A MULTINATIONAL, PROSPECTIVE, OBSERVATIONAL STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS RECEIVING BARICITINIB, TARGETED SYNTHETIC OR BIOLOGIC DISEASE-MODIFYING THERAPIES: 12 MONTH TIME TO DISCONTINUATION, EFFECTIVENESS AND PATIENT REPORTED OUTCOME DATA FROM THE EUROPEAN COHORT

Background: Baricitinib (BARI), an oral selective JAK 1/2 inhibitor, is approved for treating adults with moderate to severe active rheumatoid arthritis (RA). RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with RA evaluating time to discontinuation of initial RA treatment for all causes (excluding sustained clinical response) over 24 months (M). Objectives: This analysis reports time to discontinuation in the European (France, Germany, Italy, Spain, UK) subgroup, treated with either BARI, biologic (b) disease-modifying anti-rheumatic drugs (DMARDs) or any other targeted synthetic (ts)DMARDs, as well as, the effectiveness of RA treatment, at 12M. Methods: In the two cohorts, patients were initiated with BARI 2-mg or 4-mg (cohort A), or any bDMARD or tsDMARD (b/tsDMARDs; cohort B). Treatment initiation and changes are at the discretion of the patient or physician. Response rates for remission, low disease activity (LDA), moderate disease activity (MDA) or high disease activity (HDA) were determined using the Clinical Disease Activity Index (CDAI) at 12M. Quality of life using the EQ-5D-5L and patient reported outcome (PRO) measures for pain (pain visual analogue scale; VAS) and physical functioning (Health Assessment Questionnaire Disability Index; HAQ-DI) were also assessed at 12M. This pre-specified interim analysis reports descriptive 12M data using summary statistics, without any inferential testing. Results: This analysis involved 1073 adult RA patients with a mean age (standard deviation; SD) of 59.1 (13.2) (cohort A) and 57.0 (13.9) yrs (cohort B), respectively, and a mean disease duration (SD) of 10.0 (9.1) (cohort A) and 8.9 (9.6) yrs (cohort B), respectively. At baseline, 50.9% of patients in cohort A and 31.2% in cohort B initiated treatment as a monotherapy. At 12M, 26.7% of patients in cohort A and 44.1% of patients in cohort B had discontinued treatment. The most common reason for discontinuation in both cohorts was primary non-response. At 12M, 24.1% of patients in cohort A and 16.6% in cohort B achieved CDAI remission ( Figure 1 ). The mean CDAI reduction was -14.5 and -12.0, respectively in cohorts A and B. Mean reductions from baseline in physician global assessment (PhGA) and in patient global assessment (PGA) were -3.4 and -2.5, respectively in cohort A and -3.0 and -2.1, respectively in cohort B. Improvements from baseline in EQ-5D-5L, HAQ-DI, and pain (VAS) were reported in both cohorts at 12M. The mean pain (VAS) reduction from baseline was -24.6 and -19.3 in cohort A and cohort B, respectively. Figure 1. Percentage of pts in cohorts A and B achieving remission and LDA at 12M Conclusion: The majority of BARI-treated patients were in remission or had low disease activity and continued treatment at 12M. Table 1. Disease activity and patient reported outcomes at baseline and 12M Cohort A Baricitinib Cohort B b/tsDMARDs Baseline 12M CFB Baseline 12M CFB CDAI 24.0 (11.7) 9.1 (8.2) -14.5 (12.4) 23.8 (12.4) 10.7 (9.8) -12.0 (12.6) SJC 5.2 (4.8) 1.3 (2.4) -3.9 (4.8) 4.7 (4.9) 1.3 (2.8) -3.0 (4.6) TJC 7.3 (6.1) 2.2 (3.6) -4.7 (6.0) 7.8 (6.5) 3.0 (4.8) -4.0 (6.1) PhGA 5.6 (2.0) 2.3 (2.1) -3.4 (2.5) 5.5 (2.1) 2.5 (2.1) -3.0 (2.6) PGA 5.9 (2.3) 3.4 (2.5) -2.5 (2.9) 5.8 (2.4) 3.8 (2.6) -2.1 (3.0) HAQ-DI 1.4 (0.7) 1.0 (0.8) -0.4 (0.6) 1.3 (0.7) 1.0 (0.8) -0.3 (0.6) Pain (VAS ) 59 (23.1) 33.2 (26.2) -24.6 (28.7) 56.5 (24.3) 36.6 (26.5) -19.3 (30.4) EQ-5D-5L 0.5 (0.3) 0.7 (0.2) 0.1 (0.3) 0.5 (0.3) 0.7 (0.2) 0.1 (0.3) Values represent observed mean (SD) b/tsDMARDs; biologic/targeted synthetic disease-modifying anti-rheumatic drugs, CFB; change from baseline, CDAI; clinical disease activity index, SJC; swollen joint count, TJC; tender joint count, P(h)GA; patient (physician) global assessment of disease activity, HAQ-DI; health assessment questionnaire disability index, VAS; visual analogue scale (mm), EQ-5D-5L; European quality of life 5 dimensions 5 levels Disclosure of Interests: Rieke Alten Speakers bureau: Eli Lilly and Company, Pfizer, Galapagos, Consultant of: Eli Lilly and Company, Pfizer, Galapagos, Grant/research support from: Eli Lilly and Company, Pfizer, Galapagos, Gerd Rüdiger Burmester Speakers bureau: Amgen, AbbVie, BMS, Galapagos, Eli Lilly and Company, MSD, Pfizer, Roche, Sanofi, Consultant of: Amgen, AbbVie, BMS, Galapagos, Eli Lilly and Company, MSD, Pfizer, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Biogen, Eli Lilly and Company, Grant/research support from: Actelion, Biogen, Novartis, MSD, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Eli Lilly and Company, Novartis, Pfizer, UCB, Gilead, Paradigm, Liliana Zaremba-Pechmann: None declared, Marta Herrera Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Kathy Gibson Speakers bureau: UCB, Consultant of: Janssen, Novartis, Grant/research support from: Novartis, Employee of: Eli Lilly and Company, Tamas Treuer Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jens Gerwien Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Bruno Fautrel Consultant of: AbbVie, Biogen, BMS, Celgene, Janssen, Eli Lilly and Company, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, SOBI, UCB, Grant/research support from: AbbVie, MSD, Pfizer, Eli Lilly and Company Citation: , volume 81, supplement 1, year 2022, page 606Session: Rheumatoid arthritis - non biologic treatment and small molecules (POSTERS only)