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)
| Autor: | Shinichi Imafuku, Fangyi Zhao, Atsushi Nishikawa, Hitoe Torisu-Itakura, Gregory S Cameron |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty interleukin‐17A Concise Communications Phases of clinical research Subgroup analysis Dermatology Antibodies Monoclonal Humanized Placebo law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine ixekizumab Japan Randomized controlled trial Psoriasis Area and Severity Index law Psoriasis Internal medicine Humans Medicine Adverse effect Aged business.industry Concise Communication psoriasis General Medicine Middle Aged medicine.disease Surgery Ixekizumab Treatment Outcome 030220 oncology & carcinogenesis randomized controlled trial Female Dermatologic Agents business |
| Zdroj: | The Journal of Dermatology |
| ISSN: | 0385-2407 |
| Popis: | 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 (IXEQ4W, n = 12) or 2 (IXEQ2W, 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 (IXEQ12W, n = 5) or 4 (IXEQ4W, 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% (IXEQ4W), 40.0% (IXEQ12W) and 16.7% (placebo) had maintained sPGA (0,1). From week 0–12, treatment‐emergent adverse events were 76.9% (placebo), 75.0% (IXEQ4W) and 87.5% (IXEQ2W), and from week 12–60 were 66.7% (placebo) and 100% (IXEQ12W, IXEQ4W). Ixekizumab‐treated patients had no severe treatment‐emergent adverse events, and one serious TEAE (IXEQ4W); 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. |
| Databáze: | OpenAIRE |
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