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Abstract Number: 1348

Real World Evaluation on the Effectiveness of Baricitinib or Other Treatments in Patients With Rheumatoid Arthritis: Data from the European and Non-European Cohorts of the RA-BE-REAL Study

Rieke Alten1, Gerd Burmester2, Marco Matucci-Cerinic3, Jens Gerwien4, Walid Fakhouri4, Samuel Ogwu4, Ewa Haladyj4, Inmaculada De La Torre4, Bruno Fautrel5 and AJ Fernandez4, 1SCHLOSSPARK KLINK, Teaching Hospital of University Medicine Berlin, Department of Internal Medicine and Rheumatology, Berlin, Germany, 2Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 3University San Raffaele Milano, Milano, Milan, Italy, 4Eli Lilly and Company, Indiana Polis, IN, 5Sorbonne Université - APHP, Department of Rheumatology, Hôpital Pitié-Salpêtrière, Inserm UMRS 1136-5, PARIS, France, Paris, France

Meeting: ACR Convergence 2025

Keywords: autoimmune diseases, Disease-Modifying Antirheumatic Drugs (Dmards), race/ethnicity, Response Criteria, rheumatoid arthritis

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Session Information

Date: Monday, October 27, 2025

Title: (1347–1375) Rheumatoid Arthritis – Treatment Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: Here, we provide descriptive baseline characteristics and effectiveness outcomes of Baricitinib (BARI) and other ts/bDMARDs at 24-month (24M) in both European (EU) and non-European regions (OEU) regions, in addition to the effectiveness of BARI in EU countries at 36M, from the RA-BE-REAL study.

Methods: Patients (N&#3f1322) with rheumatoid arthritis (RA) from five EU countries (France, Germany, Italy, Spain, and UK) and three OEU countries (Australia, Canada, and Saudi Arabia) initiated BARI 2 mg or 4 mg (Cohort A) or any other targeted synthetic (ts) or biologic (b) disease-modifying antirheumatic drugs (DMARDs)(Cohort B) as per label requirements for the first time. Response rates for remission (REM) and low disease activity (LDA) were determined by the Clinical Disease Activity Index (CDAI), and patient’s assessment of pain using the 100 mm pain visual analog scale (VAS).

Results: A summary of patient characteristics identified higher baseline disease activity in OEU countries however, improvements in disease activity and pain were observed in both regions at 24M, Table 1.Effectiveness results at 24M within the EU and OEU subgroups mirrored the overall effectiveness data. The overall CDAI mean CFB at 24M was -13.3 (12.63) in the EU and -21.2 (17.19) in the OEU regions. The mean CFB in pain VAS was -20.6 (30.36) and -21.9 (28.97) in EU and OEU regions, respectively. Most patients within the EU and OEU subgroups achieved CDAI REM or LDA by 24M (EU: 68.3% Cohort A [23.6% REM, 44.7% LDA], 61.4% Cohort B [23.1% REM, 38.3% LDA]; OEU: 70.8% Cohort A [27.7% REM, 43.1% LDA], 65.4% Cohort B [24.4% REM, 41.0% LDA]), with results numerically favoring BARI. Patients treated with BARI in the EU subgroup were followed up for 36M, and improvements in disease activity and pain were maintained from baseline, Table 2.

Conclusion: Baseline clinical characteristics indicated that OEU patients exhibited higher disease activity, with similar improvements observed in EU and OEU patients treated with BARI. Effectiveness outcomes within EU and OEU subgroups reflected overall results, with results numerically favoring BARI. Effectiveness outcomes in the EU population of patients treated with BARI demonstrated a sustained response over 36M.

Supporting image 1

Supporting image 2


Disclosures: R. Alten: Abbvie, 6, Abbvie, BMS, Celltrion, Chugai, Galapagos, Janssen, Eli Lilly and Company, Novartis, Pfizer, Roche, UCB, and Viatris, 2, BMS, 6, Celltrion, 6, Chugai, 6, Eli Lilly and Company, 6, Janssen, 6, Novartis, 6, Pfizer, 6, Roche, 6, UCB, 6, Viatris, 6; G. Burmester: Celltrion, 6, Chugai, 6, Fresenius, 6, Gedeon Richter, 6, Sanofi, 6; M. Matucci-Cerinic: None; J. Gerwien: Eli Lilly and Company, 3, 11; W. Fakhouri: Eli Lilly and Company, 3, 11; S. Ogwu: Eli Lilly and Company, 3, 6; E. Haladyj: Eli Lilly and Company, 3, 6; I. De La Torre: Eli Lilly and Company, 3, 11; B. Fautrel: AbbVie, 2, 5, Amgen, 2, Biogen, 2, BMS, 2, Celltrion, 2, Chugai, 2, Eli Lilly & Co., 2, 5, Fresenius Kabi, 2, Galapagos, 2, Janssen, 2, Medac, 2, MSD, 2, 5, Nordic Pharma, 2, Novartis, 2, OW KIN, 2, Pfizer, 2, 5, Roche, 2, Sandoz, 2, Sanofi-Genzyme, 2, SOBI, 2, UCB, 2, Viatris, 2; A. Fernandez: Eli Lilly and Company, 3, 11.

To cite this abstract in AMA style:

Alten R, Burmester G, Matucci-Cerinic M, Gerwien J, Fakhouri W, Ogwu S, Haladyj E, De La Torre I, Fautrel B, Fernandez A. Real World Evaluation on the Effectiveness of Baricitinib or Other Treatments in Patients With Rheumatoid Arthritis: Data from the European and Non-European Cohorts of the RA-BE-REAL Study [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/real-world-evaluation-on-the-effectiveness-of-baricitinib-or-other-treatments-in-patients-with-rheumatoid-arthritis-data-from-the-european-and-non-european-cohorts-of-the-ra-be-real-study/. Accessed .
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