Ixekizumab treatment for psoriasis: integrated efficacy analysis of three double-blinded, controlled studies (UNCOVER-1, UNCOVER-2, UNCOVER-3)

伊克泽珠单抗 依那西普 医学 银屑病 安慰剂 银屑病面积及严重程度指数 内科学 析因分析 加药 皮肤病科 药理学 塞库金单抗 肿瘤坏死因子α 银屑病性关节炎 病理 替代医学
作者
Kim Papp,Craig L. Leonardi,Andrew Blauvelt,Kristian Reich,Neil J. Korman,Mamitaro Ohtsuki,C. Paul,Susan Ball,Greg Cameron,Janelle Erickson,L. Zhang,Lotus Mallbris,Cem Griffiths
出处
期刊:British Journal of Dermatology [Oxford University Press]
卷期号:178 (3): 674-681 被引量:77
标识
DOI:10.1111/bjd.16050
摘要

Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for the treatment of moderate-to-severe psoriasis.This analysis represents an overview of the efficacy outcomes from three phase III psoriasis studies.Data were integrated from the 12-week induction period of three studies in which patients received ixekizumab 80 mg every 2 weeks (IXE Q2W; n = 1169) or every 4 weeks (IXE Q4W; n = 1165) after an initial 160-mg dose for both; etanercept (50 mg biweekly; n = 740; two studies) or placebo (n = 792). The coprimary end points were the percentages of patients with response of static Physician's Global Assessment (sPGA; score 0 or 1) and ≥ 75% improvement in baseline Psoriasis Area and Severity Index (PASI 75) at week 12. Response rates were compared between treatments using the Cochran-Mantel-Haenszel test stratified by study. Treatment comparisons with placebo included data from three studies, whereas etanercept comparisons were based on two studies.Ixekizumab treatment was superior to placebo (P < 0·001) and etanercept (P < 0·001) on sPGA (0, 1) and PASI 75, with significant differences in PASI improvement at week 1. With IXE Q2W, at week 12, the frequencies of patients achieving PASI 75, 90 and 100 were nearly 90%, 70% and 40%, respectively. Ixekizumab-treated patients showed significantly greater improvement vs. placebo and etanercept in percentage body surface area involvement and fingernail psoriasis. IXE Q2W was superior to IXE Q4W on all treatment outcomes.Ixekizumab therapy at both dosing regimens demonstrated rapid onset and superior efficacy to placebo and etanercept, with IXE Q2W providing better outcomes than IXE Q4W during the first 12 weeks of treatment.

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