P197 A multinational, prospective, observational study in patients with rheumatoid arthritis receiving baricitinib, targeted synthetic or biologic disease-modifying therapies: 6-month effectiveness and patient-reported outcome data from the European cohort. (23rd April 2022)

• Record Type: Journal Article
• Authors: Kiprianos, Allan; Alten, Rieke; Burmester, Gerd; Matucci-Cerinic, Marco; Salmon, Jean-Hugues; Lopez-Romero, Pedro; Fakhouri, Walid; de la Torre, Inmaculada; Gentzel-Jorczyk, Anja; Holzkämper, Thorsten; Fautrel, Bruno
• Is Part Of: Rheumatology. Volume 61(2022)Supplement 1
• Publication Date: 2022-04-23
• Subjects: Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keac133.196
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Background/Aims: Baricitinib (BARI) is a JAK1/2 inhibitor approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) and the treatment of atopic dermatitis in Europe and Japan. RA-BE-REAL is a 3-year, prospective, observational study of adult RA patients evaluating adherence to treatment in clinical practice. Objectives: To report the proportion of European patients with RA that discontinue treatment following 3 and 6 months (M) of either BARI, biologic (b)DMARDs or any other targeted synthetic (ts)DMARDs (b/tsDMARDs) after starting that treatment for the first time. To report the percentage of patients achieving remission and low disease activity (LDA) based on Clinical Disease Activity Index (CDAI) at 6M. To assess changes from baseline in CDAI and to describe changes in patient-reported outcomes (PROs) related to quality of life, pain, and physical functioning at 6M. Methods: The primary endpoint is the discontinuation rate of initial RA treatment for all causes (excluding sustained clinical response) over a 24M period. Two patient cohorts are assessed: Cohort A, started treatment with BARI (2mg or 4mg), and Cohort B, any biologic or any other tsDMARD. Treatment initiation and changes are at the discretion of the patient or physician. In this interim analysis we report descriptive baseline, 3M and 6M data. Results: Between October 2018 and March 2020, 1074 adult RA patients were enrolled from France, Germany, Italy, Spain, and UK. At time of enrollment 50.9% of patients in Cohort A and 31.2% of patients in Cohort B commenced treatment as a monotherapy. A similar proportion of patients in Cohort A (52/392 patients; 13.3%) and Cohort B (59/425; 13.9%) discontinued treatment at 3M. At 6M patients in Cohort A (63/336; 18.8%) were less likely to have discontinued their initial RA treatment than patients in Cohort B (93/370; 25.1%). At 6M a higher percentage of Cohort A patients had achieved CDAI remission (Cohort A; 25.6%, Cohort B; 18.5%). Patients in Cohort A experienced a greater decrease in disease activity as assessed by CDAI, with a mean reduction in disease activity scores of − 13.9 (−11.8 for patients in Cohort B). With respect to PROs, a similar improvement from baseline in HAQ-DI, pain (VAS), and EQ-5D-5L scores was observed for both cohorts. Conclusion: Overall, these observational study results highlight that patients receiving baricitinib are less likely to discontinue treatment and more likely to achieve remission than patients receiving a biologic or any other tsDMARDs. Disclosure: A. Kiprianos (Non-Author Presenter): Shareholder/stock ownership; Eli Lilly and Company. R. Alten: Consultancies; Eli Lilly and Company, Galapagos NV, Janssen, and Pfizer. G. Burmester: Consultancies; Eli Lilly and Company, Janssen, Novartis, and Pfizer. Grants/research support; Eli Lilly and Company. M. Matucci-Cerinic: Consultancies; Acceleron Pharma, Actelion, Bayer Pharmaceuticals, Biogen, Boehringer Ingelheim, Chemomab Therapeutics, Corbus Pharmaceuticals, CSL Behring, Eli Lilly and Company, Galapagos NV, Inventiva, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Pfizer, Regeneron, Roche, and Samsung. Honoraria; Acceleron Pharma, Actelion, Bayer Pharmaceuticals, Biogen, Boehringer Ingelheim, Chemomab Therapeutics, Corbus Pharmaceuticals, CSL Behring, Eli Lilly and Company, Galapagos NV, Inventiva, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Pfizer, Regeneron, Roche, and Samsung. Grants/research support; Actelion, Biogen, Janssen, and Merck Sharp & Dohme. J. Salmon: Consultancies; AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Galapagos NV, Janssen, Medac, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Roche, Sanofi, and UCB Pharma. Member of speakers' bureau; AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Galapagos NV, Janssen, Medac, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Roche, Sanofi, and UCB Pharma. Other; Board member: AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Galapagos NV, Janssen, Medac, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Roche, Sanofi, and UCB Pharma. P. Lopez-Romero: Shareholder/stock ownership; Eli Lilly and Company. W. Fakhouri: Shareholder/stock ownership; Eli Lilly and Company. I. de la Torre: Shareholder/stock ownership; Eli Lilly and Company. A. Gentzel-Jorczyk: Shareholder/stock ownership; Eli Lilly and Company. T. Holzkämper: Shareholder/stock ownership; Eli Lilly and Company. B. Fautrel: Consultancies; AbbVie, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Medac, Merck Sharp & Dohme, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, Sobi, and UCB Pharma. Grants/research support; AbbVie, Eli Lilly and Company, Merck Sharp & Dohme, and Pfizer.