Filgotinib Effectiveness in Rheumatoid Arthritis: Observational Analysis of a Large Multicenter Cohort.

IF 3.1 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2026-02-01 Epub Date: 2025-12-04 DOI:10.1007/s40744-025-00805-2

Eleonora Celletti, Myriam Di Penta, Alarico Ariani, Simone Parisi, Romina Andracco, Bernd Raffeiner, Aurora Ianniello, Alberto Lo Gullo, Aldo Biagio Molica Colella, Marta Priora, Marino Paroli, Federica Lumetti, Viviana Ravagnani, Francesco Girelli, Rosetta Vitetta, Alessandro Volpe, Palma Scolieri, Alessandra Bezzi, Francesca Ometto, Elisa Visalli, Antonella Farina, Patrizia Del Medico, Elena Bravi, Matteo Colina, Maddalena Larosa, Francesca Serale, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero, Gilda Sandri, Olga Addimanda, Massimo Reta, Fabio Mascella, Maria Cristina Focherini, Alessia Fiorenza, Guido Rovera, Cecilia Giampietro, Simone Bernardi, Natalia Mansueto, Dario Camellino, Rosalba Caccavale, Valeria Nucera, Emanuela Sabatini, Pietro Del Biondo, Maria Chiara Ditto, Ilaria Platè, Giuditta Adorni, Eleonora Di Donato, Daniele Santilli, Gianluca Lucchini, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Gianluca Smerilli, Gerolamo Bianchi, Rosario Foti, Eugenio Arrigoni, Antonio Marchetta, Riccardo Bixio, Vincenzo Bruzzese, Enrico Fusaro, Dilia Giuggioli, Carlo Salvarani, Francesco Cipollone, Andrea Becciolini

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引用次数: 0

Abstract

Introduction: The efficacy and safety of filgotinib (FIL) for the treatment of patients with rheumatoid arthritis (RA) have been evaluated in a number of randomized controlled trials. However, there is a scarcity of real-world studies evaluating the effectiveness, persistence, tolerability, and safety of FIL in everyday clinical practice. This study aimed to assess the effectiveness and retention rate of FIL in a real-world cohort of patients with RA.

Methods: A multicenter retrospective cohort study of patients with RA treated with FIL was conducted in 27 Italian tertiary referral rheumatology centers. The drug retention rate (DRR) was estimated by the Kaplan-Meier method, while multivariate Cox regression was used to detect potential factors affecting drug survival and persistence in therapy. Disease activity score (DAS28-CRP) was assessed at baseline and after 6 and 12 months.

Results: We enrolled 204 patients (80% female). The DRR of FIL was 90.2% (95% confidence interval (CI) 86-94.6%), 75.1% (95% CI 68.5-82.4%), and 64.7% (95% CI 56.3-74.3%) at months 6, 12, and 18, respectively. The DRR was negatively associated with the line of treatment and the presence of rheumatoid factor. Effectiveness was evaluated as DAS28-CRP response. At 6 months, DAS28-CRP remission was observed in 65 (36.1%) patients, and remission or low disease activity in 98 (54.4%). At 12 months, DAS28-CRP remission was observed in 64 (50.0%) patients, and remission or low disease activity in 81 (63.2%).

Conclusions: This analysis of real-world patients with RA demonstrated the effectiveness of FIL with a good DAS28-CRP response and high DRR at follow-up.

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非戈替尼治疗类风湿性关节炎的有效性：一项大型多中心队列研究的观察性分析。

非戈替尼（FIL）治疗类风湿性关节炎（RA）的有效性和安全性已经在一些随机对照试验中得到了评价。然而，在日常临床实践中，评估FIL的有效性、持久性、耐受性和安全性的真实世界研究缺乏。本研究旨在评估FIL在现实世界RA患者队列中的有效性和保留率。方法：在意大利27个三级转诊风湿病中心对接受FIL治疗的RA患者进行多中心回顾性队列研究。采用Kaplan-Meier法估计药物保留率（DRR），并采用多因素Cox回归检测影响药物生存和持续治疗的潜在因素。在基线、6个月和12个月后评估疾病活动度评分（DAS28-CRP）。结果：我们入组204例患者（80%为女性）。在第6个月、第12个月和第18个月，FIL的DRR分别为90.2%（95%可信区间（CI） 86-94.6%）、75.1% （95% CI 68.5-82.4%）和64.7% （95% CI 56.3-74.3%）。DRR与治疗方式和类风湿因子的存在呈负相关。以DAS28-CRP反应评价疗效。6个月时，65例（36.1%）患者DAS28-CRP缓解，98例（54.4%）患者缓解或低疾病活动度。12个月时，64例（50.0%）患者DAS28-CRP缓解，81例（63.2%）患者缓解或疾病活动度低。结论：对现实世界RA患者的分析表明，FIL具有良好的DAS28-CRP反应和随访时的高DRR的有效性。

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies. 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