Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial

Abstract

To report the efficacy and safety of the approved ixekizumab (IXE) dose over 5years from UNCOVER-3 (NCT01646177). Patients (N= 1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50mg twice weekly, or IXE 80mg every 2weeks or every 4weeks after an initial dose of IXE 160mg, respectively. At week 12, patients entered the long-term extension period with dosing of IXE every 4weeks and could escalate to every 2weeks after week 60. Efficacy was reported for the IXE every 2weeks/every 4weeks group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXE every 2 or every 4weeks. Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE every 2weeks/every 4weeks (n=385) achieved ≥75%, ≥90%, or 100% improvement from baseline in the Psoriasis Area and Severity Index, respectively, at week 264; static Physician's Global Assessment score of 0/1 and 0 responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients). Lack of comparison treatment group after week 12. IXE demonstrates sustained efficacy and consistent safety through 264weeks in patients using the approved dose.