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The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis

Authors :
Rieke Alten
Gerd R. Burmester
Marco Matucci-Cerinic
Jean-Hugues Salmon
Pedro Lopez-Romero
Walid Fakhouri
Inmaculada de la Torre
Liliana Zaremba-Pechmann
Thorsten Holzkämper
Bruno Fautrel
Source :
Rheumatology and Therapy, Vol 10, Iss 1, Pp 73-93 (2022)
Publication Year :
2022
Publisher :
Adis, Springer Healthcare, 2022.

Abstract

Abstract Introduction RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time until discontinuation from any cause (excluding sustained response) of the initial treatment. Methods RA-BE-REAL is an ongoing, prospective, observational, 36-month study in patients with RA initiating treatment with baricitinib (cohort A) or any other tsDMARD or any bDMARD (cohort B) for the first time. The primary objective is to assess the time until treatment discontinuation from any cause (excluding sustained response) at 24 months, (i.e., the rate of discontinuation of initial baricitinib or ts/bDMARD). Patient profiles of each cohort are described and compared. Post-baseline data are descriptively analyzed. This manuscript presents baseline and interim (6-month) outcomes for European patients with RA participating in the global RA-BE-REAL study. Results Data from 1074 patients (cohort A: 509; cohort B: 565) were analyzed. For cohorts A and B, respectively, the 6-month cumulative incidence (95% confidence interval) of treatment discontinuation was 16.5 (12.9–21.1) and 23.3 (19.1–28.2), and the proportions of patients achieving remission were 25.6% and 18.5%. At baseline, mean patient age was 59.1 and 57.0 years (p = 0.010) and mean disease duration was 10.0 and 8.9 years (p = 0.047), respectively. The proportions of patients exposed to ts/bDMARDs at any time before study entry were 51.9% and 39.1%, and the proportions of patients initiated on monotherapy were 50.9% and 31.2%, respectively. Conclusion In real-world settings, patients with RA initiating treatment with baricitinib were older and had longer disease duration than those initiating treatment with any other tsDMARD or any bDMARD. Initial descriptive data regarding treatment discontinuation (including reasons for discontinuation), effectiveness, and treatment patterns will be enriched as the study progresses.

Details

Language :
English
ISSN :
21986576 and 21986584
Volume :
10
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Rheumatology and Therapy
Publication Type :
Academic Journal
Accession number :
edsdoj.b9bdc473f0647a5848b4e5f65379efc
Document Type :
article
Full Text :
https://doi.org/10.1007/s40744-022-00500-6