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

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

doi:10.1007/s40744-022-00500-6

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

Rheumatol Ther. 2023 Feb;10(1):73-93. doi: 10.1007/s40744-022-00500-6. Epub 2022 Oct 13.

Authors

Affiliations

¹ Department of Internal Medicine and Rheumatology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany. Rieke.Alten@schlosspark-klinik.de.
² Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.
³ Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Milan, Italy.
⁴ Department of Experimental and Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Florence, Italy.
⁵ Faculty of Medicine, University of Reims Champagne-Ardenne, UR 3797, 51095, Reims, France.
⁶ Rheumatology Department, Maison Blanche Hospital, Reims University Hospitals, 51092, Reims, France.
⁷ Eli Lilly and Company, Indianapolis, IN, USA.
⁸ HaaPACS, Schriesheim, Germany.
⁹ Department of Rheumatology, Pitie Salpetriere Hospital, Sorbonne University-Assistance Publique Hôpitaux de Paris, Paris, France.
¹⁰ PEPITES Team, Pierre Louis Institute of Epidemiology and Public Health, INSERM UMRS, 11376, Paris, France.

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.

Keywords: Baricitinib; Effectiveness; Patient-reported outcomes; Rheumatoid arthritis; Treatment discontinuation observational study; bDMARDs; tsDMARDs.