PMS28 - Patient-Reported Outcomes from Phase 3 Baricitinib Ra-Beam Study: Latin American Subgroup Analysis

Abstract

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 an inadequate response to methotrexate (MTX). *LA countries: Argentina and Mexico. In the double-blind RA-BEAM study, 1305 patients with active RA on established methotrexate treatment were randomized in 3:3:2 to receive 4 mg BARI orally once daily, 40 mg adalimumab (ADA) subcutaneously once every 2 weeks, or matching placebo (PBO) for up to 52 weeks; the latter were switched to BARI at Week 24. Rescue treatment was provided to all nonresponders from Week 16. PROs were measured using Health Assessment Questionnaire-Disability Index (HAQ-DI), pain visual analog scale (VAS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Short Form-36 for 380 LA patients from baseline to Week 24 and were compared between treatments using ANCOVA for continuous variables and logistic models for categorical variables. Missing values were imputed using modified last observation-carried forward (mLOCF) for continuous variables and nonresponder imputation (NRI) for categorical variables. A total of 143 LA patients received BARI, 96 ADA, and 141 PBO. Baseline characteristics of These patients were comparable among the treatment groups with mean duration of RA of 9.9 years. Patients receiving BARI showed significantly (p<0.01) greater improvement compared to PBO in pain and HAQ-DI as early as Week 1. By Week 24, patients receiving BARI had statistically significant improvement (p<0.01) in pain, HAQ-DI, SF-36 physical component score (PCS), and FACIT-F compared to PBO. The percentage of patients who met/exceeded the MCID for the HAQ-DI (≥0.22), PCS ≥5, and MCS ≥5 was significantly (p<0.05) higher for BARI vs. PBO at Week 24. Significant improvement in PROs including physical function, pain, and fatigue was noted in patients treated with BARI versus PBO and numeric improvements were observed versus ADA.