66 37

Cited 6 times in

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

DC FieldValueLanguage
dc.contributor.author이민걸-
dc.date.accessioned2018-07-20T08:12:34Z-
dc.date.available2018-07-20T08:12:34Z-
dc.date.issued2017-
dc.identifier.issn0923-1811-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/160967-
dc.description.abstractBACKGROUND: 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].-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfJournal of Dermatological Science-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdministration, Oral-
dc.subject.MESHAdult-
dc.subject.MESHAsian Continental Ancestry Group-
dc.subject.MESHChina-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHJanus Kinases/antagonists & inhibitors-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPiperidines/therapeutic use*-
dc.subject.MESHProtein Kinase Inhibitors/therapeutic use*-
dc.subject.MESHPsoriasis/drug therapy*-
dc.subject.MESHPyrimidines/therapeutic use*-
dc.subject.MESHPyrroles/therapeutic use*-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHSeverity of Illness Index-
dc.subject.MESHTaiwan-
dc.subject.MESHTreatment Outcome-
dc.titleThe efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Dermatology-
dc.contributor.googleauthorJianZhong Zhang-
dc.contributor.googleauthorTsen-Fang Tsai-
dc.contributor.googleauthorMin-Geol Lee-
dc.contributor.googleauthorMin Zheng-
dc.contributor.googleauthorGang Wang-
dc.contributor.googleauthorHongZhong Jin-
dc.contributor.googleauthorJun Gu-
dc.contributor.googleauthorRuoYu Li-
dc.contributor.googleauthorQuanZhong Liu-
dc.contributor.googleauthorJin Chen-
dc.contributor.googleauthorCaiXia Tu-
dc.contributor.googleauthorChunMei Qi-
dc.contributor.googleauthorHua Zhu-
dc.contributor.googleauthorWilliam C. Ports-
dc.contributor.googleauthorTim Crook-
dc.identifier.doi10.1016/j.jdermsci.2017.05.004-
dc.contributor.localIdA02779-
dc.relation.journalcodeJ01370-
dc.identifier.eissn1873-569X-
dc.identifier.pmid28558978-
dc.subject.keywordAsia-
dc.subject.keywordEfficacy-
dc.subject.keywordJanus kinase inhibitor-
dc.subject.keywordPlaque psoriasis-
dc.subject.keywordSafety-
dc.subject.keywordTofacitinib-
dc.contributor.alternativeNameLee, Min Geol-
dc.contributor.affiliatedAuthorLee, Min Geol-
dc.citation.volume88-
dc.citation.number1-
dc.citation.startPage36-
dc.citation.endPage45-
dc.identifier.bibliographicCitationJournal of Dermatological Science, Vol.88(1) : 36-45, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.