Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials

• DOI: 10.1007/s13555-020-00367-x
• Publication Date: 2020-03-21T08:02:55Z
• Authors: Craig Leonardi; Kristian Reich; Peter Foley; Hideshi Torii; Sascha Gerdes; Lyn Guenther; Melinda Gooderham; Laura K. Ferris; Christopher E. M....; Hany ElMaraghy; Heidi Crane; Himanshu Patel; Russel Burge; Gaia Gallo; David Shrom; Ann Leung; Chen-Yen Lin; Kim Papp
• Keywords: Ixekizumab; Imputation (statistics); Tolerability

Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety ixekizumab in psoriasis through 5 years. Data were integrated from UNCOVER-1 UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received labeled dose, static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 completed 60 weeks could enter extension (LTE) period. escalate every-2-week dosing per investigator opinion. Efficacy health outcomes included proportion patients achieving Psoriasis Area Severity Index (PASI) 75/90/100, sPGA (0), absolute PASI ≤ 5/ 3/ 2/ 1 Dermatology Life Quality (DLQI) (0,1). Results exclude escalated dosing. A modified non-responder imputation method used account missing data. Supplemental analyses include observed multiple results. Exposure-adjusted are also reported. Of 206 entered LTE periods, 172 treatment. At 60, 75/90/100 responses 94.7%, 85.0% 62.1%, respectively, year 90.3%, 71.3% 46.3%, respectively. Similarly, meaningful achieved other measures. Among with 100 years, 92% DLQI (0,1), indicating no impact skin disease on quality life. During period, exposure-adjusted incidence rates 31.4 patient-years treatment-emergent adverse events 6.8 serious events. No deaths new or unexpected findings noted. The results demonstrate 80 mg maintains profile consistent previous data years ClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.