The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: a Phase 3, randomized, double-blind, placebo-controlled study

Publication date: Available online 16 May 2017
Source:Journal of Dermatological Science
Author(s): JianZhong Zhang, Tsen-Fang Tsai, Min-Geol Lee, Min Zheng, Gang Wang, HongZhong Jin, Jun Gu, RuoYu Li, QuanZhong Liu, Jin Chen, CaiXia Tu, ChunMei Qi, Hua Zhu, William C. Ports, Tim Crook
BackgroundTofacitinib is an oral Janus kinase inhibitor.ObjectiveThis study assessed tofacitinib efficacy and safety vs placebo in Asian patients with moderate to severe chronic plaque psoriasis.MethodsPatients from China mainland, Taiwan, and Korea were randomized 2:2:1:1 to tofacitinib 5mg (N=88), tofacitinib 10mg (N=90), placebo→5mg (N=44), or placebo→10mg (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.ResultsAt Week 16, more patients achieved PGA and PASI75 response with tofacitinib 5mg (52.3%; 54.6%) and 10mg (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 5mg and 10mg 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.ConclusionTofacitinib 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. [NCT01815424]



http://ift.tt/2pXhApc