Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long‐term extension studies over 7 years

摘要: OBJECTIVES Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest world (ROW; excluding India) RA patients. METHODS Efficacy data were pooled disease-modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For patients, ORAL Solo and Scan; ROW (excluding India), these studies plus Step, Sync, Standard. Safety also included Start (P3; methotrexate-naive) Sequel (long-term extension [LTE] study; cut-off March 2017) A3921041 (LTE Japanese study) ROW. outcomes at months 3/6: American College Rheumatology (ACR)20/50/70; Disease Activity Score 28 joints, erythrocyte sedimentation rate remission/low disease activity; change baseline Health Assessment Questionnaire-Disability Index. Incidence rates (IRs; patients with events/100 patient-years) adverse events special interest (AESIs) assessed throughout. Descriptive underwent no formal comparison. RESULTS One-hundred-and-ninety-seven 3879 included. Compared younger, had lower body mass index, shorter duration, higher most non-smokers all biologic DMARD (bDMARD)-naive. Month 3 ACR20 5 mg twice daily/10 mg daily/placebo 67.4%/82.1%/40.9% (India) 59.0%/66.1%/28.2% (ROW), month 6 76.2%/92.1%/88.9% 69.0%/74.2%/66.5% (ROW). 3/6 improvements other generally numerically greater placebo, similar both populations. ROW, fewer AEs/serious AEs, IRs discontinuations due to AEs AESIs, except that tuberculosis (TB) IR was (IR = 1.21; 95% CI 0.49, 2.49) (IR = 0.17; 0.11, 0.25). CONCLUSIONS populations, TB IR, which but line those bDMARD-treated high-risk countries (IR = 0.00-2.56; >0.05 [World Organization]). Limitations small population differences between