期刊
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
卷 77, 期 5, 页码 855-862出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2017.06.153
关键词
efficacy; interleukin 17; ixekizumab; long-term; psoriasis; safety; UNCOVER-3
类别
资金
- Eli Lilly and Company
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.
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