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)

Abstract

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.

Keywords: Japan; interleukin-17A; ixekizumab; psoriasis; randomized controlled trial.