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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
DC Field | Value | Language |
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dc.contributor.author | 이민걸 | - |
dc.date.accessioned | 2018-07-20T08:12:34Z | - |
dc.date.available | 2018-07-20T08:12:34Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0923-1811 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/160967 | - |
dc.description.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]. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF DERMATOLOGICAL SCIENCE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Administration, Oral | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | China | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Janus Kinases/antagonists & inhibitors | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Piperidines/therapeutic use* | - |
dc.subject.MESH | Protein Kinase Inhibitors/therapeutic use* | - |
dc.subject.MESH | Psoriasis/drug therapy* | - |
dc.subject.MESH | Pyrimidines/therapeutic use* | - |
dc.subject.MESH | Pyrroles/therapeutic use* | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Severity of Illness Index | - |
dc.subject.MESH | Taiwan | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | 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.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Dermatology | - |
dc.contributor.googleauthor | JianZhong Zhang | - |
dc.contributor.googleauthor | Tsen-Fang Tsai | - |
dc.contributor.googleauthor | Min-Geol Lee | - |
dc.contributor.googleauthor | Min Zheng | - |
dc.contributor.googleauthor | Gang Wang | - |
dc.contributor.googleauthor | HongZhong Jin | - |
dc.contributor.googleauthor | Jun Gu | - |
dc.contributor.googleauthor | RuoYu Li | - |
dc.contributor.googleauthor | QuanZhong Liu | - |
dc.contributor.googleauthor | Jin Chen | - |
dc.contributor.googleauthor | CaiXia Tu | - |
dc.contributor.googleauthor | ChunMei Qi | - |
dc.contributor.googleauthor | Hua Zhu | - |
dc.contributor.googleauthor | William C. Ports | - |
dc.contributor.googleauthor | Tim Crook | - |
dc.identifier.doi | 10.1016/j.jdermsci.2017.05.004 | - |
dc.contributor.localId | A02779 | - |
dc.relation.journalcode | J01370 | - |
dc.identifier.eissn | 1873-569X | - |
dc.identifier.pmid | 28558978 | - |
dc.subject.keyword | Asia | - |
dc.subject.keyword | Efficacy | - |
dc.subject.keyword | Janus kinase inhibitor | - |
dc.subject.keyword | Plaque psoriasis | - |
dc.subject.keyword | Safety | - |
dc.subject.keyword | Tofacitinib | - |
dc.contributor.alternativeName | Lee, Min Geol | - |
dc.contributor.affiliatedAuthor | Lee, Min Geol | - |
dc.citation.volume | 88 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 36 | - |
dc.citation.endPage | 45 | - |
dc.identifier.bibliographicCitation | JOURNAL OF DERMATOLOGICAL SCIENCE, Vol.88(1) : 36-45, 2017 | - |
dc.identifier.rimsid | 60861 | - |
dc.type.rims | ART | - |
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