Patient-reported outcomes from a phase 3 study of baricitinib in patients with rheumatoid arthritis (RA) and an inadequate response to tumor necrosis factor inhibitors

Background: In ph 2 studies, baricitinib (bari) improved disease activity with an acceptable safety profile in pts with active RA naïve to biologic DMARDs (bDMARDs).1,2 Objectives: To report patient-reported outcomes (PRO) from a ph 3 study of bari in pts with active RA on 1 or 2 conventional DMARDs (cDMARDs) and an inadequate response or intolerance to ≥1 TNF inhibitors. Methods: Pts were randomized 1:1:1 to placebo (PBO) or bari (2 or 4 mg) QD for 24 wks. PROs are listed in the table. Analyses included ANCOVA, logistic regression, and nonparametric methods and compared bari 2 or 4 mg vs. PBO. Results: 527 pts were randomized. Assessment of PROs at baseline revealed severe impairment of physical function (

HAQ-DI:

1.7-1.8) and QoL. Bari 2 and 4 mg resulted in statistically significant improvements from baseline vs. PBO in most PROs at 24 wks (Table). Conclusions: In this ph 3 study of pts with active RA on cDMARDs and an inadequate response to bDMARDs, bari was associated with significant improvement in most PROs through 24 wks compared to PBO. (Table Presented).