Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3)

Abstract

Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, is efficacious in treating moderate-to-severe plaque psoriasis through 60weeks. To evaluate the efficacy and safety of ixekizumab through 108weeks of treatment in UNCOVER-3. Patients (N=1346) were randomized 2:2:2:1 to 80mg ixekizumab every 2 or 4weeks, 50mg etanercept twice weekly, or placebo. At week 12, patients switched to ixekizumab every 4weeks during a long-term extension (LTE) period. Efficacy data were summarized using as-observed, multiple imputation (MI), and modified MI (mMI) methods. For patients (N=385) receiving the recommended dose (ixekizumab every 2weeks on weeks 0-12 and every 4weeks during LTE), the 108-week as-observed, MI, and mMI response rates were 93.4%, 88.3%, and 83.6%, respectively, for patients achieving ≥75% improvement from baseline in the Psoriasis Area and Severity Index, and the 108-week as-observed, MI, and mMI response rates were 82.6%, 78.3%, and 74.1%, respectively, for patients with a static Physician's Global Assessment score of 0 or 1. During LTE, 1077 (84.5%) patients reported ≥1 treatment-emergent adverse event, and 85% were mild or moderate in severity. Discontinuation because of adverse events occurred in 6.4% of patients. There was no comparison treatment group after week 12. Ixekizumab is well tolerated and demonstrates persistent efficacy through 108weeks.