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Efficacy and safety of ixekizumab treatment in Japanese patients with moderate‐to‐severe plaque psoriasis: Subgroup analysis of a placebo‐controlled, phase 3 study (UNCOVER‐1)
Author(s) -
Imafuku Shinichi,
TorisuItakura Hitoe,
Nishikawa Atsushi,
Zhao Fangyi,
Cameron Gregory S.
Publication year - 2017
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.13927
Subject(s) - ixekizumab , placebo , medicine , psoriasis , adverse effect , subgroup analysis , psoriasis area and severity index , post hoc analysis , randomized controlled trial , gastroenterology , dermatology , confidence interval , secukinumab , psoriatic arthritis , pathology , alternative medicine
The present study describes a subgroup analysis of 33 Japanese patients participating in UNCOVER ‐1, an international, placebo‐controlled, phase 3 study of ixekizumab in patients with moderate‐to‐severe psoriasis. Patients were randomized to a placebo ( n = 13) or ixekizumab 80 mg every 4 ( IXEQ 4W, n = 12) or 2 ( IXEQ 2W, n = 8) weeks, from week 0–12. At week 12, ixekizumab‐treated patients with a static Physician Global Assessment score 0 or 1 ( sPGA [0,1]; n = 16) were re‐randomized to a placebo ( n = 6), ixekizumab 80 mg every 12 ( IXEQ 12W, n = 5) or 4 ( IXEQ 4W, n = 5) weeks, from week 12–60. At week 12, more ixekizumab‐treated versus placebo‐treated patients achieved sPGA (0,1) (≥66.7% vs 0%), ≥75% improvement in Psoriasis Area and Severity Index (≥75% vs 0%), and sPGA (0) or 100% improvement in Psoriasis Area and Severity Index (both ≥33.3% vs 0%), with improved symptoms and quality of life. At week 60, 100% ( IXEQ 4W), 40.0% ( IXEQ 12W) and 16.7% (placebo) had maintained sPGA (0,1). From week 0–12, treatment‐emergent adverse events were 76.9% (placebo), 75.0% ( IXEQ 4W) and 87.5% ( IXEQ 2W), and from week 12–60 were 66.7% (placebo) and 100% ( IXEQ 12W, IXEQ 4W). Ixekizumab‐treated patients had no severe treatment‐emergent adverse events, and one serious TEAE ( IXEQ 4W); infection was the most frequent treatment‐emergent adverse event. In conclusion, ixekizumab for 60 weeks was effective and safe for Japanese patients with moderate‐to‐severe psoriasis, in line with the overall findings from UNCOVER‐1.