THU0609 Patient-Reported Outcomes from A Phase 3 Study of Baricitinib versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis and An Inadequate Response To Background Methotrexate Therapy

BackgroundBaricitinib (bari), an oral JAK1 and JAK2 inhibitor, was efficacious in a Ph 3 study (RA-BEAM) in RA patients (pts) with active disease and an inadequate response (IR) to MTX.1ObjectivesTo evaluate patient-reported outcomes (PROs) from RA-BEAM.MethodsPts on stable background MTX were randomized to placebo (PBO), bari 4 mg QD, or adalimumab (ADA) 40 mg Q2W. PROs listed in the table and the Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) were collected on electronic tablets during study visits. Bari vs. PBO and bari vs. ADA were assessed with ANCOVA and logistic regression models.Results1305 pts were randomized. Functional disability at baseline (mean HAQ-DI) was: 1.55, 1.57, 1.59 for PBO, bari, and ADA, respectively. Compared to PBO, bari was superior in physical function, Pt's Global Assessment of Disease Activity (PtGDA), pain, fatigue and quality of life (physical component score [PCS]), at Wk 12 and 24. Compared to ADA, bari was superior in physical function, PtGDA, and pain at Wks 12, 24 and 52. Compared to PBO, a similar proportion of bari and ADA pts were employed throughout the study. Statistically significant improvements in all components of the WPAI-RA (absenteeism, presenteeism, work productivity loss and activity impairment) were seen in the bari pts compared to PBO at Wk 12; statistically significant improvements were seen for work loss and activity impairment for bari pts compared to ADA at Wk 12.Table 1.PRO measures, LSM change from baseline (unless noted)Wk 12Wk 24Wk 52PBO (N=488)Bari 4 mg (N=487)ADA (N=330)PBO (N=488)Bari 4 mg (N=487)ADA (N=330)Bari 4 mg (N=487)ADA (N=330)Physical function (HAQ-DI) [% with MCID ≥0.22]−0.34 [58]−0.65***++ [75***]−0.55*** [71***]−0.34 [45]−0.72***++ [73***+]−0.61*** [64***]−0.73+ [68++]−0.64 [58]Pt's Global Assessment of Disease Activity−16.7−31.2***++−26.6***−17.0−33.1***+−29.1***−36.3+++−30.3Pt's Assessment of Pain−17.1−31.5***++−26.4***−17.5−33.6***++−28.8***−36.1+++−30.3Fatigue (FACIT-F) [% with MCID ≥3.56]6.7 [59]9.1*** [66*]8.7*** [68**]6.5 [43]10.0*** [65***+]9.3*** [59***]10.7+ [60]9.3 [54]QoL: SF-36 PCS [% with MCID ≥5];4.2 [40];8.7***++ [65***+];7.2*** [56***];4.6 [36];9.7***++ [65***];7.9*** [57***];10.4++ [60+];8.6 [52]; MCS [% with MCID ≥5]3.1 [33]3.4 [37]3.3 [37]2.2 [28]3.8** [38**]3.3 [34]4.3 [34]3.4 [29]LSM: least-squares mean; MCID: minimum clinically important difference; MCS: mental component score; *p≤0.05, **p≤0.01, ***p≤0.001 vs. PBO; +p≤0.05, ++p≤0.0