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Introduction <p>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.</p> Methods <p>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&#xa0;months.</p> Results <p>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&#xa0;months, DAS28-CRP remission was observed in 65 (36.1%) patients, and remission or low disease activity in 98 (54.4%). At 12&#xa0;months, DAS28-CRP remission was observed in 64 (50.0%) patients, and remission or low disease activity in 81 (63.2%).</p> Conclusions <p>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.</p>

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

  • 期刊论文

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  • 发表日期：

    2025年12月4日

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  • 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

摘要

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.