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

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 well-tolerated.