Safe and Effective Method of Treating Psoriatic Arthritis with Anti-IL23 Specific Antibody
AssigneeJanssen Biotech, Inc.
InventorsElizabeth Hsia, Xie Xu, Alexa Kollmeier, Bei Zhou
Life of this patent
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Abstract
A method of treating psoriatic arthritis in a patient by administering an IL-23 specific antibody, e.g., guselkumab, in a clinically proven safe and clinically proven effective amount and the patient achieves significant ACR20/50/70, IGA, HAQ-DI, CRP, SF-36 PCS/MCS, MDA, VLDA, enthesitis, dactylitis, and LEI/dactylitis improvement as measured 16 and 24 weeks after initial treatment.
Claims27
A method of treating psoriatic arthritis in a subject in need thereof, comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody once every 4 weeks (q4w), wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:
- 1, a CDRH2 of SEQ ID NO:
- 2, and a CDRH3 of SEQ ID NO:
- 3;
- and the light chain variable region comprising a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:
- 4, a CDRL2 of SEQ ID NO:
- 5, and a CDRL3 of SEQ ID NO:
- 6, and wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20) after the treatment.
A method of treating psoriastic arthritis in a subject in need thereof comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody once at week 0, once at week 4, and once every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:
- 1, a CDRH2 of SEQ ID NO:
- 2, and a CDRH3 of SEQ ID NO:
- 3;
- and the light chain variable region comprising a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:
- 4, a CDRL2 of SEQ ID NO:
- 5, and a CDRL3 of SEQ ID NO:
- 6, and wherein the subject has at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment, and the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20).
A pharmaceutical composition of an anti-IL-23 antibody, comprising:
- a. an antibody comprising:
- (i) a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising:
- a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1;
- a CDRH2 amino acid sequence of SEQ ID NO:2;
- and a CDRH3 amino acid sequence of SEQ ID NO:3;
- and the light chain variable region comprising:
- a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4;
- a CDRL2 amino acid sequence of SEQ ID NO:5;
- and a CDRL3 amino acid sequence of SEQ ID NO:6;
- (ii) a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8;
- or (iii) a heavy chain of the amino acid sequence of SEQ ID NO:9 and a light chain of the amino acid sequence of SEQ ID NO:10;
- and
- b. packaging comprising one or more drug product label elements disclosed in Annex I including data from a randomized, double-blind, placebo-controlled, clinical study in adult men and women with moderately to severely active psoriatic arthritis.
A method of selling a drug product comprising guselkumab, comprising:
- manufacturing guselkumab;
- promoting that a therapy comprising guselkumab is safe and effective for treatment of a subject with psoriatic arthritis, wherein performing the steps a) and b) results in a health care professional (HCP) to purchase the drug product;
- thereby selling the drug product.
Dependencies are inferred from the claim text.