Patient-reported outcomes from a phase 3 study of baricitinib in patients with early rheumatoid arthritis who had received limited or no treatment with disease-modifying anti-rheumatic drugs

Background: Baricitinib (bari), an oral JAK1 and JAK2 inhibitor, was efficacious in a Ph 3 study (RA-BEGIN) in RA patients (pts) who had limited or no exposure to methotrexate (MTX) and who were naïve to other csDMARDs and bDMARDs.1 Objectives: To evaluate patient-reported outcomes (PROs) from RA-BEGIN. Methods: Pts were randomized to MTX QW, bari 4 mg QD, or bari 4 mg QD+MTX QW. PROs listed in the table and the Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire were collected on electronic tablets during study visits. Bari vs. MTX and bari+MTX vs. MTX were assessed with ANCOVA and logistic regression models. Results: 584 pts were randomized. Mean baseline PROs for MTX, bari, and bari+MTX, respectively, were

HAQ-DI:

1.67, 1.64, 1.58; Pt's Global Assessment of Disease Activity (PtGDA):65.6, 65.0, 63.1; pt assessment of pain:65.2, 64.1, 62.6. Compared to MTX, bari and bari+MTX were superior in physical function, PtGDA, pain, and fatigue at Wks 24 and 52. Statistically significant improvements in all components of the WPAI-RA (absenteeism, presenteeism, work productivity loss and activity impairment) were seen in the bari and bari+MTX pts vs. MTX at Wk 24; statistically significant improvements were seen for work loss for bari+MTX vs. MTX at Wk 52 and for activity impairment for bari and bari+MTX vs MTX at Wk 52. Conclusions: In this Ph 3 study of pts with early active RA, bari alone or with MTX was associated with significant improvements at 24 and 52 wks compared to MTX in most PROs.