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

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.

Fig. 1

Cumulative incidence of discontinuation of RA treatment over 6 months in cohort A (baricitinib) and cohort B (ts/bDMARDs). Cumulative incidence developed with reverse Kaplan–Meier estimate. Patients with sustained clinical response were excluded from the primary outcome analysis. Patients who were lost to follow-up for any reason, including death, were censored at the last observation available. bDMARD biologic disease-modifying antirheumatic drug, CI confidence interval, RA rheumatoid arthritis, tsDMARD targeted synthetic disease-modifying antirheumatic drug

Fig. 2

Proportions of patients with CDAI remission and low, moderate, and high disease activity, at baseline and after 6 months of RA treatment with baricitinib (cohort A) and ts/bDMARDs (cohort B). Proportions of patients are calculated using as the denominator the number of patients with available CDAI data at baseline and 6 months and for each cohort. CDAI score categories were as follows: remission 0.0–2.8, low disease activity 2.9–10.0, moderate disease activity 10.1–22.0, and high disease activity 22.1–76.0. [23]. bDMARD biologic disease-modifying antirheumatic drug, CDAI Clinical Disease Activity Index, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, RA rheumatoid arthritis, tsDMARD targeted synthetic disease-modifying antirheumatic drug