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

Abstract Objective To report efficacy and safety of the approved IXE dose over 5 years from UNCOVER-3. (NCT01646177). Methods Patients (N=1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50 mg twice weekly, IXE 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) following an initial dose of IXE 160 mg. At Week 12, patients entered the long-term extension (LTE) period with IXEQ4W dosing and could escalate to Q2W after Week 60. Efficacy was reported for the IXEQ2W/Q4W group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXEQ2W/Q4W. Results Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE Q2W/Q4W (N=385) achieved ≥75%, ≥90%, or 100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 264, respectively; static Physician’s Global Assessment (sPGA) score of (0/1) and sPGA (0) responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients). Limitations Lack of comparison treatment group after Week 12. Conclusion IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose.