{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:18:44Z","timestamp":1792718324938,"version":"4.5.0"},"reference-count":37,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T00:00:00Z","timestamp":1675123200000},"content-version":"unspecified","delay-in-days":30,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2022,10,17]]},"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, were evaluated in a 6-month, double-blind, phase 3 study in Chinese patients with active (polyarthritic) psoriatic arthritis (PsA) and inadequate response to \u22651 conventional synthetic disease-modifying antirheumatic drug.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients were randomised (2:1) to tofacitinib 5 mg twice daily (N=136) or placebo (N=68); switched to tofacitinib 5 mg twice daily after month (M)3 (blinded). Primary endpoint: American College of Rheumatology (ACR50) response at M3. Secondary endpoints (through M6) included: ACR20\/50\/70 response; change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI); \u226575% improvement in Psoriasis Area and Severity Index (PASI75) response, and enthesitis and dactylitis resolution. Safety was assessed throughout.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The primary endpoint was met (tofacitinib 5 mg twice daily, 38.2%; placebo, 5.9%; p&lt;0.0001). M3 ACR20\/ACR70\/PASI75 responses, and enthesitis and dactylitis resolution rates, were higher and HAQ-DI reduction was greater for tofacitinib 5 mg twice daily versus placebo. Incidence of adverse events (AEs)\/serious AEs (M0\u20133): 68.4%\/0%, tofacitinib 5 mg twice daily; 75.0%\/4.4%, placebo. One death was reported with placebo\u2192tofacitinib 5 mg twice daily (due to accident). One serious infection, non-serious herpes zoster, and lung cancer case each were reported with tofacitinib 5 mg twice daily; four serious infections and one non-serious herpes zoster case were reported with placebo\u2192tofacitinib 5 mg twice daily (M0\u20136). No non-melanoma skin cancer, major adverse cardiovascular or thromboembolism events were reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In Chinese patients with PsA, tofacitinib efficacy was greater than placebo (primary and secondary endpoints). Tofacitinib was well tolerated; safety outcomes were consistent with the established safety profile in PsA and other indications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT03486457\">NCT03486457<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2022-002559","type":"journal-article","created":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T10:02:53Z","timestamp":1675159373000},"page":"e002559","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03486457","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct01877668","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01882439","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01976364","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03486457","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Xiaomei","family":"Leng","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, 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