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Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres

Authors :
David Young
Sohail Rahmany
Deborah Taylor
Emma Davis
Michael Colwill
Sonia Kalyanji Mehta
Roisin Campbell
Karl Hazel
Karishma Sethi-Arora
Susan Ritchie
Ashley I Heinson
Helen Moyses
Keith Bodger
Emma Johnston
Lucy Hicks
Anjan Dhar
Jimmy Limdi
Rachel Cooney
John Paul Seenan
Kamal Patel
Alissa Walsh
Fraser Cummings
Source :
Drugs in Context, Iss 14, Pp 1-14 (2025)
Publication Year :
2025
Publisher :
BioExcel Publishing Ltd, 2025.

Abstract

Background: Filgotinib, an oral Janus kinase 1 preferential inhibitor, has been shown to be an effective treatment for ulcerative colitis (UC) in pre-registration studies. We aimed to describe the treatment population, effectiveness and safety of filgotinib in a real-world cohort of patients with UC. Methods: A retrospective observational cohort evaluation was conducted across nine UK inflammatory bowel disease centres. Baseline demographic and clinical data, clinical disease activity scores, endoscopic activity indices, and biomarkers (C-reactive protein and faecal calprotectin) were collected at baseline, at 8–12 weeks after initiation (post-induction) and during maintenance (the most recent review) where available. Effectiveness outcomes were assessed in patients with combined clinical disease activity and objective evidence of inflammation at filgotinib initiation. Results: Data were analysed for a total of 286 patients with a median follow-up time of 229 (IQR 113–324) days. The median age at filgotinib initiation was 38 (IQR 27–51) years, 64% were men and median disease duration was 5.1 (IQR 1.9–10.5) years; 56% had previous exposure to advanced therapies (biologics and small molecule) and 6% previously received tofacitinib. At the post-induction review, clinical response and remission were achieved in 65% and 51% of patients, respectively. There was a reduction in biomarkers and 78% of patients using corticosteroids at baseline were steroid-free. Persistence on filgotinib at 12 months was 66%. Adverse events were recorded in 30 patients with 8 patients discontinuing filgotinib as a result of an adverse event. Conclusions: In a large real-world cohort of patients with UC, filgotinib appears to be effective and welltolerated.

Details

Language :
English
ISSN :
17404398
Issue :
14
Database :
Directory of Open Access Journals
Journal :
Drugs in Context
Publication Type :
Academic Journal
Accession number :
edsdoj.b62f2f2c0f3242d18078cad330906ca2
Document Type :
article
Full Text :
https://doi.org/10.7573/dic.2024-11-1