Real-world Cohort Study on the Effectiveness and Safety of Filgotinib Use in Ulcerative Colitis Crohns Colitis. 2025 Jan 11;19(1):jjad187.doi: 10.1093/ecco-jcc/jjad187. Beatriz Gros 1 2 3, Mairi Goodall 4, Nik Plevris 1, Nathan Constantine-Cooke 5 6, Alexander T Elford 1 7, Claire O'Hare 1 8, Colin Noble 1, Gareth-Rhys Jones 1 9, Ian D Arnott 1, Charlie W Lees 1 6 |
Author information 1Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK. 2Department of Gastroenterology and Hepatology, Reina Sofía University Hospital, Córdoba, Spain. 3Maimonides Institute of Biomedical Research [IMIBIC], Córdoba, Spain. 4Medical School, University of Glasgow, Glasgow, UK. 5MRC Human Genetics Unit, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK. 6Centre for Genomics and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK. 7Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia. 8Edinburgh Pharmacy Unit, Western General Hospital, Edinburgh, UK. 9Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Abstract Background: Filgotinib is a small molecule with preferential inhibition of Janus kinase type 1, approved for the treatment of ulcerative colitis in Scotland in May 2022. We present the first real-world experience on its use in clinical practice. Methods: In this retrospective, observational, cohort study we assessed patients with active ulcerative colitis who received filgotinib in NHS Lothian, Scotland. Baseline demographic, phenotype, and follow-up data were collected via review of electronic medical records. Results: We included 91 patients with median treatment duration of 39 weeks (interquartile range [IQR] 23-49). Among the cohort, 67% [61/91] were biologic- and small molecule-naïve, and 20.9% [19/91] had failed one and 12.1% [11/91] two or more classes of advanced therapy. Of the biologic- and small molecule-naïve patients, 18% [11/61] were also thiopurine-naïve. Clinical remission [partial Mayo score <2] was achieved in 71.9% [41/57] and 76.4% [42/55] of patients at Weeks 12 and 24 respectively. Biochemical remission [C reactive protein ≤5 mg/L] was achieved in 87.3% [62/71] at Week 12 and 88.9% [40/45] at Week 24. Faecal biomarker [calprotectin <250 µg/g] remission was achieved in 82.8% [48/58] at Week 12 and 79.5% [35/44] at Week 24. At the end of follow-up, median 42 weeks [IQR 27-50], 82.4% [75/91] of patients remained on filgotinib. Severe adverse events leading to drug discontinuation occurred in 2.2% [2/91] and there were 8.8% [8/91] moderate adverse events that required temporary discontinuation. Conclusion: These are the first reported data on the real-world efficacy and safety of filgotinib in ulcerative colitis. Our findings demonstrate that filgotinib is an effective and low-risk treatment option for these patients. |
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