Patient-re ported outcomes from phase 3 baricitinib ra-begin study: Latin American subgroup analysis

Objectives: To evaluate effect of baricitinib (BARI) on patient-reported outcomes (PROs) in Latin American (LA)∗ patients with moderately to severely active rheumatoid arthritis (RA) with limited or no disease-modifying antirheumatic drug (DMARD) and naïve to biologic DMARDs. ∗LA countries: Argentina, Brazil, and Mexico. Methods: In the global 52-week, double-blind RA-BEGIN study, 584 patients were randomized to receive orally methotrexate (MTX) once weekly, 4 mg BARI daily, and 4 mg BARI plus MTX. Physical function, pain, fatigue, and quality of life (HRQOL) (Health Assessment Questionnaire-Disability Index [HAQ-DI], pain visual analog scale, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], and Short Form-36 [SF-36], respectively) for 169 LA patients from baseline to Week 24 were compared between treatments using ANCOVA. Missing values were imputed using modified last observation-carried forward (mLOCF). Results: Significantly greater improvement (p< 0.05) in HAQ-DI for patients treated with BARI monotherapy (mono) or combination therapy (combo) vs. patients treated with MTX mono was observed as early as Week 1 and at Week 24. Patients treated with BARI mono or combo also showed significantly greater (p< 0.05) improvements in pain and FACIT-F as early as Week 1. This result was maintained at Week 24 (p< 0.05) for the combination therapy in comparison with MTX monotherapy. Greater improvement in the mental and physical component scores of the SF-36 was observed in the BARI combo patients versus MTX mono (p< 0.05) at Week 24. No differences in any PROs were observed between BARI mono and combo at Week 24. ConClusions: This post hoc analysis of LA patients from RA-BEGIN shows improvement in PROs with BARI mono and significant improvement with BARI combo in comparison to MTX mono. The results from this subgroup of LA patients are similar with those observed in the global RA-BEGIN study.