT VPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKD TLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQ DWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFY PSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNH YTQKSLSLSPGK

[0050] Huml3B8-b Heavy Chain CDR1 (SEQ ID NO: 3)GYIFITYWMT

[0051] Huml3B8-b Heavy Chain CDR2 (SEQ ID NO: 4)QI FPASGSADYNEKFE

[0052] Huml3B8-b Heavy Chain CDR3 (SEQ ID NO: 5)GGGGFAY

[0053] Huml3B8-b Light Chain CDR1 (SEQ ID NO: 6)RTSENIYSYLA

[0054] Huml3B8-b Light Chain CDR2 (SEQ ID NO: 7)NAKTLAE

[0055] Huml3B8-b Light Chain CDR3 (SEQ ID NO: 8)QHHYGIPFT

[0056] In some embodiments, the anti-IL-23pl9 antibody tildrakizumab can refer to ILUMYA®. In some embodiments, tildrakizumab is formulated in a 1 m single-dose prefdled syringe containing 100 mg of tildrakizumab (z.e., 100 mg / mL). In some embodiments, ILUMYA® (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA® is supplied in a single-dose prefdled syringe with a glass barrel and 29-gauge fixed, 1 / 2-inch needle. In one embodiment, the subcutaneous administration is in the abdominal region.

[0057] In some embodiments, tildrakizumab can be formulated in: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and / or sucrose, in water for injection, with a pH of 5.7-6.3. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose prefilled syringe containing 100 mg of tildrakizumab-asmn formulated in: 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.

[0058] The anti-IL-23pl9 antibody can be administered in a range of doses from 5-250 mg. In some embodiments of the current disclosure about 5 mg, about 10, mg, about 15, mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75, mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 mg, about 190 mg, about 195 mg, about 200 mg, about 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, or about 250 mg. In some embodiments of the current disclosure 25 mg, 50 mg, 75 mg or 100 mg of the anti-IL-23pl9 antibody is administered. In one embodiment of the current disclosure 100 mg of the anti-IL-23pl9 antibody is administered. More particularly, in one embodiment 100 mg of tildrakizumab is administered.

[0059] As used herein, the term "subject" and "patient" are interchangeable. In some embodiments, subjects and / or patients are mammals.

[0060] A "disorder" is any condition that would benefit from treatment using the antibodies of the disclosure. "Disorder" and "condition" are used interchangeably herein and includechronic and acute disorders or diseases, including those pathological conditions that predispose a subject or patient to the disorder in question.

[0061] The terms "treatment" or "treat" as used herein refer to both therapeutic treatment and prophylactic or preventative measures. Those in need of treatment include subjects or patients having nail psoriasis as well as those prone to have nail psoriasis or those in which nail psoriasis is to be prevented.

[0062] The terms "administration" or "administering" as used herein refer to providing, contacting, and / or delivering an antibody or fragment thereof by any appropriate route to achieve the desired effect. Administration may include, but is not limited to, oral, sublingual, parenteral (e.g., intravenous, subcutaneous, intracutaneous, intramuscular, intraarticular, intraarterial, intrasynovial, intrastemal, intrathecal, intralesional, or intracranial injection), transdermal, topical, buccal, rectal, vaginal, nasal, ophthalmic, via inhalation, and implants. In an embodiment, administration is subcutaneous via a pre-fdled syringe (PFS).

[0063] In some embodiments, the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof is administered every two weeks, every four weeks, every six weeks, every eight weeks, every ten weeks, or every twelve weeks.

[0064] As used herein, the term "Week 0" refers to the first day the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof is administered.

[0065] In some embodiments, the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof is administered over a two week treatment period, over a four week treatment period, over a six week treatment period, over an eight week treatment period, over a twelve week treatment period, over a sixteen week treatment period, over a twenty week treatment period, over a twenty -four week treatment period, over a twenty-eight week treatment period, over a thirty-two week treatment period, over a thirty-six week treatment period, over a forty-eight week treatment period, over a fifty -two week treatment period, over a sixty week treatment period, over a seventy -two week treatment period, or over a one year or more treatment period.

[0066] The therapy dose or therapeutically effective amount of the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof will vary depending, in part, upon the size (body weight, body surface, or organ size) and condition (the age and general health) of the subject or patient. In some embodiments, the subject or patient is administered one or more doses of the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof, wherein the dose is about 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 first dose, the second dose and thesubsequent dose of the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof are the same. In some embodiments, the first dose, the second dose, and the subsequent dose of the anti-IL-23pl9 antibody huml3B8-b or an antigen-binding fragment thereof are different. In some embodiments, the first dose is 100 mg. In some embodiments, the first 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 first dose, the second dose, and the subsequent dose are 100 mg. In some embodiments, the first dose, the second dose, and the subsequent dose are 200 mg. In some embodiments, the first dose, the second dose, and the subsequent dose contain 100 mg huml3B8-b. In some embodiments, the first dose, the second dose, and the subsequent dose contain 200 mg huml3B8-b.

[0067] The term "therapeutically effective amount" as applied to dose or amount refers to the quantity of a compound or pharmaceutical composition that is sufficient to result in a desired effect upon administration to a subject in need thereof. As used herein with respect to the pharmaceutical compositions comprising the anti-IL-23pl9 antibody huml3B8-b (z.e., tildrakizumab), the term "therapeutically effective amount" also refers to the dose of a compound or pharmaceutical composition that is sufficient to produce an effective response upon administration to a subject. In some embodiments, a therapeutically effective amount of the anti-IL-23pl9 antibody huml3B8-b (z.e., tildrakizumab) refers to a dose 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, a therapeutically effective amount of the anti-IL-23pl9 antibody huml3B8-b (z.e., tildrakizumab) is a dose of 100 mg. In some embodiments, a therapeutically effective amount of the anti-IL-23pl9 antibody huml3B8-b (z.e., tildrakizumab) is a dose of 100 mg at weeks 0, 4, and every 12 weeks thereafter.Efficacy Assessments

[0068] Efficacy assessments serve as objective measures of nail psoriasis severity and improvements in nail psoriasis following treatment. a. Nail Psoriasis Severity Index (NAPSI) & modified NAPSI (mNAPSI)

[0069] The Nail Psoriasis Severity Index (NAPSI) is a numeric, reproducible, objective, simple tool for the evaluation of nail psoriasis. The scale is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. In one embodiment, the disclosure provides a method of improving total Nail Psoriasis Severity Index (NAPSI) in a subject with nail psoriasis, the method comprising administering aninitial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4), and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0070] A modified version (mNAPSI) was developed to enhance the face validity and feasibility of the NAPSI. The mNAPSI measures onycholysis, pitting, nail plate crumbling, leukonychia, splinter hemorrhage, hyperkeratosis, and red spots in the lunula and score as indicated in Table 1. The cumulative scores of the mNAPSI range from 0-130 for all nails of a given type. able 1. mNAPSI Measures and Scoring

[0071] In one embodiment, the disclosure provides a method of improving a total-modified Nail Psoriasis Severity Index (mNAPSI) in a subject with nail psoriasis, the method comprising: administering an initial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0), (b) administering a second dose of the humanized IL-23pl9IgGl / K antibody to the subject at about four weeks after the initial dose (week 4), and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0072] The NAPSI and mNAPSI are used to assess nail pitting; nail onycholysis and oil-drop dyschromia; nail crumbling; nail leukonychia, splinter hemorrhages, hyperkeratosis, red spots in the lunula.

[0073] The term "NAPSI," as used herein, refers to the total matrix score of all involved nails. More particularly, each nail has a matrix score (0-4) and a nail bed score (0-4), and the total nail score is the sum of those 2 individual scores (0-8) sum of the total score of all involved fingernails is the total NAPSI score for that patient at that time point. A score is 0 if the items are not present, 1 if they are present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail as indicated in Table 2. The score for a single nail range from 0-8 and the score for all nails is added with a score range from 0-80. An example of nail quadrants is shown in Figure 2.Table 2. Nail Psoriasis Severity Index

[0074] The mNAPSI and NAPSI assessment scores are compared and the total scores indicative of improvement, deterioration, or no change in nail psoriasis. The mNAPSI andNAPSI can be assessed at any interval from about 2 to about 52 weeks. For example, nail psoriasis can be assessed at about week 0, at about week 2, at about week 4, at about week 6, at about week 8, at about week 10, at about week 12, at about week 14, at about week 16, at about week 18, at about week 20, at about week 22, at about week 24, at about week 26, at about week 28, at about week 30, at about week 32, at about week 34, at about week 36, at about week 38, at about week 40, at about week 42, at about week 44, at about week 46, at about week 48, at about week 50, and about week 52. In one embodiment of the current disclosure, the mNAPSI and NAPSI are assessed at week 0, week 4, week 16 ,week 28, week 40, and week 52. The scores at each timepoint are compared for improvements, deterioration, or no change in nail psoriasis.

[0075] The term "mNAPSI 75," as used herein, refers to a 75% improvement in total- mNAPSI scores of a subject as compared at two time points. The score is indicative of treatment efficacy. In one embodiment of the current disclosure the total-mNAPSI score at week 0 is compared to the same score at week 28 and the number of subjects achieving a mNAPSI 75 reported. The total-mNAPSI score can be assessed at any two timepoints from the timepoints disclosed herein. The total-NAPSI score can similarly be assessed.

[0076] The term "mNAPSI 90," as used herein, refers to a 90% improvement in total- mNAPSI scores of a subject as compared at two time points. The score is indicative of treatment efficacy. In one embodiment of the current disclosure the total-mNAPSI score at week 0 is compared to the same score at week 28 and the number of subjects achieving a total-mNAPSI 90 reported. The total-mNAPSI score can be assessed at any two timepoints from the timepoints disclosed herein. The total-mNAPSI score can similarly be assessed and tracked over time.

[0077] The term "mNAPSI 100," as used herein, refers to a 100% improvement in mNAPSI scores of a subject as compared at two time points. In some embodiments of the methods, compositions, and uses of the disclosure, the total-mNAPSI score at week 0 is compared to the same score at week 28 and the number of subjects achieving a total-mNAPSI 100 reported. The total-mNAPSI score can be assessed at any two timepoints from the timepoints disclosed herein. The total-NAPSI score can similarly be assessed and tracked over time.

[0078] The total-mNAPSI can also be used to assess nail psoriasis and the percentage of patients having a total-NPASI score of 0-100 compared. For instance, the nail psoriasis can be assigned a mNAPSI 0 to mNAPSI 100 score. However, the total mNAPSI scores most commonly assessed are mNAPSI 75, mNAPSI 90, and mNAPSI 100.

[0079] The term "moderate to severe nail psoriasis," as used herein, refers to an initial total- mNAPSI score of >20. An initial total mNAPSI score that is <20 can also indicate nail psoriasis but is considered a less severe psoriatic condition. Subjects having a total mNAPSI may still benefit from the methods disclosed herein and is not disqualified from receiving the humanized IL-23pl9 IgGl / K antibody.

[0080] The term "total fingernail mNAPSI," as used herein, refers to the total mNAPSI score as assessed only for the fingernails. This allows nail type comparisons. This allows for fingernail specific comparisons for improvements in nail psoriasis.

[0081] The term "total toenail mNAPSI," as used herein, refers to the total mNAPSI score as assessed only for the toenails. This allows for toenail specific comparisons for improvements in nail psoriasis. Thus, the total mNAPSI score can be fingernail or toenail specific. In some embodiments of the methods, compositions, and uses of the disclosure, the total mNAPSI 75, total mNAPSI 90, and total mNAPSI 100 can be nail specific. In alternate embodiments, the total mNAPSI 75, total mNAPSI 90, or total mNAPSI 100 scores for the toenails and fingernails can be grouped to assess global improvements in nail psoriasis.

[0082] The term "nails," as used herein, refers to toenails, fingernails, or both. As such nail psoriasis can be fingernail psoriasis, toenail psoriasis, or both. b. Visual Medical Scale to Evaluate Nail Psoriasis Severity (ViSENPsO)

[0083] The term "Visual Medical Scale to Evaluate Nail Psoriasis Severity" (ViSENPsO), as used herein, refers to a visual-based clinician-reported outcome (ClinRO) scale for assessing nail psoriasis severity. The ViSENPsO is a static scale developed by Sun Pharmaceuticals and used as an efficacy endpoint for promoting well-defined and reliable evaluations of nail psoriasis treatment outcomes in studies where a biological product is used.

[0084] In one embodiment, the disclosure provides a method of improving a ViSENPsO score in a subject with nail psoriasis, the method comprising administering an initial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4), and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0085] In another embodiment, the disclosure provides a method of improving a total- modified Nail Psoriasis Severity Index mNAPSI and / or ViSENPsO score, and / or total Nail Psoriasis Severity Index (NAPSI) in a subject with nail psoriasis, the method comprisingadministering an initial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0), administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4), and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0086] An initial ViSENPsO score of >3 is an indicator of moderate to severe nail psoriasis. A ViSENPsO score that is <3 can also indicate nail psoriasis but is considered a less severe psoriatic condition. Subjects having an initial ViSENPsO may still benefit from the methods, compositions, and uses disclosed herein and is not disqualified from receiving the humanized IL-23pl9 IgGl / K antibody.

[0087] The mNAPSI and / or ViSENPsO score can be used as an index of fingernail, toenail severity, or both. Comparisons are made between the same type of nails, and as such toenail mNAPSI and / or ViSENPsO scores are not compared between toenails and fingernails. However, toenail and fingernail mNAPSI and / or ViSENPsO scores can be combined to assess total nail psoriasis improvements.

[0088] The term "improvements in nail psoriasis" or "improved nail psoriasis," as used herein, refers to ViSENPsO score that decreases by a minimum of 2 points when compared at two timepoints. In some embodiments of the methods, compositions, and uses of the disclosure, the ViSENPsO score at weeks 0 and week 28 are compared to determine if a subject demonstrates improvements in nail psoriasis after receiving the humanized IL-23pl9 IgGl / K antibody. c. Nail Pain Numeric Rating Scale (NRS)

[0089] The term "nail pain numeric rating scale" (NRS), as used herein, refers to an assessment tool that subjects use to report the intensity of nail pain. An improvement of 30% in Nail Pain NRS score from Baseline at Week 28 is considered an efficacious outcome. Pain measurement uses a 30% threshold using the "worst pain" item. Efficacy is assessed using a decrease in absolute nail pain NRS score of at least 3 points on a scale of 0 to 10, with 0 being "no nail pain" and 10 being the "worst nail pain imaginable". NRS is subjectively assessed at each visit as the worst pain experienced during the previous 24 hours, on each of the seven consecutive days leading up to the assessment and the average calculated. A complete score at a given timepoint is based on an average of no less than four of the seven daily recall observations.

[0090] In one embodiment, the disclosure provides a method of improving a nail pain numeric rating scale (NRS) score in a subject with nail psoriasis, the method comprising administering an initial dose of a humanized IL-23pl9 IgGl / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4); and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0091] In some embodiments of the methods, compositions, and uses of the disclosure, the NRS score can be used as an index of fingernail, toenail severity, or both. Comparisons are made between the same type of nails, and as such NRS scores are not compared between toenails and fingernails. However, toenail and fingernail NRS scores can be combined to assess total nail psoriasis improvements. In some embodiments, improvements in nail psoriasis are achieved when the NRS score decreases by >30% between two timepoints. In one embodiment, improvements in nail psoriasis are achieved when the week 28 NRS is decreased by >30% when compared to the week 0 NRS.

[0092] The term "improvements in nail psoriasis" or "improved nail psoriasis," as used herein, refers to ViSENPsO score that decreases by a minimum of 2 points when compared at two timepoints. In one embodiment the ViSENPsO score at weeks 0 and week 28 are compared to determine if a subject demonstrates improvements in nail psoriasis after receiving the humanized IL-23pl9 IgGl / K antibody.

[0093] Any number of the nail psoriasis indices disclosed herein can be determined in a subject. In one embodiment of the current disclosure is a method for improving a total- modified Nail Psoriasis Severity Index (mNAPSI) and / or a Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score, and / or total Nail Psoriasis Severity Index (NAPSI) in a subject with nail psoriasis, the method comprising administering an initial dose of a humanized IL- 23pl9 IgGl / K antibody to the subject at baseline (week 0); administering a second dose of the humanized IL-23pl9 IgGl / K antibody to the subject at about four weeks after the initial dose (week 4), and administering additional doses of the humanized IL-23pl9 IgGl / K antibody to the subject at about sixteen weeks after administration of the initial dose (week 16) and about every twelve weeks thereafter; wherein the last dose is administered to the subject at about 52 weeks after the initial dose.

[0094] The humanized IL-23pl9 IgGl / K antibody can be administered at multiple time points. In one aspect, the humanized IL-23pl9 IgGl / K antibody is administered at multiple time points after an initial (z.e., week 0) administration.

[0095] The term "baseline" or "week 0," as used herein, refers to the initial administration of the humanized IL-23pl9 IgGl / K antibody. In certain embodiments, the term "baseline," as used herein, can refer to the last observed value of the parameter of interest prior to the first intake of study treatment (this includes unscheduled visits). Thereafter, the humanized IL- 23pl9 IgGl / K antibody can be administered at about every 4 weeks to about every 15 weeks. The antibody can be administered at about week 4, about week 8, about week 12, about week 16, about week 20, about week 24, about week 28, about week 32, about week 36, about week 40, about week 44, about week 48, or at about week 52 after the baseline administration. The administrations can be evenly spaced (e.g., every four weeks) or staggered at non-equal intervals. In one embodiment, the humanized IL-23pl9 IgGl / K antibody is administered at about week 0, at about week 4, at about week 16, at about week 28, at about week 40, and at about week 52. Consistent with this, mNAPSI, NAPSI, ViSENPsO, and / or nail pain NRS is determined at the time of administration of the humanized IL-23pl9 IgGl / K antibody. d. Total Body Surface Area (BSA)

[0096] The term "total body surface area," as used herein, refers to a measure of overall plaque psoriasis severity. It is defined as the percentage of the total BSA affected by psoriasis. The overall BSA affected by psoriasis is measured at time points specified and measured using the palm method where the palm of the subject's hand (including the palmar aspects of the fingers) represents 1% of the BSA. The affected areas are then calculated by their size compared to the subject's palm. e. Static Physician 's Global Assessment (s-PGA)

[0097] The term "Physician's Global Assessment" (s-PGA), as used herein, refers to a 5, 6, or 7-point scoring ranging from 'clear' to 'severe' used to assess disease severity. In one embodiment of the disclosure, a 6-point scale is utilized to assess disease severity at a given timepoint. The s-PGA is used to determine if there is worsening of disease that warrants the discontinuation of the subject from the study. f. Clinician Global Impression of Change (CGIC)

[0098] The term "Clinician Global Impression of Change," as used herein, refers to a questionnaire that reflects a clinician's belief about the efficacy of treatment. g. Clinician Global Impression of Severity (CGIS)

[0099] The term "Clinician Global Impression of Severity," as used herein, refers to a global index used by clinicians to rate the severity of a specific condition in patients. The scale is a single-state scale. h. Dermatology Life Quality Index (DLQI)

[0100] The term "Dermatology Life Quality Index," as used herein, refers to an index used to assess treatment response on the subject's quality of life. The aim of this questionnaire is to measure how much the nail psoriasis has affected the subject's life during the previous week (see Figure 4).

[0101] The self-recall asks subjects to recall their experiences during the previous week by responding to 10 questions. The DLQI is completed by the subject in the prior to any safety or efficacy evaluations. The questionnaire is self-explanatory and handed to the subject, who is asked to fill it in without the need for a detailed explanation. i. Nail Assessment in Psoriasis and Psoriatic Arthritis QoL (NAPPA-QoL)

[0102] The term "Nail Assessment in Psoriasis and Psoriatic Arthritis QoL" (NAPPA- QoL), as used herein, refers to a questionnaire that describes the QoL with nail psoriasis on the hands and / or feet over the past week (Figure 5).J. Patient Global Impression of Change (PGIC)

[0103] The term "Patient Global Impression of Change (PGIC)," as used herein, refers to a questionnaire that reflects a patient's belief about the efficacy of treatment. k. Patient Global Impression of Change for pain (PGIC-P)

[0104] The term "Patient Global Impression of Change" (PGIC-P), as used herein, is a global index used to rate the change of any clinical condition and will be used herein to evaluate change of nail pain (i.e., PGIC-P). l. Patient Global Impression of Severity (PGIS)

[0105] The term "Patient Global Impression of Severity" (PGIS), as used herein, is a global index that may be used to rate the severity of a specific condition (a single-state scale). m. Patient Global Impression of Severity for pain (PGIS-P)

[0106] The term "Patient Global Impression of Severity for pain" (PGIS-P), as used herein, is a global index that may be used to rate the severity of any clinical condition. The PGIS-P is used herein to evaluate the intensity of nail pain with the responses being recorded at the post-baseline visits wherein PGIS will also be recorded.

[0107] All measures psoriasis severity, pain, treatment efficacy, and quality of life are administered at one or more timepoints disclosed herein. In one embodiment, the measures are assessed at week 0, week 4, week 16, week 28, week 40, and week 52.

[0108] The efficacy assessments ViSENPsO, NAPSI, and mNAPSI, PGA-S, BSA, PASI, and nail pain NRS score are assessed at each visit during the study. The subject selfcompleted assessment of efficacy including the Patient Reported Outcomes (PROs) and in particular the Dermatology Life Quality Index [DLQI], Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life [NAPPA-QoL], the nail pain NRS, Patient Global Impression of Change [PGIC], Patient Global Impression of Change for pain [PGIC-P], Patient Global Impression of Severity [PGIS], Patient Global Impression of Severity for pain [PGIS-P], and Columbia Suicidal Severity Rating Scale [C-SSRS]).Embodiments

[0109] Embodiment 1 : A method of treating nail psoriasis in a subject in need thereof, the method comprising administering a therapeutically effective amount of an anti- IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0110] Embodiment 2: The method of embodiment 1, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0111] Embodiment 3: The method of embodiment 1, wherein the subject has plaque psoriasis.

[0112] Embodiment 4: The method of embodiment 1, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0113] Embodiment 5: The method of embodiment 2, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg.

[0114] Embodiment 6: The method of embodiment 1, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg.

[0115] Embodiment 7: The method of embodiment 1, wherein the first dose, second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.

[0116] Embodiment 8: The method of embodiment 1, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject subcutaneously.

[0117] Embodiment 9: The method of embodiment 8, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject by subcutaneous injection.

[0118] Embodiment 10: The method of embodiment 8, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the abdominal area of the subject.

[0119] Embodiment 11: The method of embodiment 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in one or more of:(a) an improved total-modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score in the subject; and / or(c) an improved total Nail Psoriasis Severity Index (NAPSI) in the subject.

[0120] Embodiment 12: The method of embodiment 11, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0121] Embodiment 13: The method of embodiment 11, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0122] Embodiment 14: The method of embodiment 11, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0123] Embodiment 15: The method of embodiment 11, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0124] Embodiment 16: The method of embodiment 11, wherein the total -mNAPSI is total-fingernail mNAPSI.

[0125] Embodiment 17: The method of embodiment 16, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.

[0126] Embodiment 18: The method of embodiment 16, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.

[0127] Embodiment 19: The method of embodiment 18, wherein the NAPSI is totalfingernail NAPSI.

[0128] Embodiment 20: The method of embodiment 19, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.

[0129] Embodiment 21 : The method of embodiment 19, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingemail NAPSI.

[0130] Embodiment 22: The method of embodiment 19, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0131] Embodiment 23: The method of embodiment 11, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0132] Embodiment 24: The method of embodiment 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in an improved nail pain numeric rating scale (NRS) score in the subject.

[0133] Embodiment 25: The method of embodiment 24, wherein the subject has a week 0 NRS score of >3.

[0134] Embodiment 26: The method of embodiment 24, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0135] Embodiment 27: The method of embodiment 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in one or more of:(a) an improved Modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Nail Psoriasis Severity Index (NAPSI) in the subject;(c) an improved Visual medical scale to evaluate nail psoriasis severity (ViSENPsO) in the subject; and / or(d) an improved nail pain numeric rating scale (NRS) score in the subject.

[0136] Embodiment 28: The method of embodiment 27, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0137] Embodiment 29: The method of embodiment 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in an increased Quality of Life (QoL) in the subject.

[0138] Embodiment 30: The method of any of the preceding embodiments, wherein one or more doses of the anti-IL-23pl9 antibody huml3B8-b are administered to the subject using a ready-to-use, prefdled syringe.

[0139] Embodiment 31: The method of embodiment 30, wherein the prefdled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.

[0140] Embodiment 32: The method of embodiment 31, wherein the prefdled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0141] Embodiment 33: A method of improving one or more of:(a) total-modified Nail Psoriasis Severity Index (mNAPSI);(b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or(c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0142] Embodiment 34: The method of embodiment 33, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0143] Embodiment 35: The method of embodiment 33, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0144] Embodiment 36: The method of embodiment 33, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0145] Embodiment 37: The method of embodiment 33, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0146] Embodiment 38: The method of embodiment 33, wherein the total -mNAPSI is total-fingernail mNAPSI.

[0147] Embodiment 39: The method of embodiment 38, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.

[0148] Embodiment 40: The method of embodiment 38, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.

[0149] Embodiment 41 : The method of embodiment 33, wherein the NAPSI is total- fingemail NAPSI.

[0150] Embodiment 42: The method of embodiment 41, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.

[0151] Embodiment 43: The method of embodiment 41, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingemail NAPSI.

[0152] Embodiment 44: The method of embodiment 41, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0153] Embodiment 45: The method of embodiment 33, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0154] Embodiment 46: A method of improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subjectabout 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0155] Embodiment 47: The method of embodiment 46, wherein the subject has a week 0 NRS score of >3.

[0156] Embodiment 48: The method of embodiment 46, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0157] Embodiment 49: A method of improving one or more of:(a) Modified Nail Psoriasis Severity Index (mNAPSI);(b) Nail Psoriasis Severity Index (NAPSI);(c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or(d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0158] Embodiment 50: The method of embodiment 49, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0159] Embodiment 51: A method of increasing Quality of Life (QoL) in a subject with nail psoriasis, the method comprising a therapeutically effective amount of an anti-IL- 23pl9 antibody huml3B8-b to the subject;wherein a first dose of a huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0160] Embodiment 52: The method of any one of embodiments 33 to 51, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0161] Embodiment 53: The method of any one of embodiments 33 to 51, wherein the subject has plaque psoriasis.

[0162] Embodiment 54: The method of any one of embodiments 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0163] Embodiment 55: The method of embodiment 54, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg.

[0164] Embodiment 56: The method of any one of embodiments 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg.

[0165] Embodiment 57: The method of any one of embodiments 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.

[0166] Embodiment 58: The method of any of embodiments 33 to 57, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject subcutaneously.

[0167] Embodiment 59: The method of embodiment 58, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject by subcutaneous injection.

[0168] Embodiment 60: The method of embodiment 58, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the abdominal area of the subject.

[0169] Embodiment 61: The method of any of embodiments 33 to 60, wherein one or more doses of the anti-IL-23pl9 antibody huml3B8-b are administered to the subject using a ready -to-use, prefilled syringe.

[0170] Embodiment 62: The method of embodiment 61, wherein the prefilled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.

[0171] Embodiment 63: The method of embodiment 62, wherein the prefdled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0172] Embodiment 64: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in a subject; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0173] Embodiment 65 : The pharmaceutical composition of embodiment 64, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0174] Embodiment 66: The pharmaceutical composition of embodiment 64, wherein the subject has plaque psoriasis.

[0175] Embodiment 67 : The pharmaceutical composition of embodiment 64, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0176] Embodiment 68: The pharmaceutical composition of embodiment 65, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8- b.

[0177] Embodiment 69: The pharmaceutical composition of embodiment 64, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.

[0178] Embodiment 70: The pharmaceutical composition of embodiment 64, wherein the first dose, second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.

[0179] Embodiment 71 : The pharmaceutical composition of embodiment 64, wherein the pharmaceutical composition is administered to the subject subcutaneously.

[0180] Embodiment 72: The pharmaceutical composition of embodiment 71, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.

[0181] Embodiment 73: The pharmaceutical composition of embodiment 71, wherein the pharmaceutical composition is administered to the abdominal area of the subject.

[0182] Embodiment 74: The pharmaceutical composition of embodiment 64, wherein administration of the pharmaceutical composition results in one or more of:(a) an improved total-modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score in the subject; and / or(c) an improved total Nail Psoriasis Severity Index (NAPSI) in the subject.

[0183] Embodiment 75: The pharmaceutical composition of embodiment 74, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0184] Embodiment 76: The pharmaceutical composition of embodiment 74, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0185] Embodiment 77: The pharmaceutical composition of embodiment 74, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0186] Embodiment 78: The pharmaceutical composition of embodiment 74, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0187] Embodiment 79: The pharmaceutical composition of embodiment 74, wherein the total-mNAPSI is total-fingernail mNAPSI.

[0188] Embodiment 80: The pharmaceutical composition of embodiment 79, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.

[0189] Embodiment 81: The pharmaceutical composition of embodiment 79, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.

[0190] Embodiment 82: The pharmaceutical composition of embodiment 81, wherein the NAPSI is total-fingemail NAPSI.

[0191] Embodiment 83: The pharmaceutical composition of embodiment 82, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.

[0192] Embodiment 84: The pharmaceutical composition of embodiment 82, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingernail NAPSI.

[0193] Embodiment 85: The pharmaceutical composition of embodiment 82, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0194] Embodiment 86: The pharmaceutical composition of embodiment 74, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0195] Embodiment 87: The pharmaceutical composition of embodiment 64, wherein administration of the pharmaceutical composition in an improved nail pain numeric rating scale (NRS) score in the subject.

[0196] Embodiment 88: The pharmaceutical composition of embodiment 87, wherein the subject has a week 0 NRS score of >3.

[0197] Embodiment 89: The pharmaceutical composition of embodiment 87, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0198] Embodiment 90: The pharmaceutical composition of embodiment 64, wherein administration of the pharmaceutical composition results in one or more of:(a) an improved Modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Nail Psoriasis Severity Index (NAPSI) in the subject;(c) an improved Visual medical scale to evaluate nail psoriasis severity (ViSENPsO) in the subject; and / or(d) an improved nail pain numeric rating scale (NRS) score in the subject.

[0199] Embodiment 91 : The pharmaceutical composition of embodiment 90, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0200] Embodiment 92: The pharmaceutical composition of embodiment 64, wherein administration of the pharmaceutical composition results in an increased Quality of Life (QoL) in the subject.

[0201] Embodiment 93: The pharmaceutical composition of any of the preceding embodiments, wherein one or more doses of the pharmaceutical composition are administered to the subject using a ready-to-use, prefilled syringe.

[0202] Embodiment 94: The pharmaceutical composition of embodiment 93, wherein the prefilled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.

[0203] Embodiment 95 : The pharmaceutical composition of embodiment 94, wherein the prefilled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0204] Embodiment 96: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of:(a) total-modified Nail Psoriasis Severity Index (mNAPSI);(b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or(c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0205] Embodiment 97 : The pharmaceutical composition of embodiment 96, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0206] Embodiment 98: The pharmaceutical composition of embodiment 96, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0207] Embodiment 99: The pharmaceutical composition of embodiment 96, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0208] Embodiment 100: The pharmaceutical composition of embodiment 96, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0209] Embodiment 101: The pharmaceutical composition of embodiment 96, wherein the total-mNAPSI is total-fingernail mNAPSI.

[0210] Embodiment 102: The pharmaceutical composition of embodiment 101, wherein the subject has a week 28 total-fingernail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingernail mNAPSI.

[0211] Embodiment 103: The pharmaceutical composition of embodiment 101, wherein the subject has a week 28 total-fingernail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingernail mNAPSI.

[0212] Embodiment 104: The pharmaceutical composition of embodiment 96, wherein the NAPSI is total-fingernail NAPSI.

[0213] Embodiment 105: The pharmaceutical composition of embodiment 104, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingernail NAPSI.

[0214] Embodiment 106: The pharmaceutical composition of embodiment 104, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingernail NAPSI.

[0215] Embodiment 107: The pharmaceutical composition of embodiment 104, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0216] Embodiment 108: The pharmaceutical composition of embodiment 96, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0217] Embodiment 109: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; andwherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0218] Embodiment 110: The pharmaceutical composition of embodiment 109, wherein the subject has a week 0 NRS score of >3.

[0219] Embodiment 111: The pharmaceutical composition of embodiment 109, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0220] Embodiment 112: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of:(a) Modified Nail Psoriasis Severity Index (mNAPSI);(b) Nail Psoriasis Severity Index (NAPSI);(c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or(d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0221] Embodiment 113: The pharmaceutical composition of embodiment 112, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0222] Embodiment 114: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for increasing Quality of Life (QoL) in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the firstdose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0223] Embodiment 115: The pharmaceutical composition of any one of embodiments 96 to 114, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0224] Embodiment 116: The pharmaceutical composition of any one of embodiments 96 to 114, wherein the subject has plaque psoriasis.

[0225] Embodiment 117: The pharmaceutical composition of any one of embodiments 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0226] Embodiment 118: The pharmaceutical composition of embodiment 117, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8-b.

[0227] Embodiment 119: The pharmaceutical composition of any one of embodiments 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.

[0228] Embodiment 120: The pharmaceutical composition of any one of embodiments 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.

[0229] Embodiment 121: The pharmaceutical composition of any of embodiments 96 to 120, wherein the pharmaceutical composition is administered to the subject subcutaneously.

[0230] Embodiment 122: The pharmaceutical composition of embodiment 121, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.

[0231] Embodiment 123: The pharmaceutical composition of embodiment 121, wherein the pharmaceutical composition is administered to the abdominal area of the subject.

[0232] Embodiment 124: The pharmaceutical composition of any of embodiments 96 to 123, wherein one or more doses of the pharmaceutical composition are administered to the subject using a ready-to-use, prefilled syringe.

[0233] Embodiment 125: The pharmaceutical composition of embodiment 124, wherein the prefdled syringe contains about 100 mg of huml3B8-b, an excipient, and a buffer.

[0234] Embodiment 126: The pharmaceutical composition of embodiment 125, wherein the prefdled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0235] Embodiment 127: Use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for treating nail psoriasis in a subject; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0236] Embodiment 128: The use of embodiment 127, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0237] Embodiment 129: The use of embodiment 127, wherein the subject has plaque psoriasis.

[0238] Embodiment 130: The use of embodiment 127, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0239] Embodiment 131: The use of embodiment 128, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8-b.

[0240] Embodiment 132: The use of embodiment 127, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.

[0241] Embodiment 133: The use of embodiment 127, wherein the first dose, second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.

[0242] Embodiment 134: The use of embodiment 127, wherein the medicament is administered to the subject subcutaneously.

[0243] Embodiment 135: The use of embodiment 134, wherein the medicament is administered to the subject by subcutaneous injection.

[0244] Embodiment 136: The use of embodiment 134, wherein the medicament is administered to the abdominal area of the subject.

[0245] Embodiment 137: The use of embodiment 127, wherein administration of the medicament results in one or more of:(a) an improved total-modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score in the subject; and / or(c) an improved total Nail Psoriasis Severity Index (NAPSI) in the subject.

[0246] Embodiment 138: The use of embodiment 137, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0247] Embodiment 139: The use of embodiment 137, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0248] Embodiment 140: The use of embodiment 137, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0249] Embodiment 141: The use of embodiment 137, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0250] Embodiment 142: The use of embodiment 137, wherein the total -mNAPSI is total-fingernail mNAPSI.

[0251] Embodiment 143: The use of embodiment 142, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.

[0252] Embodiment 144: The use of embodiment 142, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.

[0253] Embodiment 145: The use of embodiment 144, wherein the NAPSI is total- fingemail NAPSI.

[0254] Embodiment 146: The use of embodiment 145, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.

[0255] Embodiment 147: The use of embodiment 145, wherein the subject has a week 28 total-fingernail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingernail NAPSI.

[0256] Embodiment 148: The use of embodiment 145, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0257] Embodiment 149: The use of embodiment 137, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0258] Embodiment 150: The use of embodiment 127, wherein administration of the medicament in an improved nail pain numeric rating scale (NRS) score in the subject.

[0259] Embodiment 151: The use of embodiment 150, wherein the subject has a week 0 NRS score of >3.

[0260] Embodiment 152: The use of embodiment 150, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0261] Embodiment 153: The use of embodiment 127, wherein administration of the medicament results in one or more of:(a) an improved Modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Nail Psoriasis Severity Index (NAPSI) in the subject;(c) an improved Visual medical scale to evaluate nail psoriasis severity (ViSENPsO) in the subject; and / or(d) an improved nail pain numeric rating scale (NRS) score in the subject.

[0262] Embodiment 154: The use of embodiment 153, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0263] Embodiment 155: The use of embodiment 127, wherein administration of the medicament results in an increased Quality of Life (QoL) in the subject.

[0264] Embodiment 156: The use of any of the preceding embodiments, wherein one or more doses of the medicament are administered to the subject using a ready-to-use, prefilled syringe.

[0265] Embodiment 157: The use of embodiment 156, wherein the prefilled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.

[0266] Embodiment 158: The use of embodiment 157, wherein the prefilled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0267] Embodiment 159: Use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving one or more of:(a) total-modified Nail Psoriasis Severity Index (mNAPSI);(b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or(c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0268] Embodiment 160: The use of embodiment 159, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.

[0269] Embodiment 161: The use of embodiment 159, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.

[0270] Embodiment 162: The use of embodiment 159, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.

[0271] Embodiment 163: The use of embodiment 159, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.

[0272] Embodiment 164: The use of embodiment 159, wherein the total -mNAPSI is total-fingemail mNAPSI.

[0273] Embodiment 165: The use of embodiment 164, wherein the subject has a week 28 total-fingernail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingernail mNAPSI.

[0274] Embodiment 166: The use of embodiment 164, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.

[0275] Embodiment 167: The use of embodiment 159, wherein the NAPSI is total- fingemail NAPSI.

[0276] Embodiment 168: The use of embodiment 167, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.

[0277] Embodiment 169: The use of embodiment 167, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingemail NAPSI.

[0278] Embodiment 170: The use of embodiment 167, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.

[0279] Embodiment 171: The use of embodiment 159, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.

[0280] Embodiment 172: Use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0281] Embodiment 173: The use of embodiment 172, wherein the subject has a week 0 NRS score of >3.

[0282] Embodiment 174: The use of embodiment 172, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.

[0283] Embodiment 175: Use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for improving one or more of:(a) Modified Nail Psoriasis Severity Index (mNAPSI);(b) Nail Psoriasis Severity Index (NAPSI);(c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or(d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0284] Embodiment 176: The use of embodiment 175, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.

[0285] Embodiment 177: Use of an anti-IL-23pl9 antibody huml3B8-b for the manufacture of a medicament for increasing Quality of Life (QoL) in a subject with nail psoriasis; wherein a first dose of the medicament is administered to the subject on week 0, a second dose of the medicament is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the medicament are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the medicament is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0286] Embodiment 178: The use of any one of embodiments 159 to 177, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.

[0287] Embodiment 179: The use of any one of embodiments 159 to 177, wherein the subject has plaque psoriasis.

[0288] Embodiment 180: The use of any one of embodiments 159 to 177, wherein the first dose, second dose, subsequent doses, and final dose are the same.

[0289] Embodiment 181: The use of embodiment 180, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8-b.

[0290] Embodiment 182: The use of any one of embodiments 159 to 177, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.

[0291] Embodiment 183: The use of any one of embodiments 159 to 177, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.

[0292] Embodiment 184: The use of any of embodiments 159 to 183, wherein the medicament is administered to the subject subcutaneously.

[0293] Embodiment 185 : The use of embodiment 184, wherein the medicament is administered to the subject by subcutaneous injection.

[0294] Embodiment 186: The use of embodiment 184, wherein the medicament is administered to the abdominal area of the subject.

[0295] Embodiment 187: The use of any of embodiments 159 to 186, wherein one or more doses of the medicament are administered to the subject using a ready-to-use, prefilled syringe.

[0296] Embodiment 188: The use of embodiment 187, wherein the prefilled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.

[0297] Embodiment 189: The use of embodiment 188, wherein the prefilled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.

[0298] Embodiment 190: A method of treating nail psoriasis in a subject in need thereof, the method comprising administering a therapeutically effective amount of an antibody comprising a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.EXAMPLES

[0299] The claimed invention is further demonstrated by the following Examples, which should not be construed as limiting. Those of skill in the art will recognize that the claimed invention may be practiced with variations of the disclosed materials, formulations, and methods, and such variations are within the scope of the claimed invention.Example 1: Anti-IL23pl9 Antibody Treatment of Nail PsoriasisSubjects

[0300] Eligible patients with moderate to severe plaque psoriasis and concomitant moderate to severe nail psoriasis were randomized in a 1 : 1 ratio into one of the treatment groups as shown in Table 3.Table 3. Treatment Groups00301] A multicenter, randomized, double-blind, placebo-controlled study was performed to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the nails. Treatments were administered to subjects in Arm A and Arm B,as provided in Table 4. The study duration per subject was approximately 18 to 19 months, including a treatment duration of 52 weeks, with a total study duration of approximately 3 years.Table 4. Treatment ScheduleInclusion and Exclusion Criteria

[0302] Patients were eligible to participate in the study if they satisfied all the inclusion qualifiers in Table 5, and patients were automatically excluded if any of the criteria applied in Table 6. Indicators of a fungal nail infection (Table 7) are important to observe since it can confound the efficacy of the treatment. Thus, individuals with positive indicators of fungal infection were dismissed from the study. Finally, certain classes of drugs needed to stop being used before randomization for the study occurred (Table 8), and some pharmaceuticals are outright disqualifying for their use (Table 9).Table 5. Inclusion CriteriaTable 6. Exclusion Criteriaingredients of the Tildrakizumab or placebo formulations.Table 7. Definition and Diagnosis of Fungal Nail Infection

[0303] Use of any of the medications within the indicated washout period prior to baseline randomization excluded the patient from the study.Table 8. Excluded Medications Prior to Randomization

[0304] The concomitant use of an excluded medication / therapy during study treatment was not in compliance with the study protocol and needed to be recorded in the eCRF.Table 9. Excluded Medications and TherapiesObjectives and Endpoints

[0305] Table 10 outlines the objectives of the clinical trial and efficacy endpoints.Table 10. Objectives and Endpoints of the Clinical TrialExample 2: Efficacy Assessments

[0306] Efficacy assessments were measured as detailed above and presented in Table 10. The Nail Psoriasis Severity Index (NPSI) is utilized by first dividing the nail with an imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant.

[0307] In each quadrant of the nail, nail matrix psoriasis is evaluated by presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1 quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail.

[0308] Nail bed psoriasis is evaluated by the presence of any of the nail bed features including onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschromia). Nail bed psoriasis is scored as: 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants, 3 for 3 quadrants, and 4 for 4 quadrants.

[0309] Each nail receives a matrix score and a nail bed score, the total of which is the score for that nail (0-8). Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all fingernails is 0-80.Modified Nail Psoriasis Severity Index (mNAPSI)

[0310] The mNAPSI is an assessment of nail abnormality for each of a subject's nails and measured as detailed above and presented in Table 1. Pitting, onycholysis and oil-drop dyschromia, and crumbling of each fingernail are graded on a scale from zero to 3. Leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula are graded as either present or absent for each fingernail (see Table 1).Physician 's Global Assessment of Skin- Whole Body (PGA-S)

[0311] A systematic review was conducted to evaluate the degree of correlation between the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). The assessment scores were recorded and compared the percent of patients achieving both a 75% reduction in PASI score (PASI 75) and PGA of 0 or 1 (clear or almost clear) at 8 to 16 weeks, 17 to 24 weeks, and greater than 24 weeks of treatment with the investigational drug.

[0312] The two assessment tools correlate very tightly except at the lower bounds of therapeutic efficacy. The r(2) values for the correlation between PASI 75 and a score of clear or almost clear on the PGA were 0.9157 at 8 to 16 weeks and 0.892 at 17 to 24 weeks.Because the two assessment tools are substantially redundant either alone is a sufficient tool for assessing psoriasis severity in patients with moderate to severe disease.

[0313] Plaque psoriasis was assessed using a 6-point Physician's Global Assessment of Skin scale to determine the overall severity of a subject's psoriasis lesions at a given time point (Table 11).

[0314] The PGA-S was used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions were graded for thickness, erythema, and scaling based on the scales in Table 11 (below). The sum of the 3 scales was divided by 3 to obtain the final PGA score.Table 11. Physician's Global Assessment of Skin-Whole Body (PGA-S) Scoring System0 = Cleared, except for residual discoloration1 = Minimal - majority of lesions have individual scores for Thickness (T) + Erythema (E) + Scaling (S) / 3 that averages 1.2 = Mild - majority of lesions have individual scores for T + E + S / 3 that averages 2.3 = Moderate - majority of lesions have individual scores for T + E + S / 3 that averages 3.4 = Marked - majority of lesions have individual scores for T + E + S / 3 that averages 4.5 = Severe - majority of lesions have individual scores for T + E + S / 3 that averages 5.Psoriasis Area and Severity Index (PASI)

[0315] Psoriasis Area and Severity Index was used to determine the treatment response (PASI 75, PASI 90, and PASI 100) in subjects with nail psoriasis. The PASI includes scores on erythema, thickness, scaling, and percentage of BSA affected (Table 12).

[0316] The PASI consists of two major steps: (1) Calculating the BSA covered with lesions and (2) Assessing severity of lesions, including assessing the erythema (redness), induration (thickness), and scaling of the lesion.

[0317] All calculations are combined into a single PASI score in the range of 0 (no psoriasis on the body) and up to 72 (the most severe case of psoriasis).Table 12. Psoriasis Area and Severity Index (PASI)

[0318] The efficacy of the anti-IL23pl9 antibody is assessed via primary and secondary endpoints, as presented in Table 13.Table 13. Efficacy AnalysesStudy DesignPART 1: Double-blind Placebo-controlled (Day 1 to Week 28)

[0319] After a Screening Period of up to 28 days and on Day 1, all eligible subjects were randomized 1: 1 to receive either tildrakizumab 100 mg or placebo administered by SC injection on Week 0 (Day 1), Week 4, and Week 16. Subjects received the first dose of study treatment within 24 hours of randomization. The treatment period for the double -blind, placebo-controlled part of the study was 28 weeks.

[0320] Early Escape: At Week 16, subjects who experience significant worsening of plaque psoriasis (defined as an increase in s-PGA by at least 2 from the baseline measurement) were eligible for an early escape. Subjects selected for early escape had study medication discontinued but completed the End of Treatment visit assessment, followed by the observational safety follow-up period. Subjects entering early escape were replaced so as to meet the planned evaluable sample size goal for the primary endpoint analysis.

[0321] An optional interim analysis was performed that could include an unblinded sample size re-estimation (SSRE). The sample size of the study could be increased as a result of this SSRE. In the event of an increase in sample size, the total sample size of the study will not exceed a total of approximately 282 randomized subjects.PART 2: Double-blind Active Treatment Extension (Week 28 to Week 52)

[0322] At Week 28, subjects initially randomized to placebo will be switched over to receive tildrakizumab 100 mg at Weeks 28, 32, and 44. Subjects initially randomized to tildrakizumab 100 mg continued to receive tildrakizumab at Weeks 28, 40, and 52. In order to maintain the blind, subjects in both treatment arms received matching placebo injections at specified time points.

[0323] Subjects that experienced significant worsening of plaque psoriasis at Week 28 (defined as an increase in s-PGA by, at least 2 from the baseline measurement) werediscontinued from treatment. Subjects who do not fulfill this criterion at Week 28 continued to receive tildrakizumab in Part 2, as described above.PART 3: Observational Safety Follow-up (Week 52 to Week 72)

[0324] After Week 52 (or early termination of study treatment prior to Week 52), the study treatment was stopped and all subjects, including those who terminated early from Part 1 and, 2 entered a 20-week Observational Safety Follow-up period to monitor safety and tolerability for 20 weeks following the last dose of study treatment. During the follow-up period, subjects continued on study-approved concomitant medications only, and were placed on appropriate therapies for safety concerns or significant worsening of psoriasis. The subjects did not receive study treatment during the follow-up period.

[0325] The study may have a primary analysis, which is performed when the last subject has completed the Week 28 visit, and a final analysis performed when the last subject has completed the study.

[0326] Subjects who withdraw from the study will undergo the assessment that corresponds to the last assessment of the study part from which they are leaving. Subjects discontinued from study treatment at any time (apart from the withdrawal of informed consent) will complete the EoT (Week 52) assessment approximately 4 weeks after the last dose of study treatment and enter the 20-week observational safety follow-up. Subjects who withdraw from the study during Part 3 will undergo the Week 72 (End of Study [EoS]) assessments approximately 4 weeks after their last visit.Scientific Rationale for Study Design

[0327] This is a randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab administered by SC injection in subjects with moderate to severe nail psoriasis. In this study, tildrakizumab will be compared with a placebo.

[0328] The study was designed with 4 distinct phases (Screening, Double-blind Placebo-controlled period, Double-blind active treatment period, and an Observational safety follow-up period).

[0329] This enables scientific evaluation of efficacy at Week 28. The 52-week treatment duration is expected to provide adequate time to assess the safety and efficacy of tildrakizumab in subjects with nail psoriasis.Discontinuation of Study Treatment

[0330] Subjects could voluntarily discontinue study treatment for any reason at any time and enter the 20-week wash-out period or completely withdraw from the study.Subjects who entered the wash-out period underwent the Week 52 (EoT) assessment at approximately 4 weeks after administration of the last dose of study treatment.

[0331] The study treatment was discontinued under the following circumstances listed in Table 14 below, and the further steps need to be discussed with the Medical Monitor.Subjects discontinued from the study were not able to be replaced. Further, subjects who withdrew from the study had to undergo the assessment that corresponds to the end assessment of the study part which they were leaving. Week 52 assessments (EoT) were conducted approximately 4 weeks after administration of the last dose of the study treatment. See the Schedule of activities for data to be collected at the time of treatment discontinuation and follow-up and for any further evaluations that need to be completed.Table 14. Disqualifying Events from Treatment Study_Temporary Discontinuation

[0332] Table 15 provides instances where temporary discontinuation from study treatment would occur.Table 15. Causes of Temporary Discontinuation_Subject Discontinuation or Withdrawal from Study

[0333] Subjects could voluntarily withdraw consent to participate in the study for any reason at any time.Statistical Considerations

[0334] The primary efficacy endpoint for this study was the proportion of subjects who achieve at least a 75% improvement from baseline in total-mNAPSI at Week 28. The key secondary efficacy endpoint was the proportion of subjects with a score of "0 - normal" or " 1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO. For each endpoint, the tildrakizumab 100 mg dose was compared with the placebo at Week 28.

[0335] The overall study Type 1 error was controlled for the primary and secondary efficacy endpoints using the step-down sequential procedure to control the overall type I error rate at 0.05 level. The hierarchical order of testing the endpoints followed the sequence provided below:1. The proportion of subjects who achieve at least a 75% improvement from baseline in total-mNAPSI at Week 28 (Primary endpoint).2. The proportion of subjects with a score of "0 - normal" or " 1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO. (Key secondary endpoint)3. Change in total-fingernail mNAPSI score from baseline at Week 28.4. Change in total-fingernail NAPSI score from baseline at Week 28.5. The proportion of subjects achieving total-fingernail NAPSI 75 at Week 28.6. The proportion of subjects achieving total-fingernail mNAPSI 90 at Week 28.7. The proportion of subjects achieving total-fingernail NAPSI 90 at Week 28.8. The proportion of subjects achieving total-fingernail mNAPSI 100 at Week 28.9. The proportion of subjects achieving total-fingernail NAPSI 100 at Week 28. Populations for Analyses

[0336] For purposes of analysis, the analysis sets in Table 16 are defined.Table 16. Analysis SetsStatistical Analyses

[0337] The term "Baseline," as used herein, refers to last observed value of the parameter of interest prior to the first intake of study treatment (this includes unscheduled visits). For numerical variables, change from Baseline was calculated as the difference between the post-baseline value and the corresponding Baseline value.Example 3: Nail Psoriasis Phase 3b Study at 28 Weeks

[0338] An assessment of mNAPSI 75 response was conducted on a sample size of 96 patients (99 patients at final enrollment) at 28 weeks. The ViSENPsO response was also assessed at 28 weeks.

[0339] The demographics of the study population are outlined in Table 17.Table 17. Patient Demographics

[0340] Tildrakizumab 100 mg treatment among the ITT and NRI cohorts observed 25.5% of subjects achieved mNAPSI 75 response and 29.4% ViSENPsO response at 28 weeks (Table 18). Among the ITT and OC cohorts receiving Tildrakizumab 100 mg treatment, 30.2% of subjects achieved mNAPSI 75 (Table 19). Approximately 33.3% subjects of both the PPS / NRI and PPS / OC populations experienced mNAPSI 75 response (Table 20). Further, 60.6% subjects experienced a 30% decrease in nail pain, 58.7% of subjects achieved PASI 75, 33.3% of subjects achieved PASI 90 response, and 25.5% of subjects achieved a PASI 100 response (Table 20). Further, 51% of subjects experienced at least a 2-point reduction from baseline PGA score (Table 20). Competitor therapeutics such as Adalimumab, Guselkizumab, Risankizumab, and Brodalumab were also evaluated for overall efficacy among the treatment and placebo groups (Table 23). The Physician Global Assessment of Fingernails and the modified Nail Psoriasis Severity Index were used to evaluate efficacy 12, 16, 24, or 26 weeks (Table 23).

[0341] Tildrakizumab 100 mg demonstrated high tolerance with low drug related treatment-emergent adverse events (TEAEs) or serious TEAEs (Table 21). More specifically, infections and infestations and injection related reactions were experienced during treatment (Table 22).

[0342] Tildrakizumab 100 mg treatment for nail psoriasis had demonstrated efficacy and tolerance at 28 weeks, with no serious drug-related adverse events, discontinuation, or death at 28 weeks of treatment.Table 18. Efficacy Measured by Primary EndpointsTable 19. Supportive Analysis of Efficacy OutcomesTable 20. Efficacy Measured by Secondary EndpointsTable 21. Adverse Events (SAF)Table 22. Subjects with Drug-Related TEAEsTable 23. Response Rate of Competitor Molecules

Claims

WHAT IS CLAIMED IS:Claim 1: A method of treating nail psoriasis in a subject in need thereof, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 2: The method of claim 1, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.Claim 3: The method of claim 1, wherein the subject has plaque psoriasis.Claim 4: The method of claim 1, wherein the first dose, second dose, subsequent doses, and final dose are the same.Claim 5: The method of claim 2, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg.Claim 6: The method of claim 1, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg.Claim 7: The method of claim 1, wherein the first dose, second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.Claim 8: The method of claim 1, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject subcutaneously.Claim 9: The method of claim 8, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject by subcutaneous injection.Claim 10: The method of claim 8, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the abdominal area of the subject.Claim 11: The method of claim 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in one or more of:(a) an improved total-modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score in the subject; and / or(c) an improved total Nail Psoriasis Severity Index (NAPSI) in the subject.Claim 12: The method of claim 11, wherein the subject has a week 0 total-mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.Claim 13: The method of claim 11, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.Claim 14: The method of claim 11, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.Claim 15: The method of claim 11, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.Claim 16: The method of claim 11, wherein the total-mNAPSI is total -fingernail mNAPSI.Claim 17: The method of claim 16, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total- fingemail mNAPSI.Claim 18: The method of claim 16, wherein the subject has a week 28 total -fingernail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingernail mNAPSI.Claim 19: The method of claim 18, wherein the NAPSI is total-fingernail NAPSI.Claim 20: The method of claim 19, wherein the subject has a week 28 total-fingemailNAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total- fingemail NAPSI.Claim 21 : The method of claim 19, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total- fingemail NAPSI.Claim 22: The method of claim 19, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total- fingemail NAPSI.Claim 23: The method of claim 11, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.Claim 24: The method of claim 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in an improved nail pain numeric rating scale (NRS) score in the subject.Claim 25: The method of claim 24, wherein the subject has a week 0 NRS score of >3.Claim 26: The method of claim 24, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.Claim 27: The method of claim 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in one or more of:(a) an improved Modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Nail Psoriasis Severity Index (NAPSI) in the subject;(c) an improved Visual medical scale to evaluate nail psoriasis severity (ViSENPsO) in the subject; and / or(d) an improved nail pain numeric rating scale (NRS) score in the subject.Claim 28: The method of claim 27, wherein the subject has a week 28 mNAPSI, NAPSI,ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.Claim 29: The method of claim 1, wherein administration of the anti-IL-23pl9 antibody huml3B8-b results in an increased Quality of Life (QoL) in the subject.Claim 30: The method of any of the preceding claims, wherein one or more doses of the anti-IL-23pl9 antibody huml3B8-b are administered to the subject using a ready-to-use, prefdled syringe.Claim 31: The method of claim 30, wherein the prefdled syringe contains about 100 mg of huml3B8-b, an excipient, and a buffer.Claim 32: The method of claim 31, wherein the prefdled syringe further comprises L- Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.Claim 33: A method of improving one or more of:(a) total-modified Nail Psoriasis Severity Index (mNAPSI);(b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or(c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; andwherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 34: The method of claim 33, wherein the subject has a week 0 total-mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.Claim 35: The method of claim 33, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.Claim 36: The method of claim 33, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.Claim 37: The method of claim 33, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.Claim 38: The method of claim 33, wherein the total-mNAPSI is total-fingernail mNAPSI.Claim 39: The method of claim 38, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total- fingemail mNAPSI.Claim 40: The method of claim 38, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.Claim 41 : The method of claim 33, wherein the NAPSI is total-fingemail NAPSI.Claim 42: The method of claim 41, wherein the subject has a week 28 total-fingemailNAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total- fingemail NAPSI.Claim 43: The method of claim 41, wherein the subject has a week 28 total -fingernail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 totalfingernail NAPSI.Claim 44: The method of claim 41, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total- fingemail NAPSI.Claim 45: The method of claim 33, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.Claim 46: A method of improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 47: The method of claim 46, wherein the subject has a week 0 NRS score of >3.Claim 48: The method of claim 46, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.Claim 49: A method of improving one or more of:(a) Modified Nail Psoriasis Severity Index (mNAPSI);(b) Nail Psoriasis Severity Index (NAPSI);(c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or(d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis, the method comprising administering a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 50: The method of claim 49, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.Claim 51: A method of increasing Quality of Life (QoL) in a subject with nail psoriasis, the method comprising a therapeutically effective amount of an anti-IL-23pl9 antibody huml3B8-b to the subject; wherein a first dose of a huml3B8-b is administered to the subject on week 0, a second dose of huml3B8-b is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of huml3B8-b are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of huml3B8-b is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 52: The method of any one of claims 33 to 51, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.Claim 53: The method of any one of claims 33 to 51, wherein the subject has plaque psoriasis.Claim 54: The method of any one of claims 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are the same.Claim 55: The method of claim 54, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg.Claim 56: The method of any one of claims 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg.Claim 57: The method of any one of claims 33 to 51, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg.Claim 58: The method of any of claims 33 to 57, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject subcutaneously.Claim 59: The method of claim 58, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the subject by subcutaneous injection.Claim 60: The method of claim 58, wherein the anti-IL-23pl9 antibody huml3B8-b is administered to the abdominal area of the subject.Claim 61 : The method of any of claims 33 to 60, wherein one or more doses of the anti-IL-23pl9 antibody huml3B8-b are administered to the subject using a ready-to-use, prefilled syringe.Claim 62: The method of claim 61, wherein the prefilled syringe contains about 100 mg of huml3B8-b, an excipient, and a buffer.Claim 63 : The method of claim 62, wherein the prefilled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.Claim 64: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for the treatment of nail psoriasis in a subject; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 65: The pharmaceutical composition of claim 64, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.Claim 66: The pharmaceutical composition of claim 64, wherein the subject has plaque psoriasis.Claim 67: The pharmaceutical composition of claim 64, wherein the first dose, second dose, subsequent doses, and final dose are the same.Claim 68: The pharmaceutical composition of claim 65, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8-b.Claim 69: The pharmaceutical composition of claim 64, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.Claim 70: The pharmaceutical composition of claim 64, wherein the first dose, second dose, and subsequent doses are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.Claim 71 : The pharmaceutical composition of claim 64, wherein the pharmaceutical composition is administered to the subject subcutaneously.Claim 72: The pharmaceutical composition of claim 71, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.Claim 73: The pharmaceutical composition of claim 71, wherein the pharmaceutical composition is administered to the abdominal area of the subject.Claim 74: The pharmaceutical composition of claim 64, wherein administration of the pharmaceutical composition results in one or more of:(a) an improved total-modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score in the subject; and / or(c) an improved total Nail Psoriasis Severity Index (NAPSI) in the subject.Claim 75: The pharmaceutical composition of claim 74, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.Claim 76: The pharmaceutical composition of claim 74, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.Claim 77: The pharmaceutical composition of claim 74, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.Claim 78: The pharmaceutical composition of claim 74, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.Claim 79: The pharmaceutical composition of claim 74, wherein the total-mNAPSI is total-fingernail mNAPSI.Claim 80: The pharmaceutical composition of claim 79, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.Claim 81 : The pharmaceutical composition of claim 79, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingemail mNAPSI.Claim 82: The pharmaceutical composition of claim 81, wherein the NAPSI is total- fingemail NAPSI.Claim 83: The pharmaceutical composition of claim 82, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.Claim 84: The pharmaceutical composition of claim 82, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingemail NAPSI.Claim 85: The pharmaceutical composition of claim 82, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.Claim 86: The pharmaceutical composition of claim 74, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.Claim 87: The pharmaceutical composition of claim 64, wherein administration of the pharmaceutical composition in an improved nail pain numeric rating scale (NRS) score in the subject.Claim 88: The pharmaceutical composition of claim 87, wherein the subject has a week 0 NRS score of >3.Claim 89: The pharmaceutical composition of claim 87, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.Claim 90: The pharmaceutical composition of claim 64, wherein administration of the pharmaceutical composition results in one or more of:(a) an improved Modified Nail Psoriasis Severity Index (mNAPSI) in the subject;(b) an improved Nail Psoriasis Severity Index (NAPSI) in the subject;(c) an improved Visual medical scale to evaluate nail psoriasis severity (ViSENPsO) in the subject; and / or(d) an improved nail pain numeric rating scale (NRS) score in the subject.Claim 91: The pharmaceutical composition of claim 90, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.Claim 92: The pharmaceutical composition of claim 64, wherein administration of the pharmaceutical composition results in an increased Quality of Life (QoL) in the subject.Claim 93: The pharmaceutical composition of any of the preceding claims, wherein one or more doses of the pharmaceutical composition are administered to the subject using a ready -to-use, prefilled syringe.Claim 94: The pharmaceutical composition of claim 93, wherein the prefilled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.Claim 95: The pharmaceutical composition of claim 94, wherein the prefilled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.Claim 96: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of:(a) total-modified Nail Psoriasis Severity Index (mNAPSI);(b) Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score; and / or(c) total Nail Psoriasis Severity Index (NAPSI); in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 97: The pharmaceutical composition of claim 96, wherein the subject has a week 0 total -mNAPSI of >20 and / or a week 0 Visual medical Scale to Evaluate Nail Psoriasis severity (ViSENPsO) score of > 3.Claim 98: The pharmaceutical composition of claim 96, wherein the subject has a week 28 mNAPSI that is improved by >75% (mNAPSI 75) as compared to the subject's week 0 mNAPSI.Claim 99: The pharmaceutical composition of claim 96, wherein the subject has a week 28 mNAPSI that is improved by >90% (mNAPSI 90) as compared to the subject's week 0 mNAPSI.Claim 100: The pharmaceutical composition of claim 96, wherein the subject has a week 28 mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 mNAPSI.Claim 101: The pharmaceutical composition of claim 96, wherein the total-mNAPSI is total-fingemail mNAPSI.Claim 102: The pharmaceutical composition of claim 101, wherein the subject has a week 28 total-fingemail mNAPSI that is improved by 90% (mNAPSI 90) as compared to the subject's week 0 total-fingemail mNAPSI.Claim 103: The pharmaceutical composition of claim 101, wherein the subject has a week 28 total -fingernail mNAPSI that is improved by 100% (mNAPSI 100) as compared to the subject's week 0 total-fingernail mNAPSI.Claim 104: The pharmaceutical composition of claim 96, wherein the NAPSI is totalfingernail NAPSI.Claim 105: The pharmaceutical composition of claim 104, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 75% (NAPSI 75) as compared to the subject's week 0 total-fingemail NAPSI.Claim 106: The pharmaceutical composition of claim 104, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 90% (NAPSI 90) as compared to the subject's week 0 total-fingemail NAPSI.Claim 107: The pharmaceutical composition of claim 104, wherein the subject has a week 28 total-fingemail NAPSI that is improved by 100% (NAPSI 100) as compared to the subject's week 0 total-fingemail NAPSI.Claim 108: The pharmaceutical composition of claim 96, wherein the subject has a week 28 ViSENPsO score that decreases by a minimum of two points as compared to the subject's week 0 ViSENPsO score.Claim 109: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving nail pain numeric rating scale (NRS) score in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose ofthe pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 110: The pharmaceutical composition of claim 109, wherein the subject has a week 0 NRS score of >3.Claim 111: The pharmaceutical composition of claim 109, wherein the subject has a week 28 NRS score that is decreased by >30% as compared to the subject's week 0 NRS score.Claim 112: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for improving one or more of:(a) Modified Nail Psoriasis Severity Index (mNAPSI);(b) Nail Psoriasis Severity Index (NAPSI);(c) Visual medical scale to evaluate nail psoriasis severity (ViSENPsO); and / or(d) nail pain numeric rating scale (NRS) score; in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 113: The pharmaceutical composition of claim 112, wherein the subject has a week 28 mNAPSI, NAPSI, ViSeNPsO, and / or NRS that is improved as compared to the subject's week 0 mNAPSI, NAPSI, ViSeNPsO, and / or NRS.Claim 114: A pharmaceutical composition of an anti-IL-23pl9 antibody huml3B8-b for increasing Quality of Life (QoL) in a subject with nail psoriasis; wherein a first dose of the pharmaceutical composition is administered to the subject on week 0, a second dose of the pharmaceutical composition is administered to the subject about 4 weeks after the first dose is administered to the subject, subsequent doses of the pharmaceutical composition are administered to the subject about 16 weeks after the first dose is administered to the subject and about every 12 weeks thereafter, and a final dose of the pharmaceutical composition is administered to the subject about 52 weeks after the first dose is administered to the subject; and wherein huml3B8-b comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 115: The pharmaceutical composition of any one of claims 96 to 114, wherein the nail psoriasis is fingernail psoriasis and / or toenail psoriasis.Claim 116: The pharmaceutical composition of any one of claims 96 to 114, wherein the subject has plaque psoriasis.Claim 117: The pharmaceutical composition of any one of claims 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are the same.Claim 118: The pharmaceutical composition of claim 117, wherein the first dose, second dose, subsequent doses, and final dose are about 100 mg of huml3B8-b.Claim 119: The pharmaceutical composition of any one of claims 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg to about 250 mg of huml3B8-b.Claim 120: The pharmaceutical composition of any one of claims 96 to 114, wherein the first dose, second dose, subsequent doses, and final dose are about 5 mg, about 25 mg, about 100 mg, or about 200 mg of huml3B8-b.Claim 121: The pharmaceutical composition of any of claims 96 to 120, wherein the pharmaceutical composition is administered to the subject subcutaneously.Claim 122: The pharmaceutical composition of claim 121, wherein the pharmaceutical composition is administered to the subject by subcutaneous injection.Claim 123: The pharmaceutical composition of claim 121, wherein the pharmaceutical composition is administered to the abdominal area of the subject.Claim 124: The pharmaceutical composition of any of claims 96 to 123, wherein one or more doses of the pharmaceutical composition are administered to the subject using a ready- to-use, prefdled syringe.Claim 125: The pharmaceutical composition of claim 124, wherein the prefdled syringe contains about 100 mg ofhuml3B8-b, an excipient, and a buffer.Claim 126: The pharmaceutical composition of claim 125, wherein the prefdled syringe further comprises L-Histidine, L-Histidine Hydrochloride Monohydrate, sucrose, and Polysorbate 80.Claim 127: A method of treating nail psoriasis in a subject in need thereof, the method comprising administering a therapeutically effective amount of an antibody comprising a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

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