Real-World Effectiveness of Baricitinib in Rheumatoid Arthritis: Significant Reduction of Disease Activity Independent of Age in a Multicentre Retrospective Cohort Study

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Objective: To evaluate the real-world effectiveness of baricitinib (BARI) in rheumatoid arthritis (RA), compare outcomes in patients Methods: Retrospective multicentre cohort (n=423). Baseline variables included age, sex, disease duration, and comorbidities. DAS28-ESR was recorded at baseline, 6 and 12 months; remission was defined as DAS28-ESR Results: Median age was 60 years (IQR 50.5–69.5); 79% were female; median disease duration 76 months (IQR 31–157). Compared with patients <65, those ≥65 had longer disease duration (94 vs 65 months; p<0.05) and more diabetes (16% vs 5%), dyslipidaemia (47% vs 19%), and hypertension (62% vs 33%) (all p<0.05). Median DAS28-ESR fell from 5.42 (IQR 4.84–6.06) at baseline to 3.71 (2.83–4.59) at 6 months and 3.29 (2.42–4.19) at 12 months (global repeated-measures test significant). Remission+LDA was achieved by 135/421 (32.1%) at 6 months and 182/423 (43.0%) at 12 months; remission alone increased from 65/421 (15.4%) to 117/423 (27.7%). Age ≥65 was not associated with response (6 months: OR 0.71, 95% CI 0.44–1.14, p=0.16; 12 months: OR 0.83, 95% CI 0.55–1.24, p=0.37). ACPA positivity independently predicted remission/LDA (6 months: OR 2.32, 95% CI 1.43–3.77, p<0.05; 12 months: OR 1.71, 95% CI 1.12–2.59, p<0.05). Prior JAK inhibitor exposure was not associated with reduced response. Results were consistent in a per-protocol sensitivity analysis. Conclusion: In this large multicentre real-world cohort, BARI significantly reduced disease activity over 12 months, with comparable effectiveness across age groups. ACPA positivity emerged as an independent predictor of achieving remission/LDA, supporting its potential role in treatment stratification. Cite this article as: Lini D, Colina M, Andracco R, Ometto F, Ravagnani V, Lo Gullo A, Parisi S, Farina A, Del Medico P, Paroli M, Addimanda O, Bezzi A, Lumetti F, Molica-Colella AB, Murgia D, Larosa M, Ianniello A, Bravi E, Priora M, Scolieri P, Volpe A, Girelli F, Visalli E, Ariani A, Celletti E, Raffeiner B, Franchina V, Caccavale R, Serale F, Nucera V, Giampietro C, Bixio R, Rovera G, Fiorenza A, Ditto MC, Platè I, Mascella F, Di Donato E, Giuditta A, Santilli D, Mansueto N, Smerilli G, Ferrero G, Gabriele A, Colella FM, Amato G, De Lucia F, Dal Bosco Y, Foti R, Bernardi S, Di Penta M, Sabatini E, Cipollone F, Sandri G, Foti R, Bianchi G, Focherini MC, Bruzzese V, Lucchini G, Arrigoni E, Vitetta R, Camellino D, Marchetta A, Fusaro E, Reta M, Giuggioli D, Becciolini A. Real-World Effectiveness of Baricitinib in Rheumatoid Arthritis: Significant Reduction of Disease Activity Independent of Age in a Multicentre Retrospective Cohort Study. Mediterr J Rheumatol 2026;37(2):336-346. Article Submitted: 11 May 2025; Revised Form: 25 Aug 2025; Article Accepted: 13 Sep 2025; Available Online: 21 Apr 2026 https://doi.org/10.31138/mjr.110525.ain This work is licensed under a Creative Commons Attribution 4.0 International License. ©2026 The Author(s).

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