{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T21:59:39Z","timestamp":1793743179347,"version":"4.6.1"},"reference-count":53,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T00:00:00Z","timestamp":1590969600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy\/safety in Indian vs rest of the world (ROW; excluding India) RA patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Efficacy data were pooled for disease\u2010modified antirheumatic drug\u00a0(DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate\u2010na\u00efve) and ORAL Sequel (long\u2010term extension [LTE] study; data cut\u2010off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3\/6: American College of Rheumatology (ACR)20\/50\/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission\/low disease activity; change from baseline in Health Assessment Questionnaire\u2010Disability Index. Incidence rates (IRs; patients with events\/100 patient\u2010years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One\u2010hundred\u2010and\u2010ninety\u2010seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non\u2010smokers and all were biologic DMARD (bDMARD)\u2010na\u00efve. Month 3 ACR20 rates with tofacitinib 5\u00a0mg twice daily\/10\u00a0mg twice daily\/placebo were 67.4%\/82.1%\/40.9% (India) and 59.0%\/66.1%\/28.2% (ROW), and month 6 rates were 76.2%\/92.1%\/88.9% (India) and 69.0%\/74.2%\/66.5% (ROW). Month 3\/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs\/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR\u00a0=\u00a01.21; 95% CI 0.49, 2.49) vs ROW patients (IR\u00a0=\u00a00.17; 95% CI 0.11, 0.25).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Tofacitinib efficacy\/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD\u2010treated RA patients from high\u2010risk countries (IR\u00a0=\u00a00.00\u20102.56; TB IR &gt;0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.13853","type":"journal-article","created":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T12:24:27Z","timestamp":1591014267000},"page":"882-897","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long\u2010term extension studies over 7\u00a0years"],"prefix":"10.1111","volume":"23","author":[{"given":"Arvind","family":"Chopra","sequence":"first","affiliation":[{"name":"Arthritis Research and Care Foundation Center for Rheumatic Diseases Pune India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vineeta","family":"Shobha","sequence":"additional","affiliation":[{"name":"St. John's Medical College Hospital Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2661-9840","authenticated-orcid":false,"given":"Srikantiah","family":"Chandrashekara","sequence":"additional","affiliation":[{"name":"ChanRe Rheumatology &amp; Immunology Center &amp; Research Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarath C. 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