Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Efficacy and safety of tofacitinib in Brazilian patients from Phase 2 (P2) and Phase 3 (P3) global studies of up to 24 months' duration were evaluated
Rheumatoid arthritis (RA) is a chronic, progressive, systemic inflammatory disease that mainly affects the synovial membranes of joints, eventually resulting in bone and cartilage destruction. The estimated prevalence of RA in Brazil is 0.5%, although regional differences exist and prevalence ranges from 0.2% to 1.0% in South East and North Brazil, respectively.
In order to expand the evidence base for the clinical use of tofacitinib as a treatment for RA in Brazil, we report the results of a pooled post-hoc analysis of efficacy and safety data from a cohort of Brazilian patients with RA who received tofacitinib 5 or 10 mg BID or placebo in global P2 and P3 studies.
Data were pooled from Brazilian patients with RA and an inadequate response to conventional synthetic or biologic disease-modifying antirheumatic drugs enrolled in P2/P3 tofacitinib studies who received tofacitinib 5 or 10 mg twice daily (BID), or placebo, as monotherapy or in combination with methotrexate. Efficacy, safety, and patient-reported outcomes were assessed over 24 months.
Patients (226) from Brazil were treated in tofacitinib global P2/P3 studies. At Month 3, there were improvements in American College of Rheumatology 20/50/70 response rates, Disease Activity Score in 28 joints, erythrocyte sedimentation rate, and Health Assessment Questionnaire-Disability Index scores with both tofacitinib doses.
Improvements from baseline in pain, fatigue, and health-related quality of life with tofacitinib 5 and 10 mg BID were reported. Efficacy improvements were sustained up to Month 24. The most frequent class of adverse events was infections and infestations. No cases of tuberculosis or other opportunistic infections were reported.
In a Brazilian subpopulation of patients with RA, tofacitinib reduced disease signs and symptoms and improved physical function up to Month 24, with a safety profile consistent with findings from global studies.