POS0701 LONG-TERM EFFICACY OF BARICITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO HAVE HAD INADEQUATE RESPONSE TO csDMARDs: RESULTS FROM RA-BEYOND UP TO 7 YEARS OF TREATMENT

Abstract

Background: Baricitinib (BARI), an oral selective Janus kinase 1/2 inhibitor, has demonstrated efficacy in patients (pts) with rheumatoid arthritis (RA) for up to 3 years (yrs) in a long-term extension (LTE) study RA-BEYOND.1 Objectives: Disclose efficacy of BARI in csDMARD-IR pts in the completed LTE study (up to 7 yrs). Methods: In RA-BUILD, csDMARD-IR pts were randomized 1:1:1 to BARI 4 mg, 2 mg, or placebo (PBO). Completers to week (wk) 24 could enter the LTE and received BARI 4 or 2 mg. In RA-BEAM, MTX-IR pts were randomized 1:1:1 to BARI 4 mg, adalimumab (ADA) 40 mg, or PBO. Completers to wk 52 received BARI 4 mg in the LTE. Pts with no response could be rescued after wk 16 in both studies. Data were analysed by treatment assigned at baseline in originating studies as observed up to time of stepdown (if applicable), study discontinuation or completion, whichever occurred earlier. Efficacy response rates (RR) were assessed as proportions of pts with observed data up to yr 7 (wk 364) for low-disease activity (LDA) (SDAI ≤ 11, DAS28-hsCRP ≤ 3.2, CDAI ≤ 10), remission (REM) (SDAI ≤ 3.3, DAS28-hsCRP < 2.6, CDAI ≤ 2.8, Boolean), and physical function (HAQ-DI ≤ 0.5). No formal statistical comparisons were conducted. Results: Approximately 56%/25% of pts in BARI 4 mg, 80%/31% in BARI 2 mg, and 60%/25% in PBO from RA-BUILD remained active at yr 3/7; 59%/17% of pts in ADA, 54%/16% in BARI 4 mg, and 67%/14% in PBO from RA-BEAM remained active at year 3/7. SDAI and CDAI had comparable RR for LDA and REM (Table 1). DAS-28CRP LDA RR were similar to SDAI and CDAI, while REM RR were about twice those of SDAI and CDAI (Table 1). HAQ-DI ≤ 0.5 RR was achieved by 25-30% of BARI-treated pts from both trials and maintained to the end of LTE. Conclusion: In observed data, BARI demonstrated maintained efficacy in treatment and maintenance of physical function of a csDMARDs-IR RA pt population up to 7 yrs.