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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

Authors
 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 
Citation
 Journal of Dermatological Science, Vol.88(1) : 36-45, 2017 
Journal Title
 Journal of Dermatological Science 
ISSN
 0923-1811 
Issue Date
2017
MeSH
Administration, Oral ; Adult ; Asian Continental Ancestry Group ; China ; Double-Blind Method ; Female ; Humans ; Janus Kinases/antagonists & inhibitors ; Male ; Middle Aged ; Piperidines/therapeutic use* ; Protein Kinase Inhibitors/therapeutic use* ; Psoriasis/drug therapy* ; Pyrimidines/therapeutic use* ; Pyrroles/therapeutic use* ; Republic of Korea ; Severity of Illness Index ; Taiwan ; Treatment Outcome
Keywords
Asia ; Efficacy ; Janus kinase inhibitor ; Plaque psoriasis ; Safety ; Tofacitinib
Abstract
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 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. RESULTS: At Week 16, more patients achieved PGA and PASI75 responses 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. 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. [NCT01815424].
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/160967
DOI
10.1016/j.jdermsci.2017.05.004
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실)
Yonsei Authors
이민걸(Lee, Min Geol)
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