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J. Am. Acad. Dermatol. · Nov 2017
Randomized Controlled Trial Multicenter StudyEfficacy 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).
- Andrew Blauvelt, Melinda Gooderham, Lars Iversen, Susan Ball, Lu Zhang, Noah O Agada, and Kristian Reich.
- Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.
- J. Am. Acad. Dermatol. 2017 Nov 1; 77 (5): 855-862.
BackgroundIxekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, is efficacious in treating moderate-to-severe plaque psoriasis through 60 weeks.ObjectiveTo evaluate the efficacy and safety of ixekizumab through 108 weeks of treatment in UNCOVER-3.MethodsPatients (N = 1346) were randomized 2:2:2:1 to 80 mg ixekizumab every 2 or 4 weeks, 50 mg etanercept twice weekly, or placebo. At week 12, patients switched to ixekizumab every 4 weeks during a long-term extension (LTE) period. Efficacy data were summarized using as-observed, multiple imputation (MI), and modified MI (mMI) methods.ResultsFor patients (N = 385) receiving the recommended dose (ixekizumab every 2 weeks on weeks 0-12 and every 4 weeks 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.LimitationsThere was no comparison treatment group after week 12.ConclusionIxekizumab is well tolerated and demonstrates persistent efficacy through 108 weeks.Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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