ntroduction: The efficacy and safety of fil- gotinib (FIL) for the treatment of patients with rheumatoid arthritis (RA) have been evaluated in a number of randomized controlled trials. How- ever, there is a scarcity of real-world studies eval- uating 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 rheuma- tology 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.esults: We enrolled 204 patients (80% female). The DRR of FIL was 90.2% (95% con- fidence 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 fac- tor. Effectiveness was evaluated as DAS28-CRP response. At 6 months, DAS28-CRP remission was observed in 65 (36.1%) patients, and remis- sion 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 dis- ease activity in 81 (63.2%).
Filgotinib Effectiveness in Rheumatoid Arthritis: Observational Analysis of a Large Multicenter Cohort / Celletti, Eleonora; Di Penta, Myriam; Ariani, Alarico; Parisi, Simone; Andracco, Romina; Raffeiner, Bernd; Ianniello, Aurora; Lo Gullo, Alberto; Biagio Molica Colella, Aldo; Priora, Marta; Paroli, Marino; Lumetti, Federica; Ravagnani, Viviana; Girelli, Francesco; Vitetta, Rosetta; Volpe, Alessandro; Scolieri, Palma; Bezzi, Alessandra; Ometto, Francesca; Visalli, Elisa; Farina, Antonella; Del Medico, Patrizia; Bravi, Elena; Colina, Matteo; Larosa, Maddalena; Serale, Francesca; Franchina, Veronica; Molica Colella, Francesco; Ferrero, Giulio; Sandri, Gilda; Addimanda, Olga; Reta, Massimo; Mascella, Fabio; Cristina Focherini, Maria; Fiorenza, Alessia; Rovera, Guido; Giampietro, Cecilia; Bernardi, Simone; Mansueto, Natalia; Camellino, Dario; Caccavale, Rosalba; Nucera, Valeria; Sabatini, Emanuela; Del Biondo, Pietro; Chiara Ditto, Maria; Platè, Ilaria; Adorni, Giuditta; Di Donato, Eleonora; Santilli, Daniele; Lucchini, Gianluca; Amato, Giorgio; De Lucia, Francesco; Dal Bosco, Ylenia; Foti, Roberta; Smerilli, Gianluca; Bianchi, Gerolamo; Foti, Rosario; Arrigoni, Eugenio; Marchetta, Antonio; Bixio, Riccardo; Bruzzese, Vincenzo; Fusaro, Enrico; Giuggioli, Dilia; Salvarani, Carlo; Cipollone, Francesco; Becciolini, Andrea. - In: RHEUMATOLOGY AND THERAPY. - ISSN 2198-6576. - 13:1(2026), pp. 179-193. [10.1007/s40744-025-00805-2]
Filgotinib Effectiveness in Rheumatoid Arthritis: Observational Analysis of a Large Multicenter Cohort
Federica Lumetti;Gilda Sandri;Dilia Giuggioli;Carlo Salvarani;
2026
Abstract
ntroduction: The efficacy and safety of fil- gotinib (FIL) for the treatment of patients with rheumatoid arthritis (RA) have been evaluated in a number of randomized controlled trials. How- ever, there is a scarcity of real-world studies eval- uating 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 rheuma- tology 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.esults: We enrolled 204 patients (80% female). The DRR of FIL was 90.2% (95% con- fidence 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 fac- tor. Effectiveness was evaluated as DAS28-CRP response. At 6 months, DAS28-CRP remission was observed in 65 (36.1%) patients, and remis- sion 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 dis- ease activity in 81 (63.2%).
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