Methods for treating subjects with scalp psoriasis

Abstract

The present disclosure relates to the anti-IL-23p19 antibody hum13B8-b, or an antigen-binding fragment thereof, and its use in the treatment of plaque psoriasis of the scalp.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of Indian Patent Application No. 202221004128, filed on January 25, 2022, which is incorporated herein by reference in its entirety.

[0002] (Reference to Electronic Sequence Listing) This application contains an electronically submitted Sequence Listing, which is incorporated herein by reference in its entirety. The Sequence Listing was created on Jan. 23, 2023, is named "21-0347-WO_Sequence-Listing.xml" and is 11 kilobytes in size.

[0003] The present disclosure relates to an anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof, and its use in treating psoriasis vulgaris of the scalp. In some embodiments, the present disclosure relates to a method for treating psoriasis vulgaris of the scalp, wherein the treatment results in a significant improvement from the patient's baseline scores on the Investigator Global Assessment (IGA) Revised 2011 Rating Scale (scalp) score, the IGA (scalp only) score, the Scalp Itch Numeric Rating Scale (NRS) score, the Psoriasis Scalp Severity Index (PSSI) score, the Psoriasis Area and Severity Index (PASI) score, the Physician Global Assessment of Skin (PGA-S) (whole body) score, and / or the IGA Revised 2011 (whole body) score. In some embodiments, the present disclosure relates to a method for determining the efficacy of an anti-IL-23p19 antibody for treating psoriasis vulgaris of the scalp. FIELD

[0004] Psoriasis is a chronic immune-mediated inflammatory disease characterized by hyperproliferation of keratinocytes and skin-infiltrating T lymphocytes that overexpress proinflammatory mediators. The disease goes into remission and relapse throughout life, with various factors causing exacerbations in susceptible individuals. Psoriasis affects approximately 1%-2% of people worldwide, with plaque psoriasis being the most common form, affecting 80%-90% of patients.

[0005] Of those affected by psoriasis, 80% involve the scalp. Scalp psoriasis can occur alone or in conjunction with other forms of psoriasis and is characterized by red, swollen plaques with silvery-white scales that are either contained within the hairline or extend onto the forehead, ears, and back of the neck. Scalp psoriasis can be a source of great physical and social distress, with 97% of affected individuals reporting that the condition interferes with their daily lives. In many cases, it is associated with intense pruritus, and the scales typically flake off as dandruff, causing significant social embarrassment for affected individuals and may even cause hair loss. In a recent multinational survey, 43% of telephone interviews identified itch as the most bothersome symptom of psoriasis (Crowley et al., JAMA Dermatol. 151(1): 87-94 (2015)).

[0006] 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 therapies include tumor necrosis factor (TNF) antagonists, p40 (interleukin [IL]-12 and IL-23) antagonists, p19 (IL-23) antagonists, and IL-17 antagonists. Despite the availability of treatment options for psoriasis, psoriatic lesions on the scalp remain difficult to treat. Topical therapies, typically first-line therapies, are often difficult to use due to the inaccessibility of scalp lesions due to the presence of hair (Crowley, 2015 and Blakely et al., Psoriasis (Auckl.) 6: 33-40 (2016)). Patient satisfaction and compliance with topical therapies are known to be low (Devaux et al., J. Eur. Acad. Dermatol. Venereol. 26 Suppl 3: 61-67 (2012)). Thus, there remains an unmet need for effective treatment options for scalp psoriasis. Summary of the Invention

[0007] Provided herein is a method for treating plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, where a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, and where hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0008] Also provided herein is a method for the treatment of plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a reduction in the patient's Global Investigator Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to achieve "clear" or "almost clear," and wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0009] Further provided herein is a method for the treatment of plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a significant improvement in the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score from the patient's baseline score, and wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0010] Further provided herein is a method of determining efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein at week 12, or week 16, or week 52, an Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score of at least 2 points from the patient's baseline score is achieved to achieve a score of "clear" or "almost clear," indicating efficacy of the anti-IL-23p19 antibody.

[0011] Further provided herein is a method for the treatment of plaque psoriasis of the scalp comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein administration of hum13B8-b achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to achieve a score of "clear" or "almost clear."

[0012] Further provided herein is a method of determining efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein an Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score of at least 2 points from the patient's baseline score at week 52 achieving a score of "clear" or "almost clear," indicating efficacy of the anti-IL-23p19 antibody.

[0013] Further provided herein is a method of determining efficacy of an anti-IL-23p19 antibody for treating scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein at week 16, a 4 point reduction in scalp itch NRS score from the patient's baseline score indicates efficacy of the anti-IL-23p19 antibody.

[0014] Further provided herein is a method of determining efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein a PGA-S score (whole body) is reduced by at least 2 points from the patient's baseline score to achieve "clear" or "nearly clear" at week 16, indicating efficacy of the anti-IL-23p19 antibody.

[0015] Further provided herein is the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the medicament is administered subcutaneously to the patient at week 0, a second dose of the medicament is administered subcutaneously to the patient at week 4, and subsequent doses of the medicament are administered subcutaneously every 4 to 12 weeks thereafter.

[0016] It is further provided herein to manufacture a medicament for the treatment of psoriasis vulgaris of the scalp of a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the medicament achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to "clear" or "almost clear."

[0017] It is further provided herein that hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and administration of the medicament results in a significant improvement in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score from the patient's baseline score, and that the anti-IL-23p19 antibody hum13B8-b is used to manufacture a medicament for the treatment of psoriasis vulgaris of the scalp of a patient.

[0018] Further provided herein is a medicament for the treatment of psoriasis vulgaris of the scalp of a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter, and wherein administration of the drug achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0019] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously every 4 to 12 weeks thereafter.

[0020] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the pharmaceutical composition achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0021] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the pharmaceutical composition results in a significant improvement in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score from the patient's baseline score.

[0022] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein administration of the pharmaceutical composition achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0023] It is further provided herein to manufacture a medicament for the treatment of psoriasis of the scalp of a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0024] Further provided herein is a medicament for the treatment of moderate to severe scalp psoriasis in a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter, and wherein administration of the drug causes the patient to achieve a scalp Investigator Global Assessment (IGA) score of "clear" or "almost clear" at week 16, which is a reduction of at least 2 points from baseline.

[0025] It is further provided herein to manufacture a medicament for the treatment of moderate to severe scalp psoriasis in a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve clear or near clear at week 12 in an Investigator Global Assessment (IGA) score for the scalp of at least a 2 point reduction from baseline.

[0026] It is further provided herein to manufacture a medicament for the treatment of moderate to severe scalp psoriasis in a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0027] Further provided herein is a use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0028] It is further provided herein to manufacture a medicament for the treatment of moderate to severe scalp psoriasis in a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0029] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0030] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve a reduction of at least a 2 point from baseline in Investigator's Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 16.

[0031] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve a reduction in Investigator Global Assessment (IGA) score for the scalp of at least 2 points from baseline to a score of "clear" or "almost clear" at week 12.

[0032] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0033] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the antibody causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0034] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0035] Further provided herein is a method of treating scalp psoriasis comprising administering to a patient anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0036] Further provided herein is a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve a reduction from baseline in an Investigator's Global Assessment (IGA) score for the scalp of at least 2 points to a rating of "clear" or "almost clear" at week 16.

[0037] Further provided herein is a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve a reduction from baseline in an Investigator's Global Assessment (IGA) score for the scalp of at least 2 points to a score of "clear" or "almost clear" at week 12.

[0038] Further provided herein is a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve an Investigator's Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0039] Further provided herein is a method of treating moderate to severe scalp psoriasis comprising administering to a patient an anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0040] Further provided herein is a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0041] Further provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2. [Brief description of the drawings]

[0042] [Figure 1] Figure 1 is a schematic diagram showing the study design. Abbreviations: n = number of subjects in each group, R = randomized, SC = subcutaneous. [Diagram 2] Figure 2 shows the Investigator Global Assessment (IGA) Revised 2011 scale (scalp). [Diagram 3] Figure 3 shows the investigator's global assessment (IGA) (scalp only). [Figure 4] FIG. 4 is the scalp itch numeric rating scale (NRS). [Diagram 5] FIG. 5 is the Psoriasis Scalp Severity Index (PSSI). [Figure 6] Figure 6 shows the Investigator Global Assessment (IGA) Revised 2011 scale (whole body). [Figure 7] Figure 7 shows the overall skin evaluation (whole body) by a doctor. [Figure 8] Figure 8 shows the Psoriasis Area Severity Index (PASI). [Figure 9] FIG. 9 shows the Dermatology-Related Life Quality Index (DLQI). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] Before describing this disclosure in detail, a number of terms will be defined. Unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular. For example, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. As used herein, the terms "a" and "an" should be understood to refer to "one or more" of the listed components unless otherwise indicated or indicated by the context. The use of alternative expressions (e.g., "or") should be understood to mean either one, both, or any combination of the alternative expressions, unless otherwise indicated.

[0044] In this disclosure, unless otherwise indicated, any concentration range, percentage range, ratio range, or integer range should be understood to include any integer value within the recited range, and fractions thereof (such as tenths and hundredths of integers), where appropriate.

[0045] The term "about" or "approximately" means within an acceptable error range for a particular value as determined by a person skilled in the art, which depends in part on how the value is measured or determined, i.e., the limitations of the measurement system. For example, about can mean within 3 standard deviations or more than 3 standard deviations, according to the practice in the art. Alternatively, "about" can mean within 20%, preferably 10%, more preferably 5%, and even more preferably 1% of a given value. Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, more preferably within 2-fold of a value.

[0046] It should be noted that terms such as "preferably," "generally," and "typically" are not utilized herein to limit the scope of the claimed subject matter or to imply that a particular feature is critical, essential, or even essential to the structure or function of the claimed subject matter. Rather, these terms are merely intended to highlight alternative or additional features that may or may not be used in a particular embodiment of the present disclosure.

[0047] For purposes of describing and defining this disclosure, it is noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty associated with any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used to represent the extent to which a quantitative representation may vary from the stated basis without resulting in a change in the basic functionality of the subject matter.

[0048] Unless expressly specified otherwise, in the context of the present disclosure, the term "comprising" is used to indicate that in addition to the elements of the list introduced by "comprising", further elements may optionally be included. However, as a specific embodiment of the present disclosure, the term "comprising" is intended to encompass the possibility that no further elements are present, i.e., for the purposes of this embodiment, "comprising" should be understood as having the meaning of "consisting of."

[0049] As utilized in accordance with the present disclosure, unless otherwise indicated, all technical and scientific terms shall be understood to have the same meaning as commonly understood by one of ordinary skill in the art.

[0050] The present disclosure relates to the anti-IL-23p19 antibody hum13B8-b, or an antigen-binding fragment thereof, and its use in the treatment of plaque psoriasis of the scalp.

[0051] Provided herein, in some embodiments, is a method for treating psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, and wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0052] In one embodiment, the disclosure provides for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter.

[0053] In a further embodiment, the disclosure provides for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp in a patient using the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the medicament results in the patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) Revised 2011 Rating Scale (scalp) score of at least 2 points from the baseline score.

[0054] In a further embodiment, the disclosure provides a method of treating scalp psoriasis comprising administering to a patient an anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0055] In a further embodiment, the disclosure provides a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, wherein administration of hum13B8-b causes the patient to achieve a scalp Investigator Global Assessment (IGA) score of "clear" or "almost clear" at week 16, the Investigator's Global Assessment (IGA) score being reduced by at least 2 points from baseline.

[0056] In a further embodiment, the disclosure provides a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b results in the patient achieving at least a 2-point reduction from baseline in Investigator's Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 12.

[0057] In a further embodiment, the disclosure provides a method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0058] In a further embodiment, the disclosure provides a method of treating moderate to severe scalp psoriasis comprising administering to a patient an anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0059] In a further embodiment, the disclosure provides a method of treating moderate to severe scalp psoriasis comprising administering to a patient an anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0060] As utilized in accordance with this disclosure, unless otherwise indicated, all technical and scientific terms shall be understood to have the same meaning as commonly understood by those of ordinary skill in the art. Unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular.

[0061] The term "antibody" as used herein refers to a protein capable of recognizing and specifically binding to an antigen. A normal or conventional mammalian antibody comprises a tetramer, which typically consists of two identical pairs of polypeptide chains, each pair consisting of one "light chain" (typically having a molecular weight of about 25 kDa) and one "heavy chain" (typically having a molecular weight of about 50-70 kDa). The terms "heavy chain" and "light chain" as used herein refer to any immunoglobulin polypeptide having sufficient variable domain sequence to confer specificity for a target antigen. The amino-terminal portion of each light and heavy chain typically contains a variable domain of about 100-110 or more amino acids responsible for antigen recognition. The carboxyl-terminal portion of each chain typically defines a constant domain responsible for effector function. Thus, in naturally occurring antibodies, the full-length heavy chain immunoglobulin polypeptide comprises a variable domain (V H ) and three constant domains (C H1 , C H2 , and C H3 ), and CH1 and C. H2 and a hinge region between V H The domain is located at the amino terminus of the polypeptide and is C H3 The domains are at the carboxyl terminus, and full-length light chain immunoglobulin polypeptides contain a variable domain (V L ) and the constant domain (C L ), where V L The domain is located at the amino terminus of the polypeptide and is C L The domain is at the carboxyl terminus.

[0062] Within full-length light and heavy chains, the variable and constant domains are typically joined by a "J" region of about 12 or more amino acids, with the heavy chain also including a "D" region of about 10 more amino acids. The variable regions of each light / heavy chain pair typically form the antigen-binding site. The variable domains of naturally occurring antibodies typically exhibit the same general structure of relatively conserved framework regions (FR) joined by three hypervariable regions, also called complementarity determining regions or CDRs. The CDRs in the two chains of each pair are typically aligned by the framework regions, which may enable binding to a specific epitope. From the amino terminus to the carboxyl terminus, both the light and heavy chain variable domains typically include the domains FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4.

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

[0064] In a specific embodiment, the anti-IL-23p19 antibody hum13B8-b is tildrakizumab. As used herein, the term "tildrakizumab" refers to a humanized anti-IL-23p19 monoclonal antibody, also known as SCH 900222 or MK-3222. Tildrakizumab is a high affinity (297 picomolar [pM]) humanized immunoglobulin G1 / kappa (IgG1 / IL-23p40 and IL12p35 heterodimer) that specifically binds to the p19 protein of the IL-23 heterodimer but not to human IL-12 (IL-12 / 23p40 and IL12p35 heterodimer) or human IL-12 / 23p40. K ) antibody. Pharmacokinetics: The pharmacokinetics of tildrakizumab increases proportionally over the dose range of 50 mg to 200 mg (0.5 to 2 times the approved recommended dose) following subcutaneous administration in subjects with plaque psoriasis. Steady-state concentrations were achieved by week 16 following subcutaneous administration of tildrakizumab at week 0, week 4, and every 12 weeks thereafter. For the 100 mg dose at week 16, mean (±SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg / mL to 1.47 ± 1.12 mcg / mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg / mL (34%). The absolute bioavailability of tildrakizumab was estimated to be 73-80% following subcutaneous injection. Peak concentrations (Cmax) were achieved in approximately 6 days.

[0065] In some embodiments, the anti-IL-23p19 antibody tildrakizumab may refer to ILUMYA®. ILUMYA® is administered by subcutaneous injection at a recommended dose of 100 mg at week 0, week 4, and every 12 weeks thereafter. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose prefilled syringe containing 100 mg of tildrakizumab (i.e., 100 mg / mL). In some embodiments, ILUMYA® (tildrakizumab-asmn) injection for subcutaneous use is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA® is supplied in a single-dose prefilled syringe with a glass barrel and a 29-gauge fixed ½ inch needle. In some embodiments, tildrakizumab may be formulated in L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and / or sucrose in water for injection, pH 5.7-6.3. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose prefilled syringe containing 100 mg of tildrakizumab-asmn, which contains 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, pH 5.7-6.3.

[0066] In certain embodiments, 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, as disclosed in U.S. Patent Nos. 8,404,813 and 8,293,883, the disclosures of each of which are incorporated herein by reference in their entireties. In other embodiments, tildrakizumab 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 of the amino acid sequences of SEQ ID NOs:3-5, and the light chain variable domain comprises CDR1, CDR2, CDR3 of the amino acid sequences of SEQ ID NOs:6-8.

[0067] As used herein, the terms "subject" and "patient" are interchangeable. In some embodiments, a subject and / or patient is a mammal.

[0068] A "disorder" is any condition that would benefit from treatment with an antibody of the present disclosure. "Disorder" and "condition" are used interchangeably herein and include chronic and acute disorders or diseases, including pathological conditions that predispose a patient to the disorder in question.

[0069] As used herein, the term "treatment" or "treating" refers to both therapeutic treatment as well as prophylactic or preventative measures. Patients in need of treatment include those with scalp psoriasis, as well as those susceptible to scalp psoriasis or those in whom scalp psoriasis is to be prevented.

[0070] As used herein, the term "administration" or "administering" refers to providing, contacting, and / or delivering an antibody or a fragment thereof by any suitable route to achieve a desired effect. Administration may include, but is not limited to, oral administration, sublingual administration, parenteral administration (e.g., intravenous injection, subcutaneous injection, intradermal injection, intramuscular injection, intraarticular injection, intraarterial injection, intrasynovial injection, intrasternal injection, intrathecal injection, intralesional injection, or intracranial injection), transdermal administration, topical administration, buccal administration, rectal administration, intravaginal administration, intranasal administration, eye drops, inhalation, and implantation. In one embodiment, administration is performed subcutaneously via a prefilled syringe (PFS).

[0071] In some embodiments, the anti-IL-23p19 antibody hum13B8-b, or an antigen-binding fragment thereof, is administered every 2 weeks, every 4 weeks, every 6 weeks, every 8 weeks, every 10 weeks, or every 12 weeks.

[0072] As used herein, the term "week 0" refers to the first day the anti-IL-23p19 antibody hum13B8-b, or an antigen-binding fragment thereof, is administered.

[0073] In some embodiments, the anti-IL-23p19 antibody hum13B8-b, or an antigen-binding fragment thereof, is administered over a 2 week treatment period, over a 4 week treatment period, over a 6 week treatment period, over an 8 week treatment period, over a 12 week treatment period, over a 16 week treatment period, over a 20 week treatment period, over a 24 week treatment period, over a 28 week treatment period, over a 32 week treatment period, over a 36 week treatment period, over a 48 week treatment period, over a 52 week treatment period, over a 60 week treatment period, over a 72 week treatment period, or over a year or more of treatment.

[0074] The therapeutic dose or therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof will vary in part depending on the patient's body size (weight, body surface, or organ size) and condition (age and general health). In some embodiments, the patient is administered one or more doses of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof, where 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 subsequent doses of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof are the same. In some embodiments, the first dose, the second dose, and subsequent doses of the anti-IL-23p19 antibody hum13B8-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 comprise 100 mg of hum13B8-b. In some embodiments, the first dose, the second dose, and the subsequent dose comprise 200 mg of hum13B8-b.

[0075] The term "therapeutically effective amount" as applied to a dose or amount refers to an amount of a compound or pharmaceutical composition sufficient to produce a desired effect when administered to a patient in need thereof. As used herein with respect to a pharmaceutical composition comprising the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab), the term "therapeutically effective amount" also refers to a dose of a compound or pharmaceutical composition sufficient to produce an effective response when administered to a patient. In some embodiments, a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) refers to the amount required to effect a significant improvement in psoriasis of the scalp as assessed by one or more of the following: Investigator's Global Assessment (IGA) Revised 2011 Scale (scalp), Investigator's Global Assessment (scalp only) Scalp Itch Numeric Rating Scale, Scalp Surface Area, Psoriasis Scalp Severity Index, Investigator's Global Assessment (IGA) Revised 2011 Scale (whole body), Investigator's Global Assessment of Skin (whole body) Psoriasis Area and Severity Index, and / or Body Surface Area and Dermatology Related Life Quality Index. In some embodiments, a therapeutically effective amount of anti-IL-23p19 antibody hum13B8-b (i.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 anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is a dose of 100 mg. In some embodiments, a therapeutically effective amount of anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) is a dose of 100 mg at week 0, week 4, and every 12 weeks thereafter.

[0076] In various embodiments, assessment of scalp psoriasis includes, but is not limited to, Investigator Global Assessment (IGA) Revised 2011 Scale (scalp), Investigator Global Assessment (scalp only), Scalp Itch Numeric Rating Scale, Scalp Surface Area, Psoriasis Scalp Severity Index, Investigator Global Assessment (IGA) Revised 2011 Scale (total body), Physician's Global Skin Assessment (total body), Psoriasis Area and Severity Index and / or Body Surface Area, and Dermatology Related Life Quality Index.

[0077] The Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) or "IGA Revised 2011" refers to a 5-point scale that is static (referring only to the subject's condition at the time of assessment and does not attempt to compare with any of the subject's previous conditions, whether at baseline or at previous visits) (Langley et al., J. Dermatol. Treat. 26(1): 23-31 (2015)) (see FIG. 2). In some embodiments, significant improvement in scalp psoriasis as assessed by the Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) may refer to a reduction in IGA Revised 2011 (Scalp) score of at least 2 points from baseline to achieve "clear" or "almost clear" by Week 16, Week 28, Week 40, or Week 52. In some embodiments, significant improvement may refer to patients with at least a 2 point reduction in IGA Revised 2011 (Scalp) score of clear by Week 16, Week 28, Week 40, or Week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by the Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) "Clear" or "almost clear" was defined as a reduction of at least 2 points from baseline in the IGA Modified 2011 (scalp) score by Week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52. In some embodiments, significant improvement may refer to patients experiencing at least a 2 point reduction in IGA Revised 2011 (scalp) score from baseline by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0078] Investigator Global Assessment (scalp only) refers to a 5-point IGA score, which is a useful clinician assessment of scalp involvement based on thickness, erythema, and scaling. The scale defines the scores as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe (see FIG. 3). In some embodiments, significant improvement of scalp psoriasis as assessed by Investigator Global Assessment (IGA) scale (scalp only) may refer to a subject achieving a reduction of at least 2 points from baseline in the IGA Revised 2011 score (whole body) score to "clear" or "almost clear" by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by the Investigator's Global Assessment (IGA) scale (scalp only) may refer to a subject achieving at least a 2-point reduction from baseline in the IGA Revised 2011 score (total body) to "clear" or "almost clear" by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0079] The Itchy Scalp Numeric Rating Scale (Itchy Scalp NRS) refers to a self-administered single-item questionnaire with a scale of 0 = "no itching" to 10 = "worst itching imaginable". Higher scores on the NRS correspond to greater scalp itch severity (see FIG. 4). In some embodiments, significant improvement of scalp psoriasis as assessed by the Itchy Scalp NRS may refer to a subject achieving at least a 3-point reduction. In some embodiments, significant improvement of scalp psoriasis as assessed by the Itchy Scalp NRS may refer to a subject achieving a 5-point reduction from baseline in the Itchy Scalp NRS score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement of scalp psoriasis as assessed by the Itchy Scalp NRS may refer to a subject achieving a 6-point reduction from baseline in the Itchy Scalp NRS score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by Itchy Scalp NRS may refer to a subject achieving a 3, 4, 5, or 6 point reduction from baseline in Itchy Scalp NRS score by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0080] Scalp surface area (SSA) refers to scalp surface area measured using palmar method, where the palm of the subject's hand (including the palmar surface of the fingers) represents 20% of SSA.The affected areas are then calculated by their size compared to the palm of the subject's hand.In some embodiments, the significant improvement of scalp psoriasis assessed by SSA may refer to the affected scalp surface area being reduced by at least 5%, at least 10%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, or at least 75% or more from baseline by 16 weeks, 28 weeks, 40 weeks, or 52 weeks. In some embodiments, significant improvement in scalp psoriasis as assessed by SSA may refer to a reduction in affected scalp surface area from baseline of at least 5%, at least 10%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, or at least 75% or more by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0081] The Psoriasis Scalp Severity Index (PSSI) refers to a modification of the PASI, specifically assessing the severity of scalp disease. The PSSI uses a 5-point scale to grade three clinical parameters (erythema, thickness, and scaling) in the same manner as the PASI, but only on the scalp. The parameter scores are summed and multiplied by an integer (0-6) representing the area of ​​affected scalp (see FIG. 5). In some embodiments, significant improvement of scalp psoriasis as assessed by PSSI may refer to a subject having at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement of scalp psoriasis as assessed by PSSI may refer to a subject having at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement of scalp psoriasis as assessed by PSSI may refer to a subject achieving at least a 100% improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to week 16, week 28, week 40, or week 52. In some embodiments, significant improvement of scalp psoriasis as assessed by PSSI may refer to a subject achieving at least a 75%, 90%, or 100% improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to week 16, week 18, week 20, week 22, week 24, week 26, week 28, week 30, week 32, week 34, week 36, week 38, week 40, week 42, week 44, week 46, week 48, week 50, or week 52.

[0082] The Investigator Global Assessment (IGA) Scale, Revised 2011 (Global) refers to a 5-point scale that is static (referring only to the subject's condition at the time of assessment and not attempting to compare with any of the subject's previous conditions, whether at baseline or at previous visits) (Langley, 2015) (see FIG. 6). In some embodiments, significant improvement of scalp psoriasis as assessed by the Investigator Global Assessment (IGA) Scale, Revised 2011 (Global) may refer to a reduction of at least 2 points from baseline in the IGA Revised 2011 (Global) score to achieve "clear" or "almost clear" by Week 16, Week 28, Week 40, or Week 52. In some embodiments, significant improvement may refer to patients who achieve a reduction of at least 2 points from baseline in the IGA Revised 2011 (Global) score to achieve "clear" by Week 16, Week 28, Week 40, or Week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by the Investigator Global Assessment (IGA) Revised 2011 scale (total) may refer to a reduction of at least 2 points from baseline in the IGA Revised 2011 (total) score to achieve "clear" or "almost clear" by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52. In some embodiments, significant improvement may refer to patients achieving "clear" with an IGA Revised 2011 (global) score reduction of at least 2 points from baseline by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0083] The Physician's Global Assessment (PGA) of the Skin (whole body) refers to a 5-point 0-4 scale that is a useful clinician assessment of psoriasis lesions on the skin based on the degree of erythema, thickness, and scale averaged over the whole body. Each clinical sign is rated on a 0-5 scale (0=clear, 1=minimal, 2=mild, 3=moderate, and 4=severe) (see FIG. 7). In some embodiments, significant improvement of scalp psoriasis as assessed by the Physician's Global Assessment of the Skin (whole body) may refer to a subject achieving a PGA of the Skin (whole body) score of "clear" or "almost clear" by week 16, week 28, week 40, or week 52, with a reduction of at least 2 points from baseline. In some embodiments, significant improvement of scalp psoriasis as assessed by the Physician's Global Assessment of the Skin (whole body) may refer to a subject achieving a PGA of the Skin (whole body) score of "clear" by week 16, week 28, week 40, or week 52, with a reduction of at least 2 points from baseline. In some embodiments, significant improvement in scalp psoriasis as assessed by a physician's global skin (total) assessment may refer to a subject achieving at least a 2 point reduction from baseline in the PGA Skin (total) score to "clear" or "almost clear" by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52. In some embodiments, significant improvement in scalp psoriasis as assessed by a physician's global skin (total) assessment may refer to a subject achieving at least a 2 point reduction from baseline in the PGA Skin (total) score to "clear" by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0084] The Psoriasis Area and Severity Index (PASI) is used to determine treatment success (PASI 75, PASI 90, and PASI 100) in subjects with scalp psoriasis. PASI includes scores for erythema, thickness, scaling, and percent of body surface area (BSA) affected (see FIG. 8). In some embodiments, significant improvement in scalp psoriasis as assessed by PASI may refer to a subject achieving at least a 75% improvement from baseline in PASI score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by PASI may refer to a subject achieving at least a 90% improvement from baseline in PASI score by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by PASI may refer to a subject achieving at least a 100% improvement in PASI score from baseline by week 16, week 28, week 40, or week 52. In some embodiments, significant improvement in scalp psoriasis as assessed by PASI may refer to a subject achieving at least a 75%, 90%, or 100% improvement in PASI score from baseline by week 16, week 18, week 20, week 22, week 24, week 26, week 28, week 30, week 32, week 34, week 36, week 38, week 40, week 42, week 44, week 46, week 48, week 50, or week 52.

[0085] Body surface area is commonly used to measure the severity of skin diseases. It is defined as the percentage of total BSA affected by psoriasis, and represents the affected scalp area. BSA is measured using palmar method, where the palm of the subject's hand (including the palmar surface of the fingers) represents 1% of BSA. The affected area is then calculated by its size compared to the palm of the subject's hand. In some embodiments, the significant improvement of scalp psoriasis assessed by body surface area can refer to a reduction of affected body surface area by at least 5%, at least 10%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, or at least 75% or more from baseline by 16 weeks, 28 weeks, 40 weeks, or 52 weeks. In some embodiments, significant improvement in scalp psoriasis as assessed by body surface area may refer to a reduction in affected body surface area from baseline of at least 5%, at least 10%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, or at least 75% or more by week 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, or 52.

[0086] The Dermatology Related Life Quality Index (DLQI) questionnaire is used to assess the effectiveness of treatment on the subject's quality of life. The DLQI is a 10-item questionnaire that measures the impact of a skin condition on the participant's quality of life. Each question is rated on a 4-point scale ranging from 0 (not at all) to 3 (very much), with higher scores indicating a greater impact on quality of life. The total score ranges from 0 (not at all) to 30 (very much). Scores 0-1 = no impact on the participant's life at all, scores 2-6 = little impact on the participant's life, scores 7-12 = moderate impact on the participant's life, scores 13-18 = very much impact on the participant's life, and scores 19-30 = enormous impact on the participant's life. The higher the score, the greater the impact on the participant's quality of life. The purpose of this questionnaire is to measure the extent to which a skin condition has impacted the subject's life during the past week. The subject is asked to recall their experiences during the past week by answering 10 questions (see Figure 9). In some embodiments, significant improvement in scalp psoriasis as assessed by DLQI may refer to a positive change of 2, 3, 4, 5, 6, 7, 8, 9, or 10 or more from baseline in DLQI score by week 16, week 28, week 40, or week 52.

[0087] As used herein, the term "significant improvement" refers to a significant positive effect in the response of patients receiving anti-IL-23p19 antibody hum13B8-b, including anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab), compared to patients receiving a placebo. In some embodiments, significant improvement in scalp psoriasis may be assessed by one or more of the following: Investigator's Global Assessment (IGA) Revised 2011 Scale (scalp), Investigator's Global Assessment (scalp only), Scalp Itch Numeric Rating Scale, Scalp Surface Area, Psoriasis Scalp Severity Index, Investigator's Global Assessment (IGA) Revised 2011 Scale (whole body), Investigator's Global Assessment of Skin (whole body), Psoriasis Area and Severity Index, and / or Body Surface Area and Dermatology-Related Life Quality Index. In certain embodiments, significant improvement refers to a statistically significant improvement. In certain embodiments, the term statistically significant means having less than a 10% probability under the relevant null hypothesis (i.e., p<0.1). In some embodiments, a p-value less than 0.05 is considered statistically significant. In some embodiments, a p-value less than 0.01 is considered statistically significant. In some embodiments, a p-value less than 0.005 is considered statistically significant. In some embodiments, a p-value less than 0.0025 is considered statistically significant. In some embodiments, a p-value less than 0.001 is considered statistically significant. In certain embodiments, the statistical test is two-sided at the 5% significance level, and the point estimates are accompanied by 95% confidence intervals (CIs) on both sides, where applicable.

[0088] In some embodiments, significant improvement may refer to at least a 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 150%, or 200% or more improvement in scalp psoriasis as assessed by one or more of the Investigator's Global Assessment (IGA) Revised 2011 Scale (scalp), Investigator's Global Assessment (scalp only), Scalp Itch Numeric Rating Scale, Scalp Surface Area, Psoriasis Scalp Severity Index, Investigator's Global Assessment (IGA) Revised 2011 Scale (whole body), Physician's Global Assessment of Skin (whole body), Psoriasis Area and Severity Index, and / or Body Surface Area and Dermatology Related Life Quality Index.

[0089] In some embodiments, significant improvement may refer to at least a 2-fold, 3-fold, 4-fold, 5-fold, or greater than 10-fold improvement in scalp psoriasis as assessed by one or more of the following: Investigator Global Assessment (IGA) Revised 2011 Scale (scalp), Investigator Global Assessment (scalp only) Scalp Itch Numeric Rating Scale, Scalp Surface Area, Psoriasis Scalp Severity Index, Investigator Global Assessment (IGA) Revised 2011 Scale (whole body), Physician Global Assessment of Skin (whole body), Psoriasis Area and Severity Index, and / or Body Surface Area and Dermatology Related Life Quality Index.

[0090] Provided herein, in some embodiments, is a method for the treatment of plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a reduction in the patient's Global Investigator Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to achieve "clear" or "almost clear," and wherein the antibody hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0091] Provided herein, in some embodiments, is a method for treating psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is administered a first dose of hum13B8-b subcutaneously at week 0, a second dose of hum13B8-b subcutaneously at week 4, and subsequent doses of hum13B8-b every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0092] In a further embodiment, there is provided herein a use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein administration of the medicament achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to "clear" or "almost clear."

[0093] In other embodiments, use of the agent results in further improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0094] In other embodiments, the use of the agent further results in at least a 90% improvement from the patient's baseline score on the Psoriasis Scalp Severity Index (PSSI).

[0095] In a further embodiment, the disclosure provides the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and administration of the medicament achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to "clear" or "nearly clear."

[0096] Provided herein, in some embodiments, is a method for the treatment of plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a significant improvement from the patient's baseline score on the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score, and wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0097] In a further embodiment herein there is provided the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and administration of the agent results in a significant improvement from the patient's baseline score on the Revised 2011 Investigator's Global Assessment (IGA) scale (scalp) score.

[0098] In other embodiments, use of the agent results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0099] In other embodiments, use of the agent further results in at least about a 70%, 75%, 80%, 85%, 90%, 95%, 100%, 150%, or 200% or more improvement from the patient's baseline score in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0100] In other embodiments, the use of the agent further results in at least a 90% improvement from the patient's baseline score on the Psoriasis Scalp Severity Index (PSSI).

[0101] In a further embodiment, the present invention provides the use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and administration of the medicament results in a significant improvement from the patient's baseline score on the Revised 2011 Investigator's Global Assessment (IGA) scale (scalp) score.

[0102] As used herein, in some embodiments, a method for treating IL-23p19 disease includes administering a therapeutically effective amount of an anti-IL-23p19 antibody, hum13B8-b, to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2. and a peptide, wherein the efficacy of hum13B8-b is demonstrated by achieving an IGA Revised 2011 (scalp) score of "clear" or "almost clear" at week 12, or at week 16, or at week 20, or at week 24, or at week 28, or at week 32, or at week 36, or at week 40, or at week 44, or at week 48, or at week 52 in an IGA Revised 2011 (scalp) score of at least 2 points from the patient's baseline score.

[0103] Provided herein, in some embodiments, is a method of determining efficacy of an anti-IL-23p19 antibody for treating psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the antibody hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein at week 52 an IGA (scalp) score of at least 2 points from the baseline score achieving "clear" and "almost clear" indicates efficacy of the antibody.

[0104] Provided herein, in some embodiments, is a method of determining efficacy of an anti-IL-23p19 antibody for treating psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, where a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, where hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein at week 16, a reduction in Scalp Itch NRS score of 4 points from the patient's baseline score indicates efficacy of the antibody.

[0105] Provided herein, in some embodiments, is a method of determining efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering to a patient in need thereof a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein at week 16, a PGA-S score (total) is reduced by at least 2 points from the patient's baseline score to achieve "clear" or "nearly clear," indicating efficacy of the anti-IL-23p19 antibody.

[0106] As used herein, the term "pharmaceutical composition" or "therapeutic composition" refers to a compound or composition capable of inducing a desired therapeutic effect when properly administered to a patient. One embodiment of the present disclosure provides a pharmaceutical composition comprising a pharma- ceutical acceptable carrier and a therapeutically effective amount of at least one antibody of the present disclosure.

[0107] As used herein, the term "pharmaceutically acceptable carrier" or "physiologically acceptable carrier" refers to one or more formulation materials suitable for achieving or enhancing delivery of one or more antibodies of the present disclosure.

[0108] Provided herein are pharmaceutical compositions that contain tildrakizumab alone or in combination with a preventive agent, a therapeutic agent, and / or a pharmaceutically acceptable carrier. The pharmaceutical compositions provided herein that contain tildrakizumab are intended for, but are not limited to, the diagnosis, detection, or monitoring of a disorder, the prevention, treatment, management, or amelioration of a disorder or one or more symptoms thereof, and / or for use in research. The formulation of pharmaceutical compositions alone or in combination with a preventive agent, a therapeutic agent, and / or a pharmaceutically acceptable carrier is known to those skilled in the art.

[0109] Provided herein in some embodiments is a pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for treating psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0110] Further provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter.

[0111] Further provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the pharmaceutical composition achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0112] Herein, in some embodiments, there is provided a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and administration of the pharmaceutical composition results in a significant improvement in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score from the patient's baseline score.

[0113] Further provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein administration of the pharmaceutical composition achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0114] Provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition results in the patient achieving a scalp Investigator Global Assessment (IGA) score of at least 2 points from baseline to a score of "clear" or "almost clear" at week 16.

[0115] Provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition results in the patient achieving a reduction from baseline in an Investigator Global Assessment (IGA) score for the scalp of at least 2 points to a score of "clear" or "almost clear" at week 12.

[0116] Provided herein in some embodiments is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition results in the patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0117] In some embodiments, provided herein is a pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the antibody causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0118] Herein, in some embodiments, a method of a pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0119] Embodiment Embodiment 1 A method is provided for the treatment of psoriasis vulgaris of the scalp comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0120] Embodiment 2. The method of embodiment 1, wherein the first dose, the second dose, and the subsequent doses are the same.

[0121] Embodiment 3. The method of embodiment 2, wherein the first dose, the second dose, and any subsequent doses are 100 mg.

[0122] Embodiment 4. The method of embodiment 1, wherein subsequent doses are administered every 12 weeks, for at least 16 weeks.

[0123] Embodiment 5. The method of embodiment 1, wherein subsequent doses are administered every 4 weeks for at least 28 weeks.

[0124] Embodiment 6 The method of embodiment 1, wherein subsequent doses are administered to the patient every 12 weeks for at least up to 40 weeks, up to 52 weeks, up to 72 weeks, or longer.

[0125] Embodiment 7 A method is provided for the treatment of plaque psoriasis of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a reduction in the patient's Global Investigator Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from their baseline score to achieve "clear" or "almost clear," and wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0126] Embodiment 8 The method of embodiment 7, wherein administration of hum13B8-b results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0127] Embodiment 9. A method for the treatment of plaque psoriasis of the scalp comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a significant improvement from the patient's baseline score in the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0128] Embodiment 10 The method of embodiment 9, wherein administration of humB13B-b results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (scalp only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0129] Embodiment 11. A method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of plaque psoriasis of the scalp comprising administering to a patient in need thereof a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein the efficacy of the anti-IL-23p19 antibody is indicated by a reduction of at least 2 points from the patient's baseline score on the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score of "clear" or "almost clear" at week 12, or week 16, or week 52.

[0130] Embodiment 12. The method of embodiment 11, further demonstrating efficacy of the anti-IL-23p19 antibody by improving the Psoriasis Scalp Severity Index (PSSI) by at least 90% from the patient's baseline score at week 12, or week 16, or week 52.

[0131] Embodiment 13. A method for the treatment of plaque psoriasis of the scalp comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein administration of hum13B8-b achieves a "clear" or "almost clear" Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (scalp) score that is not reduced by at least 2 points from the patient's baseline score.

[0132] Embodiment 14 The method of embodiment 13, wherein administration of hum13B8-b results in a further significant improvement in the Psoriasis Scalp Severity Index (PSSI) from the patient's baseline score.

[0133] Embodiment 15. The method of any of embodiments 13 or 14, wherein the first dose, the second dose, and the subsequent doses are the same.

[0134] Embodiment 16. The method of embodiment 15, wherein the first dose, the second dose, and any subsequent doses are 100 mg.

[0135] Embodiment 17. A method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of plaque psoriasis of the scalp comprising administering to a patient in need thereof a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein an Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score of at least 2 points from the patient's baseline score achieving a score of "clear" or "almost clear" at week 52 indicates efficacy of the anti-IL-23p19 antibody.

[0136] Embodiment 18. The method of embodiment 17, wherein the Psoriasis Scalp Severity Index (PSSI) at week 52 provides a significant improvement from the patient's baseline score, further demonstrating efficacy of the anti-IL-23p19 antibody.

[0137] Embodiment 19. The method of embodiment 17, further demonstrating efficacy of the anti-IL-23p19 antibody by improving the Psoriasis Scalp Severity Index (PSSI) by at least 75% from the patient's baseline score at week 52.

[0138] Embodiment 20. A method of determining the efficacy of an anti-IL-23p19 antibody for treating psoriasis vulgaris of the scalp comprising administering to a patient in need thereof a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein at week 16, a reduction in Scalp Itch NRS score of 4 points from the patient's baseline score indicates efficacy of the anti-IL-23p19 antibody.

[0139] Embodiment 21 A method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein at week 0, a first dose of hum13B8-b is administered subcutaneously to the patient, at week 4, a second dose of hum13B8-b is administered subcutaneously to the patient, and every 4 to 12 weeks thereafter, subsequent doses of hum13B8-b are administered subcutaneously to the patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein at week 16, a PGA-S score (total) reduction of at least 2 points from the patient's baseline score to achieve "clear" or "nearly clear" indicates efficacy of the anti-IL-23p19 antibody.

[0140] Embodiment 22. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter.

[0141] Embodiment 23. The use of embodiment 22, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug are the same.

[0142] Embodiment 24. The use of embodiment 23, wherein the first dose of drug, the second dose of drug, and any subsequent doses of drug contain 100 mg of hum13B8-b.

[0143] Embodiment 25. The use of embodiment 22, wherein subsequent doses of the agent are administered every 12 weeks for up to at least 16 weeks.

[0144] Embodiment 26. The use of embodiment 22, wherein subsequent doses of the agent are administered every 4 weeks for up to at least 28 weeks.

[0145] Embodiment 27 The use of embodiment 22, wherein subsequent doses of the agent are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

[0146] Embodiment 28. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein administration of the agent achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0147] Embodiment 29 The use of embodiment 28, wherein administration of the agent results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0148] Embodiment 30. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of plaque psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the medicament results in a significant improvement from the patient's baseline score on the Revised 2011 Investigator Global Assessment (IGA) scale (scalp) score.

[0149] Embodiment 31 The use of embodiment 30, wherein administration of the agent results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0150] Embodiment 32. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of plaque psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered subcutaneously to the patient at week 0, a second dose of the drug is administered subcutaneously to the patient at week 4, and subsequent doses of the drug are administered subcutaneously to the patient every 4 to 12 weeks thereafter, and wherein administration of the drug results in a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score to achieve a score of "clear" or "almost clear."

[0151] Embodiment 33. The use according to embodiment 32, wherein administration of the agent results in a further significant improvement from the patient's baseline score in the Psoriasis Scalp Severity Index (PSSI).

[0152] Embodiment 34. The use of any of embodiments 32 or 33, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug are the same.

[0153] Embodiment 35. The use of embodiment 34, wherein the first dose of drug, the second dose of drug, and any subsequent doses of drug contain 100 mg of hum13B8-b.

[0154] Embodiment 36. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter.

[0155] Embodiment 37. The pharmaceutical composition of embodiment 36, wherein the pharmaceutical composition of the first dose, the pharmaceutical composition of the second dose, and the pharmaceutical composition of the subsequent dose are the same.

[0156] Embodiment 38. The pharmaceutical composition of embodiment 36, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent doses of the pharmaceutical composition contain 100 mg of hum13B8-b.

[0157] Embodiment 39. The pharmaceutical composition of embodiment 36, wherein subsequent doses of the pharmaceutical composition are administered every 12 weeks for up to at least 16 weeks.

[0158] Embodiment 40. The pharmaceutical composition of embodiment 36, wherein subsequent doses of the pharmaceutical composition are administered every 4 weeks for up to at least 28 weeks.

[0159] Embodiment 41 The pharmaceutical composition of embodiment 36, wherein subsequent doses of the pharmaceutical composition are administered every 12 weeks for up to at least 40 weeks, up to at least 52 weeks, up to at least 72 weeks, or more.

[0160] Embodiment 42. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein administration of the pharmaceutical composition achieves a reduction in the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear" from the patient's baseline score of at least 2 points.

[0161] Embodiment 43 The pharmaceutical composition of embodiment 42, wherein administration of the pharmaceutical composition results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0162] Embodiment 44. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and wherein administration of the pharmaceutical composition results in a significant improvement from the patient's baseline score on the Revised 2011 Investigator Global Assessment (IGA) scale (scalp) score.

[0163] Embodiment 45 The pharmaceutical composition of embodiment 44, wherein administration of the pharmaceutical composition results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

[0164] Embodiment 46. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein administration of the pharmaceutical composition achieves a "clear" or "almost clear" Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score.

[0165] Embodiment 47. The pharmaceutical composition of embodiment 46, wherein administration of the pharmaceutical composition results in a further significant improvement from the patient's baseline score in the Psoriasis Scalp Severity Index (PSSI).

[0166] Embodiment 48. The pharmaceutical composition of either embodiment 46 or 47, wherein the pharmaceutical composition of the first dose, the pharmaceutical composition of the second dose, and the pharmaceutical composition of the subsequent dose are the same.

[0167] Embodiment 49. The pharmaceutical composition of embodiment 48, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent doses of the pharmaceutical composition contain 100 mg of hum13B8-b.

[0168] Embodiment 50. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0169] Embodiment 51. The use according to embodiment 50, wherein the psoriasis of the scalp is moderate to severe psoriasis of the scalp.

[0170] Embodiment 52. The use of embodiment 50, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0171] Embodiment 53. The use of embodiment 52, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug are the same.

[0172] Embodiment 54. The use of embodiment 53, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug contain 100 mg of hum13B8-b.

[0173] Embodiment 55. The use of embodiment 52, wherein subsequent doses of the agent are administered every 12 weeks for up to at least 16 weeks.

[0174] Embodiment 56. The use of embodiment 52, wherein subsequent doses of the agent are administered every 4 weeks for up to at least 28 weeks.

[0175] Embodiment 57. The use of embodiment 52, wherein subsequent doses of the agent are administered every 12 weeks for at least up to 40 weeks, at least up to 52 weeks, at least up to 72 weeks, or more.

[0176] Embodiment 58. The use of embodiment 50, wherein the medicament is administered to the patient by subcutaneous injection.

[0177] Embodiment 59. The use of embodiment 50, wherein the patient has an affected scalp surface area (SSA) of at least 50%, a Psoriasis Area and Severity Index (PASI) score of at least 16.7, and / or a Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe).

[0178] Embodiment 60. The use of embodiment 50, wherein the patient is male, Caucasian, and / or at least 44 years old.

[0179] Embodiment 61 The use of embodiment 50, wherein administration of the agent results in a patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at Week 16, with a reduction of at least 2 points from baseline.

[0180] Embodiment 62. The use of embodiment 50, wherein administration of the agent results in the patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at Week 12 with a reduction of at least 2 points from baseline.

[0181] Embodiment 63. The use of embodiment 50, wherein administration of the agent results in the patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at Week 12.

[0182] Embodiment 64. The use according to embodiment 50, wherein administration of the medicament results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0183] Embodiment 65. The use of embodiment 50, wherein administration of the agent results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0184] Embodiment 66. Use of anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a reduction from baseline in an Investigator's Global Assessment (IGA) score for the scalp of at least 2 points to a score of "clear" or "almost clear" at week 16.

[0185] Embodiment 67. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a reduction of at least a 2 point from baseline in Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 12.

[0186] Embodiment 68. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0187] Embodiment 69. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0188] Embodiment 70. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0189] Embodiment 71. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0190] Embodiment 72. The pharmaceutical composition of embodiment 71, wherein the psoriasis of the scalp is moderate to severe psoriasis of the scalp.

[0191] Embodiment 73. The pharmaceutical composition of embodiment 71, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter.

[0192] Embodiment 74. The pharmaceutical composition of embodiment 73, wherein the pharmaceutical composition of the first dose, the pharmaceutical composition of the second dose, and the pharmaceutical composition of the subsequent dose are the same.

[0193] Embodiment 75. The pharmaceutical composition of embodiment 74, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent doses of the pharmaceutical composition contain 100 mg of hum13B8-b.

[0194] Embodiment 76. The pharmaceutical composition of embodiment 73, wherein subsequent doses of the pharmaceutical composition are administered every 12 weeks for up to at least 16 weeks.

[0195] Embodiment 77. The pharmaceutical composition of embodiment 73, wherein subsequent doses of the pharmaceutical composition are administered every 4 weeks for up to at least 28 weeks.

[0196] Embodiment 78. The pharmaceutical composition of embodiment 73, wherein the subsequent doses of the pharmaceutical composition are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

[0197] Embodiment 79. The pharmaceutical composition of embodiment 71, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.

[0198] Embodiment 80. The pharmaceutical composition of embodiment 71, wherein the patient has an affected scalp surface area (SSA) of at least 50%, a Psoriasis Area and Severity Index (PASI) score of at least 16.7, and / or a Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe).

[0199] Embodiment 81. The pharmaceutical composition of embodiment 71, wherein the patient is male, Caucasian, and / or at least 44 years old.

[0200] Embodiment 82. The pharmaceutical composition of embodiment 71, wherein administration of the pharmaceutical composition results in a patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at Week 16 with a reduction of at least 2 points from baseline.

[0201] Embodiment 83. The pharmaceutical composition of embodiment 71, wherein administration of the pharmaceutical composition results in a patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at Week 12 with a reduction of at least 2 points from baseline.

[0202] Embodiment 84. The pharmaceutical composition of embodiment 71, wherein administration of the pharmaceutical composition results in a patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at Week 12.

[0203] Embodiment 85. The pharmaceutical composition of embodiment 71, wherein administration of the pharmaceutical composition results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0204] Embodiment 86. The pharmaceutical composition of embodiment 71, wherein administration of the pharmaceutical composition results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0205] Embodiment 87. A pharmaceutical composition method of anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve a reduction of at least a 2 point from baseline in Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 16.

[0206] Embodiment 88. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve a reduction of at least a 2 point from baseline in Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 12.

[0207] Embodiment 89. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0208] Embodiment 90. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the antibody causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0209] Embodiment 91 A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the treatment of moderate to severe psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the pharmaceutical composition is administered to the patient at week 0, a second dose of the pharmaceutical composition is administered to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered to the patient every 4 to 12 weeks thereafter, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection, and wherein administration of the pharmaceutical composition causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0210] Embodiment 92. A method of treating psoriasis of the scalp comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0211] Embodiment 93. The method of embodiment 92, wherein the psoriasis of the scalp is moderate to severe psoriasis of the scalp.

[0212] Embodiment 94 The method of embodiment 92, wherein a therapeutically effective amount of hum13B8-b is administered to the patient.

[0213] Embodiment 95. The method of embodiment 92, wherein the patient is administered a first dose of hum13B8-b at week 0, a second dose of hum13B8-b at week 4, and subsequent doses of hum13B8-b every 4 to 12 weeks thereafter.

[0214] Embodiment 96. The method of embodiment 95, wherein the first dose, the second dose and the subsequent doses are the same.

[0215] Embodiment 97. The method of embodiment 96, wherein the first dose, the second dose and any subsequent doses are 100 mg.

[0216] Embodiment 98. The method of embodiment 95, wherein the subsequent doses are administered every 12 weeks for up to at least 16 weeks.

[0217] Embodiment 99. The method of embodiment 95, wherein subsequent doses are administered every 4 weeks for up to at least 28 weeks.

[0218] Embodiment 100. The method of embodiment 95, wherein the subsequent doses are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

[0219]

[0046] Embodiment 101. The method of embodiment 92, wherein the antibody is administered to the patient by subcutaneous injection.

[0220] Embodiment 102 The method of embodiment 92, wherein the patient has an affected scalp surface area (SSA) of at least 50%, a Psoriasis Area and Severity Index (PASI) score of at least 16.7, and / or a Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe).

[0221] Embodiment 103. The method of embodiment 92, wherein the patient is male, Caucasian, and / or at least 44 years of age.

[0222] Embodiment 104. The method of embodiment 92, wherein administration of the antibody results in the patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score reduction of at least 2 points from baseline for the scalp at week 16.

[0223] Embodiment 105. The method of embodiment 92, wherein administration of the antibody results in the patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score of at least 2 points from baseline for the scalp at week 12.

[0224] Embodiment 106. The method of embodiment 92, wherein administration of the antibody results in the patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at Week 12.

[0225] Embodiment 107. The method of embodiment 92, wherein administration of the antibody results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0226] Embodiment 108. The method of embodiment 92, wherein administration of the antibody results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0227] Embodiment 109. A method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b results in the patient achieving at least a 2-point reduction from baseline in an Investigator's Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 16.

[0228] Embodiment 110. A method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein the administration of hum13B8-b results in the patient achieving a scalp Investigator's Global Assessment (IGA) score of at least 2 points from baseline to a score of "clear" or "almost clear" at week 12.

[0229] Embodiment 111. A method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, wherein administration of hum13B8-b causes the patient to achieve an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0230] A method of treating moderate to severe scalp psoriasis comprising administering to a patient an anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1 and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0231] Embodiment 113. A method of treating moderate to severe scalp psoriasis comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of hum13B8-b is administered to the patient at week 0, a second dose of hum13B8-b is administered to the patient at week 4, and subsequent doses of hum13B8-b are administered to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b is administered to the patient by subcutaneous injection, and wherein administration of hum13B8-b causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0232] Embodiment 114. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis of the scalp of a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2.

[0233] Embodiment 115. The pharmaceutical composition of embodiment 114, wherein the scalp psoriasis is moderate to severe scalp psoriasis.

[0234] Embodiment 116. The pharmaceutical composition of embodiment 114, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter.

[0235] Embodiment 117. The pharmaceutical composition of embodiment 116, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug are the same.

[0236] Embodiment 118. The pharmaceutical composition of embodiment 117, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug contain 100 mg of hum13B8-b.

[0237] Embodiment 119. The pharmaceutical composition of embodiment 116, wherein subsequent doses of the agent are administered every 12 weeks for up to at least 16 weeks.

[0238] Embodiment 120. The pharmaceutical composition of embodiment 116, wherein subsequent doses of the drug are administered every 4 weeks for up to at least 28 weeks.

[0239] Embodiment 121 The pharmaceutical composition of embodiment 116, wherein subsequent doses of the agent are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

[0240] Embodiment 122. The pharmaceutical composition of embodiment 114, wherein the medicament is administered to the patient by subcutaneous injection.

[0241] Embodiment 123. The pharmaceutical composition of embodiment 114, wherein the patient has an affected scalp surface area (SSA) of at least 50%, a Psoriasis Area and Severity Index (PASI) score of at least 16.7, and / or a Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe).

[0242] Embodiment 124. The pharmaceutical composition of embodiment 114, wherein the patient is male, Caucasian, and / or at least 44 years old.

[0243] Embodiment 125. The pharmaceutical composition of embodiment 114, wherein administration of the agent results in a patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at Week 16 with a reduction of at least 2 points from baseline.

[0244] Embodiment 126. The pharmaceutical composition of embodiment 114, wherein administration of the agent results in a patient achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) score for the scalp at week 12 with a reduction of at least 2 points from baseline.

[0245] Embodiment 127. The pharmaceutical composition of embodiment 114, wherein administration of the agent results in a patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at 12 weeks.

[0246] Embodiment 128. The pharmaceutical composition of embodiment 114, wherein administration of the agent results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0247] Embodiment 129. The pharmaceutical composition of embodiment 114, wherein administration of the agent results in the patient achieving a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12.

[0248] Embodiment 130. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a reduction of at least a 2-point from baseline in Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" at week 16.

[0249] Embodiment 131 A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of drug is administered to the patient at week 0, a second dose of drug is administered to the patient at week 4, and subsequent doses of drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a reduction from baseline in an Investigator's Global Assessment (IGA) score for the scalp of at least 2 points to be "clear" or "almost clear" at week 12.

[0250] Embodiment 132. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, wherein said second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug results in the patient achieving an Investigator Global Assessment (IGA) scalp response rate of 0 (clear) or 1 (almost clear) at week 12.

[0251] Embodiment 133. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 16.

[0252] Embodiment 134. A pharmaceutical composition of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of moderate to severe scalp psoriasis in a patient, wherein hum13B8-b comprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein a first dose of the drug is administered to the patient at week 0, a second dose of the drug is administered to the patient at week 4, and subsequent doses of the drug are administered to the patient every 4 to 12 weeks thereafter, wherein the drug is administered to the patient by subcutaneous injection, and wherein administration of the drug causes the patient to achieve a Psoriasis Scalp Severity Index (PSSI) of 90 at week 12. EXAMPLES

[0253] The following examples are illustrative of certain embodiments of the present disclosure and various uses thereof. They are provided for illustrative purposes only and should not be construed as limiting the scope of the disclosure in any way.

[0254] Example 1: Administration of Tildrakizumab in Subjects with Plaque Psoriasis of the Scalp - Proposed Phase III Study This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp.

[0255] Subjects were enrolled in the study if they had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, had moderate to severe plaque psoriasis at screening with baseline (Investigator Global Assessment [IGA Revised 2011 (scalp)]) ≥3, Psoriasis Scalp Severity Index [PSSI] score ≥12, and ≥30% scalp surface area involved, and had moderate to severe plaque psoriasis at screening with baseline (IGA Revised 2011 (total) ≥3, Psoriasis Area and Severity Index [PASI] score ≥12, and body surface area [BSA] involvement ≥10% and were considered candidates for systemic therapy (NCT03897088).

[0256] After a 28-day screening period, all 231 subjects were randomly assigned (in a 1:1 ratio after stratification according to previous use of TNF-alpha inhibitors and baseline body weight [≤90 kg or >90 kg]) on day 1 to receive either tildrakizumab 100 mg or placebo by subcutaneous (SC) injection at weeks 0 (day 1) and 4. Subjects received their first dose of study treatment within 24 hours of randomization.

[0257] Between weeks 16 and 52, subjects originally randomized to placebo were switched to tildrakizumab, receiving 100 mg at weeks 16, 20, 32, and 44. Subjects originally randomized to tildrakizumab 100 mg continued to receive tildrakizumab at weeks 16, 28, 40, and 52. To maintain blinding, subjects in both treatment arms received corresponding placebo injections at the designated time points as described in the Schedule of Activities (SoA).

[0258] After week 52 (or early termination of study treatment before week 52), study treatment was stopped and subjects entered a 20-week observational safety follow-up period after the last dose of study treatment. During the follow-up period, subjects continued only study-approved concomitant medications, but may be placed on other appropriate therapies for safety concerns or significant worsening of psoriasis, based on the investigator's judgment. Subjects did not receive study treatment during the follow-up period.

[0259] The disease activity (response to study treatment) of subjects was evaluated using IGA revised 2011 (scalp), PSSI, PASI, IGA (scalp only), PGA-S (whole body), IGA revised 2011 (whole body), scalp itch numeric rating scale (NRS), BSA, and Dermatology-related Life Quality Index (DLQI) score.The results are shown in the following examples and tables.

[0260] 1. Number of subjects The study randomized 231 subjects with moderate to severe psoriasis of the scalp to be treated with tildrakizumab 100 mg (n=117) or placebo (n=114) in one group.

[0261] 2. Treatment group and duration The study period per subject was approximately 18 to 19 months, and the total study period was approximately 2.5 years.

[0262] The study consisted of a 28-day screening period, a 52-week treatment period (a 16-week double-blind placebo-controlled treatment period followed by a 36-week double-blind active treatment period), and a 20-week observational safety follow-up period.

[0263] Part 1 (Day 1-Week 16) Double-blind, placebo-controlled, subjects received either tildrakizumab 100 mg (Group A, n=117) or placebo (Group B, n=114) by SC injection at weeks 0 and 4. The treatment period for double-blind Part 1 of the study was 16 weeks, and efficacy and safety evaluations were conducted at week 16.

[0264] Part 2 (Weeks 16-52): At week 16, subjects initially randomized to placebo were switched to receive tildrakizumab 100 mg at weeks 16, 20, 32, and 44. Subjects initially randomized to tildrakizumab 100 mg continued to receive active agent at weeks 16, 28, 40, and 52. To maintain blinding, subjects in both treatment arms received corresponding placebo injections at the designated time points. Efficacy and safety assessments were conducted on the day of injection at week 16 and before injection at week 52 or after the day of injection (or first injection before week 52) plus 28 days.

[0265] Part 3 (Weeks 52-72): After week 52 (or early termination of study treatment before week 52), subjects entered a 20-week observational safety follow-up period in which tildrakizumab treatment was discontinued. Safety assessments were conducted for 20 weeks after the week 52 injection date (or last injection, or early termination of Parts 1 and 2 before week 52).

[0266] 3. Statistical methods The primary efficacy outcome measure in this study was the proportion of subjects with a clear or almost clear IGA Revised 2011 (scalp) score of at least 2 points from baseline at week 16. Key secondary efficacy outcomes were the proportion of subjects with at least 90% improvement in PSSI (PSSI90) from baseline at week 16, the proportion of subjects achieving clear and almost clear with at least 2 points reduction in IGA (scalp only) score from baseline at week 16, the proportion of subjects achieving clear and almost clear with at least 2 points reduction in IGA Revised 2011 (scalp) score from baseline at week 12, and the proportion of subjects achieving at least 90% improvement in PSSI (PSSI90) from baseline at week 12. The 100 mg dose of tildrakizumab was compared to placebo for each outcome measure. Both the primary and key secondary efficacy outcomes were analyzed using the intention-to-treat (ITT) population with the Cochran-Mantel-Haenszel test stratified by body weight (≤90 kg or >90 kg) and previous exposure to TNF-alpha inhibitors for psoriasis (yes / no). As an ancillary, all analyses were performed on the per-protocol population. In addition, the Mantel-Haenszel common risk (response rate) difference between the tildrakizumab 100 mg dose group and placebo, and 95% confidence intervals, were estimated. A mixed-model repeated measures (MMRM) treatment approach was also applied to all time-point data up to week 16. [Table 1-1] [Table 1-2] [Table 1-3] [Table 2-1] [Table 2-2]

[0267] Example 2. Results of Administration of Tildrakizumab to Subjects with Plaque Psoriasis of the Scalp. Part 1 The following results were obtained after completion of Part 1 of the 16-week Phase 3 clinical trial protocol described in Example 1. In Part 1, the protocol was double-blind, placebo-controlled, and subjects received either tildrakizumab 100 mg (Arm A, n=117) or placebo (Arm B, n=114) SC at weeks 0 and 4.

[0268] The modified intention-to-treat (mITT) arm includes all subjects who received study drug and were randomized under protocol amendments 01, 02, or 03. The uniform intention-to-treat (uITT) arm includes all subjects who received study drug and were randomized under protocol amendments 02 or 03.

[0269] Table 3 provides an overview of the treatment of subjects in part 1 of the study, including all randomized subjects receiving study drug.

[0270] Tables 4 (mITT) and 5 (uITT) provide an overview of the demographic and baseline characteristics of subjects in the mITT and uITT groups in Part 1 of the study.

[0271] Table 6 shows an overall summary of treatment-emergent adverse events for part 1 of the study.

[0272] Table 7 shows a summary of subjects with treatment-emergent adverse events by organ system class, and Table 8 provides a summary of subjects with treatment-emergent adverse events by organ system class in Part 1 and relationship to study drug.

[0273] Table 9 provides an overview of the magnitude of exposure for Part 1 at baseline (week 0) and week 4.

[0274] Tables 10 (mITT group) and 11 (uITT group) show the analysis of the primary efficacy outcome, IGA Revised 2011 (scalp) response rate at week 16 for part 1. Table 12 shows the analysis of the primary efficacy outcome, IGA Revised 2011 (scalp) response rate at week 16 for part 1 in the Per Protocol (PP) group. The PP group includes all subjects in the mITT population who completed 16 weeks of placebo-controlled treatment without major protocol deviations that could affect data interpretability for the primary efficacy endpoint.

[0275] Tables 13 (ITT group) and 14 (mITT group) show the analysis of the key secondary efficacy outcome, PSSI-90 response rate, at 16 weeks for part 1.

[0276] Tables 15 (ITT group) and 16 (mITT group) show the analysis of the additional secondary efficacy outcome, IGA (scalp) response rate, at 16 weeks for part 1.

[0277] Table 17 (mITT group) shows the analysis of the key secondary efficacy outcome, IGA Revised 2011 (scalp) response rate at 12 weeks for Part 1.

[0278] In summary, Tables 3-17 represent the successful completion of Part 1 of the Phase 3 clinical trial protocol described in Example 1 and show the results of treatment of scalp plaque psoriasis with tildrakizumab over 16 weeks. Subjects treated with tildrakizumab showed significant improvement in scalp plaque psoriasis as measured by IGA Revised 2011 (scalp), PSSI-90, and IGA (scalp). Furthermore, treatment was well tolerated, with no subjects experiencing drug-related serious treatment-emergent adverse events (TEAEs).

[0279] Example 3. Results of Administration of Tildrakizumab to Subjects with Scalp Plaque Psoriasis Part 2 A multicenter, randomized, double-blind, placebo-controlled trial (NCT03897088) was conducted in 231 subjects with moderate to severe psoriasis of the scalp who were treated with tildrakizumab 100 mg (n=117) or placebo (n=114) at weeks 0 and 4, and every 12 weeks thereafter. Of the 231 randomized subjects, 217 subjects completed part 1 (days 1-16). Between weeks 16-52, subjects randomized to placebo were switched to tildrakizumab 100 mg at weeks 16, 20, 32, and 44.

[0280] The primary endpoint was the proportion of subjects who achieved a reduction of at least 2 points from baseline in the IGA score for the scalp, i.e., "clear" and "almost clear," at 16 weeks.

[0281] Other outcomes evaluated included a) the proportion of subjects achieving a Psoriasis Scalp Severity Index (PSSI) of 90 (≥90% improvement from baseline in PSSI) at week 16, b) the proportion of subjects achieving a PSSI of 90 at week 12, and c) the IGA for scalp scores achieving "clear" or "almost clear" at week 12, a reduction of at least 2 points from baseline.

[0282] Subjects in the tildrakizumab and placebo arms were primarily male (60.2%) and Caucasian (78.9), with a mean age of 44.8 years. At baseline, these subjects had a median affected scalp surface area (SSA) of 50%, a median PASI score of 16.7, and 87.1% and 12.3% of PGA scores of 3 (moderate) or 4 (severe), respectively.

[0283] Table 18 (mITT group) shows outcomes by IGA Revised 2011 (scalp) response rate by visit over 52 weeks in Part 2.

[0284] Table 19 (ITT group) shows outcomes by PSSI 90 response rate by visit over 52 weeks in Part 2.

[0285] Table 20 shows the percentage of subjects who achieved "clear" and "almost clear" at Week 16, with a reduction of at least 2 points from baseline in Investigator Global Assessment Revised 2011 (scalp) score.

[0286] Table 21 shows the percentage of subjects who achieved at least a 90% improvement from baseline in Psoriasis Scalp Severity Index at Week 16.

[0287] Table 22 shows the mean percent change in Psoriasis Scalp Severity Index scores from baseline to Week 16.

[0288] Table 23 shows the percentage of subjects who achieved a Psoriasis Scalp Severity Index of 75 at Week 16.

[0289] Table 24 shows the percentage of subjects who achieved a Psoriasis Scalp Severity Index of 100 at Week 16.

[0290] Table 25 shows the mean percent change in scalp surface area (SSA) involvement from baseline to week 16.

[0291] Table 26 shows the time to 75% reduction in Psoriasis Scalp Severity Index during the 16-week placebo-controlled treatment period.

[0292] Table 27 shows the time to response on Investigator Global Assessment Revised 2011 (scalp) during the 16-week placebo-controlled treatment period.

[0293] Table 28 shows the percentage of subjects who achieved a 4-point reduction in Itch Numeric Rating Scale score from baseline to Week 16.

[0294] Table 29 shows the percentage of subjects who achieved a Psoriasis Area Severity Index (PASI) of 75, a Psoriasis Area Severity Index of 90, and a Psoriasis Area Severity Index of 100 at Week 16.

[0295] Table 30 shows the percentage of subjects achieving a Physician's Global Assessment Score (global) score of "clear" or "almost clear" with at least a 2-point reduction from baseline to Week 16.

[0296] Table 31 shows the mean percent change in total body surface area (BSA) involvement from baseline to week 16.

[0297] Table 32 shows the percentage of subjects who achieved "clear" and "almost clear" with a reduction of at least 2 points from baseline in Investigator's Global Assessment (scalp only) score at Week 16.

[0298] Table 33 shows the percentage of subjects who achieved "clear" and "almost clear" at Week 16, with a reduction of at least 2 points from baseline in the Investigator's Global Assessment Revised 2011 score (global).

[0299] Table 34 shows the percentage of subjects who achieved "clear" and "almost clear" IGA Revised 2011 (scalp) scores that were reduced by at least 2 points from baseline.

[0300] Table 35 shows the percentage of subjects who achieved at least a 90% improvement from baseline in Psoriasis Scalp Severity Index at Week 12.

[0301] Table 36 shows the change from baseline in Investigator Global Assessment Revised 2011 (scalp) at Week 52.

[0302] Table 37 shows the change from baseline in IGA Revised 2011 (whole body) at Week 52.

[0303] Table 38 shows the mean change from baseline in Psoriasis Scalp Severity Index scores at Week 52.

[0304] Table 39 shows the change from baseline in Investigator's Global Assessment (scalp only) at Week 52.

[0305] Table 40 shows the change from baseline in scalp itch Numeric Rating Scale (NRS) scores at Week 52.

[0306] Table 41 shows the mean change from baseline in PASI scores at Week 52.

[0307] Table 42 shows the change from baseline in Physician's Global Assessment of Skin (Total) at Week 52.

[0308] Table 43 shows the change from baseline in Dermatology-Related Life Quality Index scores (total and six domain scores) at measured time points through Week 52.

[0309] Table 44 provides an overview of adverse events reported through Week 72. [Table 3] [Table 4-1] [Table 4-2] [Table 4-3]

Table 4-4

Table 5-1

Table 5-2

Table 5-3

Table 5-4

Table 6

Table 7-1

Table 7-2

Table 7-3

Table 8-1

Table 8-2

Table 8-3

Table 8-4

Table 8-5

Table 8-6

Table 9

Table 10

Table 11

Table 12

Table 13

Table 14

Table 15

Table 16

Table 17

Table 18-1

Table 18-2

Table 19-1

Table 19-2

Table 20

Table 21

Table 22

Table 23

Table 24

Table 25

Table 26

Table 27

Table 28

Table 29

Table 30

Table 31

Table 32

Table 33

Table 34

Table 35

Table 36

Table 37

Table 38

Table 39

Table 40

Table 41

Table 42

Table 43

Table 44-1

Table 44-2

Claims

1. 1. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, A first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter.

2. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition of the first dose, the pharmaceutical composition of the second dose, and the pharmaceutical composition of the subsequent doses are the same.

3. 3. The pharmaceutical composition of claim 2, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent doses of the pharmaceutical composition contain 100 mg of hum13B8-b.

4. 10. The method of claim 1, wherein said subsequent doses of said pharmaceutical composition are administered every 12 weeks for up to at least 16 weeks.

5. 10. The method of claim 1, wherein said subsequent doses of said pharmaceutical composition are administered every 4 weeks for up to at least 28 weeks.

6. 10. The method of claim 1, wherein the subsequent doses of the pharmaceutical composition are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

7. 1. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, A pharmaceutical composition, wherein administration of the pharmaceutical composition results in a reduction of at least 2 points from the patient's baseline score on the Investigator Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear."

8. 8. The pharmaceutical composition of claim 7, wherein administration of the pharmaceutical composition results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Numeric Rating Scale for Itch Scalp (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

9. 1. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, The pharmaceutical composition, wherein administration of the pharmaceutical composition results in a significant improvement in the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score from the patient's baseline score.

10. 10. The pharmaceutical composition of claim 9, wherein administration of the pharmaceutical composition results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

11. 1. A pharmaceutical composition of anti-IL-23p19 antibody hum13B8-b for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, a first dose of the pharmaceutical composition is administered subcutaneously to the patient at week 0, a second dose of the pharmaceutical composition is administered subcutaneously to the patient at week 4, and subsequent doses of the pharmaceutical composition are administered subcutaneously to the patient every 4 to 12 weeks thereafter; A pharmaceutical composition, wherein administration of the pharmaceutical composition results in a reduction of at least 2 points from the patient's baseline score on the Investigator Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear."

12. 12. The pharmaceutical composition of claim 11, wherein administration of the pharmaceutical composition results in a further significant improvement in the Psoriasis Scalp Severity Index (PSSI) from the patient's baseline score.

13. 13. The pharmaceutical composition of claim 11 or 12, wherein the pharmaceutical composition of the first dose, the pharmaceutical composition of the second dose, and the pharmaceutical composition of the subsequent dose are the same.

14. 14. The pharmaceutical composition of claim 13, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and the subsequent doses of the pharmaceutical composition contain 100 mg of hum13B8-b.

15. 1. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, wherein said first dose of drug is administered subcutaneously to said patient at week 0, said second dose of drug is administered subcutaneously to said patient at week 4, and said subsequent doses of drug are administered subcutaneously to said patient every 4 to 12 weeks thereafter.

16. 16. The use of claim 15, wherein the first dose of the drug, the second dose of the drug, and the subsequent doses of the drug are the same.

17. 17. The use of claim 16, wherein the first dose of the drug, the second dose of the drug, and the subsequent doses of the drug contain 100 mg of hum13B8-b.

18. 16. The use of claim 15, wherein the treatment comprises administering the subsequent doses every 16 weeks for up to at least 12 weeks.

19. 16. The use of claim 15, wherein the treatment comprises administering the subsequent doses every 4 weeks for up to at least 28 weeks.

20. 16. The use of claim 15, wherein the subsequent doses of the medicament are administered every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

21. 1. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, Use in which administration of the agent achieves a "clear" or "almost clear" Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) score of at least 2 points from the patient's baseline score.

22. 22. The use of claim 21, wherein administration of the agent results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

23. 1. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, The use, wherein administration of the agent results in a significant improvement from the patient's baseline score on the Investigator's Global Assessment (IGA) Revised 2011 Rating Scale (Scalp) score.

24. 24. The use of claim 23, wherein administration of the agent results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Scalp Itch Numeric Rating Scale (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

25. 1. Use of the anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for the treatment of psoriasis vulgaris of the scalp of a patient, comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, at week 0, said first dose of drug is administered subcutaneously to said patient, at week 4, said second dose of drug is administered subcutaneously to said patient, and thereafter every 4 to 12 weeks, said subsequent doses of drug are administered subcutaneously to said patient; The administration of the agent results in a reduction of at least 2 points from the patient's baseline score on the Investigator Global Assessment (IGA) Revised 2011 scale (scalp) score of "clear" or "almost clear."

26. 26. The use of claim 25, wherein administration of the agent results in a further significant improvement in the Psoriasis Scalp Severity Index (PSSI) from the patient's baseline score.

27. 27. The use of claim 25 or 26, wherein the first dose of drug, the second dose of drug, and the subsequent doses of drug are the same.

28. 28. The use of claim 27, wherein the first dose of the drug, the second dose of the drug, and the subsequent doses of the drug contain 100 mg of hum13B8-b.

29. 1. A method for the treatment of psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein at week 0 a first dose of hum13B8-b is administered subcutaneously to the patient, at week 4 a second dose of hum13B8-b is administered subcutaneously to the patient, and every 4 to 12 weeks thereafter subsequent doses of hum13B8-b are administered subcutaneously to the patient; hum13B8-b, (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:

2.

30. 30. The method of claim 29, wherein the first dose, the second dose, and the subsequent dose are the same.

31. 31. The method of claim 30, wherein the first dose, the second dose, and the subsequent doses are 100 mg.

32. 30. The method of claim 29, wherein the treatment comprises administering the subsequent dose every 12 weeks for up to at least 16 weeks.

33. 30. The method of claim 29, wherein said treatment comprises administering said subsequent doses every 4 weeks for up to at least 28 weeks.

34. 30. The method of claim 29, wherein the subsequent doses are administered to the patient every 12 weeks for at least 40 weeks, at least 52 weeks, at least 72 weeks, or more.

35. 1. A method for the treatment of psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b achieves a "clear" or "almost clear" Investigator Global Assessment (IGA) Revised 2011 scale (scalp) score of at least 2 points from the patient's baseline score; hum13B8-b, (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:

2.

36. 36. The method of claim 35, wherein administration of hum13B8-b results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Numeric Rating Scale for Itch Scalp (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

37. 1. A method for the treatment of psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein administration of hum13B8-b results in a significant improvement from the patient's baseline score on the Investigator's Global Assessment (IGA) Revised 2011 scale (scalp) score; hum13B8-b, (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:

2.

38. 38. The method of claim 37, wherein administration of humB13B-b results in a significant improvement from the patient's baseline scores in at least two of four parameters selected from the group consisting of: (i) Investigator's Global Assessment (Scalp Only) (IGA) score, (ii) Numeric Rating Scale for Itch Scalp (NRS) score, (iii) Scalp Surface Area (SSA) score, and (iv) Psoriasis Scalp Severity Index (PSSI) score.

39. 1. A method for determining the efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, and, The method demonstrates efficacy of the anti-IL-23p19 antibody by achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) score of at least 2 points from the patient's baseline score at Week 12, or Week 16, or Week 52.

40. 40. The method of claim 39, further demonstrating efficacy of the anti-IL-23p19 antibody by improving the Psoriasis Scalp Severity Index (PSSI) by at least 90% from the patient's baseline score at week 12, or week 16, or week 52.

41. 1. A method for the treatment of psoriasis vulgaris of the scalp, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein at week 0 a first dose of hum13B8-b is administered subcutaneously to the patient, at week 4 a second dose of hum13B8-b is administered subcutaneously to the patient, and every 4 to 12 weeks thereafter subsequent doses of hum13B8-b are administered subcutaneously to the patient; hum13B8-b, (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, A method in which administration of hum13B8-b results in the Investigator Global Assessment (IGA) Revised 2011 scale (scalp) score being reduced by at least 2 points from the patient's baseline score to "clear" or "almost clear."

42. 42. The method of claim 41, wherein administration of hum13B8-b results in a further significant improvement in the Psoriasis Scalp Severity Index (PSSI) from the patient's baseline score.

43. 43. The method of claim 41 or 42, wherein the initial dose and the subsequent dose are the same.

44. 44. The method of claim 43, wherein the initial dose and the subsequent doses are 100 mg.

45. 1. A method for determining the efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2; A method showing efficacy of the anti-IL-23p19 antibody by achieving a "clear" or "almost clear" Investigator Global Assessment (IGA) Revised 2011 Scale (Scalp) score of at least 2 points from the patient's baseline score at Week 52.

46. 46. ​​The method of claim 45, wherein the Psoriasis Scalp Severity Index (PSSI) at week 52 provides a significant improvement from the patient's baseline score, further demonstrating efficacy of the anti-IL-23p19 antibody.

47. The method of claim 45, further demonstrating efficacy of the anti-IL-23p19 antibody by improving the Psoriasis Scalp Severity Index (PSSI) by at least 75% from the patient's baseline score at week 52.

48. 1. A method for determining the efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, The method, wherein efficacy of the anti-IL-23p19 antibody is demonstrated by a 4 point reduction in the patient's itch scalp NRS score from their baseline score at week 16.

49. 1. A method for determining the efficacy of an anti-IL-23p19 antibody for the treatment of scalp psoriasis vulgaris, comprising administering a therapeutically effective amount of the anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is administered subcutaneously to the patient at week 0, a second dose of hum13B8-b is administered subcutaneously to the patient at week 4, and subsequent doses of hum13B8-b are administered subcutaneously to the patient every 4 to 12 weeks thereafter, wherein hum13B8-b (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:1; (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:2, The efficacy of the anti-IL-23p19 antibody is demonstrated by achieving a PGA-S score (global) reduction of at least 2 points from the patient's baseline score to "clear" or "near clear" at week 16.

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