TY - JOUR T1 - Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies JO - Reumatología Clínica (English Edition) T2 - AU - Burgos-Vargas,Ruben AU - Cardiel,Mario AU - Xibillèc),Daniel AU - Pacheco-Tena,Cèc)sar AU - Pascual-Ramos,Virginia AU - Abud-Mendoza,Carlos AU - Mahgoub,Ehab AU - Rahman,Mahboob AU - Fan,Haiyun AU - Rojo,Ricardo AU - García,Erika AU - Santana,Karina SN - 21735743 M3 - 10.1016/j.reumae.2017.04.009 DO - 10.1016/j.reumae.2017.04.009 UR - https://www.reumatologiaclinica.org/en-tofacitinib-an-oral-janus-kinase-articulo-S2173574319300048 AB - ObjectivesTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. MethodsData from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. Results119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. ConclusionsIn Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population. ER -