THU0623 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

BackgroundBaricitinib (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.1ObjectivesTo evaluate patient-reported outcomes (PROs) from RA-BEGIN.MethodsPts 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.Results584 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.Table 1.PRO measures, Least Squares Mean change from baseline (unless noted)Wk 24Wk 52MTX (N=210)Bari 4 mg (N=159)Bari 4 mg + MTX (N=215)MTX (N=210)Bari 4 mg (N=159)Bari 4 mg + MTX (N=215)Physical function (HAQ-DI) [% with MCID ≥0.22]−0.72 [70]−1.00*** [81*]−0.95*** [79*]−0.66 [57]−0.88** [68*]−0.94*** [72***]PtGDA−30.5−41.1***−39.9***−29.0−40.4***−42.6***Pt Assessment of Pain−30.0−40.8***−41.2***−30.7−40.3***−43.4***Fatigue (FACIT-F) [% with MCID ≥3.56]8.9 [65]13.3*** [76*]12.2*** [71]8.9 [54]11.7** [62]12.6*** [62]QoL: SF-36 PCS [% with MCID ≥5];10.0 [62];13.8*** [71];13.6*** [74*];11.1 [48];13.0 [65**];14.5*** [65***]; MCS [% with MCID ≥5]3.8 [32]5.4 [41]4.7 [41]3.5 [29]5.1 [33]5.3 [37]MCID, minimum clinically important difference; M/PCS, mental/physical component score; VAS, visual analog scale; *p≤0.05, **p≤0.01, ***p≤0.001 vs. MTX.ConclusionsIn 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.ReferencesFleischmann et al. Arthritis Rheumatol 2015;67(S10)Disclosure of InterestM. Schiff Consultant for: AbbVie, Amgen