Summary of baricitinib effect on patientreported outcomes (PROS) in methotrexateinadequate responder patient population

Background: In addition to assessment by physical examination, laboratory tests and imaging, Patient-Reported Outcomes (PROs) have become increasingly important in the evaluation of rheumatoid arthritis (RA) patients (pts). The objective is to summarise the effect of baricitinib (BARI) treatment on PROs compared to adalimumab (ADA) or placebo (PBO) in patients with inadequate response to methotrexate (MTX). Methods: In RA-BEAM (NCT01710358), 1305 patients with inadequate response to MTX were randomised 3:3:2 to PBO QD, BARI 4mg QD, or ADA 40mg EOW. Post-hoc analyses of RA-BEAM focused on different aspects of the impact of BARI on PRO measures for physical function, fatigue, and pain such as the visual analogue scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS): the proportion of patients (Table Presented) who, at different time points, achieved pain improvement of≤50% of their baseline (BL) pain (

VAS:

0-100mm) in each treatment arm; differences in PROs, at week (Wk) 24, among patients with DAS28-ESR defined low disease activity (LDA) and remission in each treatment group. Results: A significantly greater proportion of patients treated with BARI 4mg achieved ≤50% pain improvement as early as Wk1 compared to PBO (26% vs 13%; p≥0.001) and as early as Wk4 compared to ADA (48% vs 37%; p≥0.01); improvements were sustained through Wk24 (BARI 61% vs ADA 52%; p≥0.05). Patients in LDA at Wk24 who were treated with BARI 4mg reported significantly greater improvements in pain and HAQ-DI than those with ADA and PBO (Table). Among patients in remission at Wk24, significantly greater improvements in HAQ-DI scores were reported with BARI than with PBO; among patients with LDA, significantly greater improvements in morning joint stiffness duration were also observed with BARI and ADA than with PBO (Table 1). Conclusion: BARI demonstrated rapid and sustained improvements in pain. Attainment of remission or LDA is associated with improvements in pain, physical functioning and health-related quality of life (QOL) for patients treated with BARI, ADA or PBO but with most marked improvements on BARI and ADA.