Time to Discontinuation and Effectiveness of Baricitinib in Rheumatoid Arthritis: 12-Month European Data from a Multinational, Prospective, Observational Study

Background/Aims RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with rheumatoid arthritis (RA) evaluating time-to-discontinuation of initial RA treatment. Baricitinib (BARI), an oral selective JAK1/2 inhibitor, is approved for the treatment of adults with moderate-to-severe active RA. This analysis reports time-to-discontinuation and effectiveness in patients with RA enrolled in Europe following 12M of either BARI, a biologic (b) disease-modifying anti-rheumatic drug (DMARD) or any other targeted synthetic (ts)DMARD, after starting that treatment for the first time. Methods Two cohorts were assessed: patients in cohort A initiated treatment with BARI (2-mg or 4-mg as monotherapy or in combination with any csDMARD) while patients in cohort B initiated any bDMARD (tumour necrosis factor inhibitors [TNFi] or non-TNFi bDMARD) or any other tsDMARD for the first time. Treatment initiation and changes were at the discretion of patient or physician. Time-to-discontinuation for patients in both cohorts were analysed in both bDMARD-naïve and -experienced patients. Response rates for remission and low disease activity (LDA) were determined using the Clinical Disease Activity Index at 12M. Steroid use was collected for both cohorts. This pre-specified interim analysis reports descriptive 12M data using summary statistics, without any inferential testing. Results At 12M, a similar percentage of patients discontinued 2-mg (25.4%) and 4-mg (26.9%) BARI whether as monotherapy (24.7%) or as combination therapy with any csDMARD (28.8%). In cohort B, 42.2%, 44.7%, and 52.3% of patients using TNFi, non-TNFi, and any other tsDMARD, respectively, discontinued treatment at 12M. In both cohorts, patients naïve to b/tsDMARD were least likely to discontinue treatment while those who had more than two previous b/tsDMARD treatments were most likely to discontinue. The most common reasons for discontinuation were primary non-response (Cohort A: 6.3%; Cohort B: TNFi: 8.3%, non-TNFi: 10.6%, any other tsDMARD: 10.6%) and adverse events (Cohort A: 6.3%; Cohort B: TNFi: 5.1%, non-TNFi: 7.5%, any other tsDMARD: 13.6%). At 12M, remission rates were 21.8%, 18.0%, 4.0%, and 18.2% for those on monotherapy treatment with BARI, TNFi, non-TNFi, and any other tsDMARD, respectively. For combination therapy, remission rates were 26.2%, 19.0%, 15.9%, and 13.6% for BARI, TNFi, non-TNFi, and any other tsDMARD treated patients, respectively. At 12M, 31.8% and 36.0% of patients in cohort A and B, respectively, reported ongoing steroid use, a reduction of 25.9% and 18.0%, respectively, from baseline. Conclusion Despite an older and more bDMARD experienced population, discontinuation rates were lower while remission was higher for those treated with BARI than those in cohort B. Discontinuation rate was consistent irrespective of BARI dose or if used in monotherapy or combination therapy. Discontinuation rates increased with number of previous b/tsDMARD in both cohorts, with numerically lower discontinuation rates at 12M for patients treated with BARI. Disclosure R. Alten: Grants/research support; R. A. has been a consultant for and/or received grant/research support from: AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. G.R. Burmester: Consultancies; G. R. B. has been a consultant for and/or received honoraria as a speaker for: AbbVie, Eli Lilly and Company, Galapagos, Gilead, Janssen, MSD, Pfizer, Roche, and UCB. M. Matucci-Cerinic: Corporate appointments; M. M-C. has been an officer or board member for: Biogen. Consultancies; M. M-C. has been a consultant for: Behring, Chemomab, Janssen, and Pfizer. Honoraria; M. M-C. has received honoraria as a speaker for: Eli Lilly and Company, and Sandoz. Grants/research support; M. M-C. has received grant/research support from: Merck, and MSD. A. Ostor: Consultancies; A. O. has been an advisor, review panel member, and/or consultant for: Abbot, AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Gilead, Janssen, Novartis, Paradigm, Pfizer, Roche, and UCB. L. Zaremba-Pechmann: Other; L. Z-P. is a contractor for: HaaPACS GmbH. T. Treuer: Shareholder/stock ownership; T. T. is an employee and shareholder of: Eli Lilly and Company. K. Ng: Shareholder/stock ownership; K. J. N. is an employee and shareholder of: Eli Lilly and Company. J. Gerwien: Shareholder/stock ownership; J. G. is an employee and shareholder of: Eli Lilly and Company. K.A. Gibson: Consultancies; K. A. G. has been a consultant for: Janssen, and Novartis. Shareholder/stock ownership; K. A. G. is an employee and shareholder of: Eli Lilly and Company. Honoraria; K. A. G. has received honoraria as a speaker for: UCB. Grants/research support; K. A. G. has received grant/research support from: Novartis. B. Fautrel: Grants/research support; B. F. has received research grants from AbbVie, Lilly, MSD and Pfizer, and consultancy fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Viatris. T. Sheeran (Non-Author Presenter): None.