Real-World Effectiveness of Baricitinib in Rheumatoid Arthritis: Significant Reduction of Disease Activity Independent of Age in a Multicentre Retrospective Cohort Study.
Daniele Lini, Matteo Colina, Romina Andracco, Francesca Ometto, Viviana Ravagnani, Alberto Lo Gullo, Simone Parisi, Antonella Farina, Patrizia Del Medico, Marino Paroli, Olga Addimanda, Alessandra Bezzi, Federica Lumetti, Aldo Biagio Molica Colella, Davide Murgia, Maddalena Larosa, Aurora Ianniello, Elena Bravi, Marta Priora, Palma Scolieri, Alessandro Volpe, Francesco Girelli, Elisa Visalli, Alarico Ariani, Eleonora Celletti, Bernd Raffeiner, Veronica Franchina, Rosalba Caccavale, Francesca Serale, Valeria Nucera, Cecilia Giampietro, Riccardo Bixio, Guido Rovera, Alessia Fiorenza, Maria Chiara Ditto, Ilaria Platè, Fabio Mascella, Eleonora Di Donato, Adorni Giuditta, Daniele Santilli, Natalia Mansueto, Gianluca Smerilli, Giulio Ferrero, Amati Gabriele, Francesco Molica Colella, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Simone Bernardi, Myriam Di Penta, Emanuela Sabatini, Francesco Cipollone, Gilda Sandri, Rosario Foti, Gerolamo Bianchi, Maria Cristina Focherini, Vincenzo Bruzzese, Gianluca Lucchini, Eugenio Arrigoni, Rosetta Vitetta, Dario Camellino, Antonio Marchetta, Enrico Fusaro, Massimo Reta, Dilia Giuggioli, Andrea Becciolini
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引用次数: 0
Abstract
Objective: To evaluate the real-world effectiveness of baricitinib (BARI) in rheumatoid arthritis (RA), compare outcomes in patients <65 years versus ≥65 years, and identify predictors of DAS28-ESR remission/low disease activity (LDA) at 6 and 12 months.
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 <2.6 and LDA as ≤3.2. Predictors of remission/LDA were assessed with multivariable logistic regression, reporting odds ratios (ORs), 95% confidence intervals (CIs), and p-values.
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.