P125 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
Authors: Caporali Roberto , Aletaha Daniel , Sanmartí Raimon , Takeuchi Tsutomu , Mo Daojun , Haladyj Ewa , Zaremba-Pechmann Liliana , Taylor Peter C 
Published: April 2023

Abstract

Background/Aims
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. This analysis reports 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 &lt; 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.
Disclosure
R. Caporali: Consultancies; R. C. has been a consultant and/or speaker for: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Fresenius Kabi, Galapagos NV, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, and UCB Pharma. D. Aletaha: Grants/research support; D. A. has been a speaker for and/or has received research support from: AbbVie, Amgen, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, and Sobi. R. Sanmartí: Grants/research support; R. S. has been a speaker for and has received research support from: Eli Lilly and Company. T. Takeuchi: Grants/research support; T. T. has been a consultant and/or speaker for and/or has received research support from: AbbVie, Asahi Kasei Pharma, Astellas, AYUMI Pharmaceutical, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, DNA Chip Research, Eisai, Eli Lilly Japan K.K., Gilead Sciences, Janssen, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma. D. Mo: Shareholder/stock ownership; D. M. is an employee and shareholder of: Eli Lilly and Company. E. Haladyj: Shareholder/stock ownership; E. H. is an employee and shareholder of: Eli Lilly and Company. L. Zaremba-Pechmann: Other; L. Z-P. is a contractor for: HaaPACS GmbH. P.C. Taylor: Grants/research support; P. C. T. has been a consultant for and/or has received research support from: AbbVie, Biogen, Celgene, Eli Lilly and Company, Fresenius Kabi, Galapagos NV, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer, Roche, and Sanofi.