Tofacitinib, an oral Janus kinase inhibitor, in patients from Colombia with rheumatoid arthritis: Pooled efficacy and safety analyses of data from phase III studies

Introduction: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Objective: To conduct a post hoc analysis of tofacitinib efficacy and safety in Colombian patients enrolled in global phase III studies. Methods: Data were pooled from Colombian patients with RA across four phase III tofacitinib studies: ORAL Sync, ORAL Scan, ORAL Solo, and ORAL Start. Patients received tofacitinib 5 or 10 mg twice daily, methotrexate (ORAL Start only), or placebo as single therapy (ORAL Start and ORAL Solo), or in combination with csDMARDs (ORAL Sync and ORAL Scan). Data were pooled from three studies with similar patient populations (Sync, Scan, Solo) for efficacy analyses, and from all studies for safety analyses, up to Month 24. The efficacy analysis excluded ORAL Start due to the methotrexate-naive patient population, and placebo and methotrexate groups, due to low patient numbers. Results: Data pooled included 77 patients for efficacy, and 125 for safety analyses. Tofacitinib-treated patients showed improved American College of Rheumatology 20/50/70 response rates, a mean Disease Activity Score 28-4 (erythrocyte sedimentation rate), and a mean change from baseline in Health Assessment Questionnaire-Disability Index. Improvements were sustained in Months 12–24, although patient numbers were low post-Month 12. The most frequently reported adverse events were anemia, headache, influenza, and increased blood creatine phosphokinase. No tuberculosis cases, serious adverse events, or deaths were reported, and few cases of herpes zoster or malignancies occurred. Conclusions: Tofacitinib reduced RA signs and symptoms, and improved physical function. The efficacy and safety of tofacitinib in this Colombian sub-population were consistent with data from global phase III studies.