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
Journal
Journal of Dermatological Science
Journal Volume
88
Journal Issue
1
Pages
36-45
Date Issued
2017
Author(s)
Zhang J.
Lee M.-G.
Zheng M.
Wang G.
Jin H.
Gu J.
Li R.
Liu Q.
Chen J.
Tu C.
Qi C.
Zhu H.
Ports W.C.
Crook T.
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 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. [NCT01815424] ? 2017 The Authors and Pfizer Inc.
SDGs
Other Subjects
adalimumab; alanine aminotransferase; aspartate aminotransferase; Chinese drug; creatine kinase; cyclosporin A; etanercept; etretin; glycoside; hemoglobin; high density lipoprotein cholesterol; infliximab; isotretinoin; low density lipoprotein cholesterol; methotrexate; methylprednisolone; placebo; psoralen; tofacitinib; tripterygium glycoside; unclassified drug; ustekinumab; Janus kinase; piperidine derivative; protein kinase inhibitor; pyrimidine derivative; pyrrole derivative; tofacitinib; adult; Article; China; cholesterol blood level; chronic disease; controlled study; disease severity; double blind procedure; drug efficacy; drug safety; drug withdrawal; East Asian; female; hemoglobin blood level; herpes zoster; human; hyperlipidemia; lung adenocarcinoma; lymphocyte count; major clinical study; male; neutrophil count; opportunistic infection; parallel design; phase 3 clinical trial; phototherapy; Physician Global Assessment score; priority journal; psoriasis; Psoriasis Area and Severity Index; randomized controlled trial; rhinopharyngitis; scoring system; side effect; small cell lung cancer; South Korea; Taiwan; treatment duration; treatment response; ultraviolet A radiation; upper respiratory tract infection; urinary tract infection; antagonists and inhibitors; Asian continental ancestry group; clinical trial; middle aged; multicenter study; oral drug administration; psoriasis; severity of illness index; treatment outcome; Administration, Oral; Adult; Asian Continental Ancestry Group; China; Double-Blind Method; Female; Humans; Janus Kinases; Male; Middle Aged; Piperidines; Protein Kinase Inhibitors; Psoriasis; Pyrimidines; Pyrroles; Republic of Korea; Severity of Illness Index; Taiwan; Treatment Outcome
Publisher
Elsevier Ireland Ltd
Type
journal article