Patient-reported Outcomes from a Phase 3 Study of Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Secondary Analyses from the RA-BEAM Study
Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, Velasco Zamora J, Covarrubias Cobos JA, Rooney T, de Bono S, Arora V, Linetzky B, Weinblatt ME. - Ann Rheum Dis 2017;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259
This paper describes the patient-reported outcome (PRO) data collected in RA-BEAM, a Phase 3 study of baricitinib compared with both placebo and adalimumab in patients with RA and an inadequate response to MTX.
PRO measures evaluated include health-related quality of life (HRQOL), physical function, disability, fatigue, sleep, mental health status, work productivity and work activity impairment.
The RA-BEAM study demonstrated that patients treated with baricitinib experienced a greater improvement compared with patients treated with placebo or adalimumab in most PROs across different domains of RA, including physical function, morning joint stiffness, fatigue, pain and HRQOL. These improvements tended to occur within the first weeks of treatment and were maintained throughout the 52-week trial.
These data demonstrate treatment benefits, for patients receiving baricitinib, that appear clinically relevant.