期刊
JOURNAL OF DERMATOLOGICAL SCIENCE
卷 88, 期 1, 页码 36-45出版社
ELSEVIER IRELAND LTD
DOI: 10.1016/j.jdermsci.2017.05.004
关键词
Asia; Janus kinase inhibitor; Tofacitinib; Plaque psoriasis; Efficacy; Safety
类别
资金
- Pfizer Inc.
Background: Tofacitinib is an oral Janus kinase inhibitor. Objective: This study assessed tofacitinib efficacy and safety vs placebo in Asian patients with moderate to severe chronic plaque psoriasis. Methods: Patients from China mainland, Taiwan, and Korea were randomized 2:2:1:1 to tofacitinib 5 mg (N = 88), tofacitinib 10 mg (N = 90), placebo -> 5 mg (N = 44), or placebo -> 10 mg (N = 44), twice daily (BID) for 52 weeks. Placebo-treated patients advanced to tofacitinib at Week 16. Co-primary efficacy endpoints: proportions of patients achieving Physician's Global Assessment (PGA) response ('clear' or 'almost clear') and proportion achieving >= 75% reduction from baseline Psoriasis Area and Severity Index (PASI75) at Week 16. Results: At Week 16, more patients achieved PGA and PASI75 responses with tofacitinib 5 mg (52.3%; 54.6%) and 10 mg (75.6%; 81.1%) BID vs placebo (19.3%; 12.5%; all p < 0.0001). Of patients with a Week 16 response, 73.6% and 75.0% maintained PGA response, and 76.8% and 84.9% maintained PASI75 to Week 52 with tofacitinib 5 mg and 10 mg BID, respectively. Over 52 weeks, 2.2-4.5% of patients across treatment groups experienced serious adverse events, and 1.1-6.8% discontinued due to adverse events. Conclusion: Tofacitinib demonstrated efficacy vs placebo at Week 16 in Asian patients with moderate to severe plaque psoriasis; efficacy was maintained through Week 52. No unexpected safety findings were observed. (C) 2017 The Authors and Pfizer Inc. Published by Elsevier Ireland Ltd. on behalf of Journal of Dermatological Science. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据