医学
安慰剂
银屑病
斑块性银屑病
内科学
胃肠病学
皮肤科生活质量指数
银屑病面积及严重程度指数
起效
临床试验
皮肤病科
病理
替代医学
作者
J. Zhang,Y. Ding,P. Wang,L. Li,W. Pan,Y. Lu,L. Liu,R.M. Kisa,K. Hoyt,S. Banerjee
标识
DOI:10.1016/j.jid.2023.03.644
摘要
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, Japan, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis. Deucravacitinib was well tolerated and efficacious in two global phase 3 trials, POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751), as well as in POETYK PSO-3 (NCT04167462), a phase 3 trial in patients from mainland China, Taiwan, and South Korea. Here, we report onset of action and maintenance of response to deucravacitinib in PSO-3. Deucravacitinib (n=146) was associated with significantly larger mean changes from baseline vs placebo (n=74) by Week 1 in Psoriasis Area and Severity Index (PASI) and the more convenient measure in clinic, body surface area by static Physician’s Global Assessment (BSA×sPGA) (−2.8,P<0.002 and −10.1, P<0.04, respectively) and by Week 2 in BSA involvement (−3.3, P<0.0007). Achievement of PASI 75 and sPGA score of 0 (clear) or 1 (almost clear) was significantly higher with deucravacitinib vs placebo by Week 4 (P<0.006 and P<0.0006, respectively). Responses were maintained through 52 weeks with continuous deucravacitinib treatment; patients who crossed over from placebo at Week 16 had comparable results at Week 52. Patient-reported outcomes (PSSD, DLQI 0/1) were improved as early as Week 2 with deucravacitinib vs placebo; improvements were maintained through Week 52. Deucravacitinib displayed a rapid onset of action by Week 1 and sustained maintenance of response in Asian patients with moderate to severe plaque psoriasis.
科研通智能强力驱动
Strongly Powered by AbleSci AI