Andrew Blauvelt1, Melinda Gooderham2, Lars Iversen3, Susan Ball4, Lu Zhang4, Noah O Agada4, Kristian Reich5. 1. Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com. 2. Queen's University, SKiN Centre for Dermatology, Peterborough, Canada. 3. Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. 4. Eli Lilly and Company, Indianapolis, Indiana. 5. Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany.
Abstract
BACKGROUND:Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, is efficacious in treating moderate-to-severe plaque psoriasis through 60 weeks. OBJECTIVE: To evaluate the efficacy and safety of ixekizumab through 108 weeks of treatment in UNCOVER-3. METHODS:Patients (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. RESULTS: For 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. LIMITATIONS: There was no comparison treatment group after week 12. CONCLUSION:Ixekizumab is well tolerated and demonstrates persistent efficacy through 108 weeks.
RCT Entities:
BACKGROUND:Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, is efficacious in treating moderate-to-severe plaque psoriasis through 60 weeks. OBJECTIVE: To evaluate the efficacy and safety of ixekizumab through 108 weeks of treatment in UNCOVER-3. METHODS:Patients (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. RESULTS: For 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. LIMITATIONS: There was no comparison treatment group after week 12. CONCLUSION:Ixekizumab is well tolerated and demonstrates persistent efficacy through 108 weeks.
Authors: Johan Burisch; Wolfgang Eigner; Stefan Schreiber; Daniel Aletaha; Wolfgang Weninger; Michael Trauner; Walter Reinisch; Neeraj Narula Journal: PLoS One Date: 2020-05-27 Impact factor: 3.240
Authors: R Bissonnette; T Luger; D Thaçi; D Toth; A Lacombe; S Xia; R Mazur; M Patekar; P Charef; M Milutinovic; C Leonardi; U Mrowietz Journal: J Eur Acad Dermatol Venereol Date: 2018-03-22 Impact factor: 6.166