最后
医学
安慰剂
银屑病
不利影响
内科学
银屑病面积及严重程度指数
随机对照试验
胃肠病学
皮肤病科
银屑病性关节炎
病理
替代医学
作者
April W. Armstrong,Melinda Gooderham,Richard B. Warren,Kim Papp,Bruce Strober,Diamant Thaçi,Akimichi Morita,Jacek C. Szepietowski,Shinichi Imafuku,Elizabeth Colston,John Throup,Sudeep Kundu,Steven Schoenfeld,Misti Linaberry,Subhashis Banerjee,Andrew Blauvelt
标识
DOI:10.1016/j.jaad.2022.07.002
摘要
Effective, well-tolerated oral psoriasis treatments are needed.To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis.Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16.At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast.One-year duration, limited racial diversity.Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.
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