Key clinical point: Ixekizumab proved effective and safe in a phase 3 randomized trial conducted in 203 6- to 18-year-olds with moderate to severe plaque psoriasis.
Major finding: The week-12 PASI 90 response rate was 78% with ixekizumab, 5% in placebo-treated controls, and 40% with etanercept.
Study details: This was a 12-week, double-blind, placebo-controlled, multicenter, phase 3 trial of 203 pediatric psoriasis patients.
Disclosures: Lilly sponsored the study. The presenter reported serving as a consultant, investigator, and/or speaker for Lilly and more than three dozen other pharmaceutical companies.
Papp KA. EADV Late breaker.
Only two biologic agents that target either TNF or IL-12/IL-23 are approved for pediatric patients with moderate to severe plaque psoriasis. While the current options are effective, another mechanism of action that targets IL-17 would be desirable. The efficacy of Taltz in pediatric psoriasis matches the efficacy in adult patients. ASI 75, PASI 90 and PASI 100 responses with ixekizumab versus placebo were 89% vs. 25%, 78% vs. 5%, and 50% vs. 2%, respectively. In addition, 81% of patients on ixekizumab achieved sPGA of 0 or 1 vs. 11% on placebo; 52% of those in the ixekizumab group achieved sPGA of 0 vs. 2% in the placebo group. The dosage of ixekizumab in the pediatric patients was based on body weight. These results are extremely encouraging and submission of ixekizumab as the first IL-17 inhibitor for pediatric psoriasis is widely anticipated.—Paul S. Yamauchi, MD, PhD; Clinical Assistant Professor of Dermatology David Geffen School of Medicine at UCLA; Harbor-UCLA Medical Center Division of Dermatology; Adjunct Associate Professor John Wayne Cancer Institute.