{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:17:38Z","timestamp":1791573458086,"version":"4.3.4"},"reference-count":48,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,3,22]],"date-time":"2019-03-22T00:00:00Z","timestamp":1553212800000},"content-version":"vor","delay-in-days":0,"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>We report tofacitinib efficacy and safety in Asia\u2010Pacific patients who participated in the rheumatoid arthritis (RA) clinical development program.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>This post\u2010hoc analysis included pooled data from patients with RA in the Asia\u2010Pacific region treated with tofacitinib with\/without conventional synthetic disease\u2010modifying antirheumatic drugs in Phase (P)1, 2, 3, and long\u2010term extension (LTE) studies (one LTE ongoing; January 2016 data\u2010cut). Efficacy was assessed over 24\u00a0months in patients who received tofacitinib 5 (N\u00a0=\u00a0397) or 10 (N\u00a0=\u00a0382) mg twice daily or placebo (N\u00a0=\u00a0243) in three P2 and five P3 studies. Endpoints included American College of Rheumatology (ACR)20\/50\/70 responses, Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28\u20104[ESR]) and Clinical Disease Activity Index (CDAI) remission rates, and change from baseline in Health Assessment Questionnaire\u2010Disability Index (\u2206HAQ\u2010DI). Safety data pooled over 92\u00a0months from one P1, four P2, six P3, and two LTE studies for all tofacitinib doses (N\u00a0=\u00a01464) included incidence rates (IRs) (patients with events\/100 patient\u2010years) for adverse events (AEs) of special interest.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At month 3, patients receiving tofacitinib 5\/10\u00a0mg twice daily improved vs placebo in ACR20 (69.2%\/77.9% vs 27.5%), ACR50 (36.9%\/44.4% vs 9.5%), and ACR70 (15.1%\/22.4% vs 2.7%) responses, remission rates for DAS28\u20104(ESR) (8.5%\/18.5% vs 2.6%) and CDAI (6.1%\/12.3% vs 0.5%), and \u2206HAQ\u2010DI (\u22120.5\/\u20130.6 vs \u22120.1); improvements were sustained through 24\u00a0months. IRs (95%\u00a0CI) were 9.4 (8.5, 10.3) for serious AEs, 9.1 (8.3, 10.1) for discontinuations due to AEs, 3.7 (3.2, 4.3) for serious infections, 5.9 (5.2, 6.7) for herpes zoster, and 0.8 (0.6, 1.1) for malignancies (excluding non\u2010melanoma skin cancer).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In Asia\u2010Pacific patients, tofacitinib improved signs\/symptoms over 24\u00a0months. Safety over 92\u00a0months was generally consistent with global tofacitinib studies; however, infection IRs were higher in Asia\u2010Pacific patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.13516","type":"journal-article","created":{"date-parts":[[2019,3,22]],"date-time":"2019-03-22T08:49:57Z","timestamp":1553244597000},"page":"1094-1106","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia\u2010Pacific region: Post\u2010hoc analyses of pooled clinical study data"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0703-1208","authenticated-orcid":false,"given":"Eun Bong","family":"Lee","sequence":"first","affiliation":[{"name":"Seoul National University College of Medicine Seoul 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