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Observational Study
. 2025 Jan 11;19(1):jjad187.
doi: 10.1093/ecco-jcc/jjad187.

Real-world Cohort Study on the Effectiveness and Safety of Filgotinib Use in Ulcerative Colitis

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
Affiliations
Observational Study

Real-world Cohort Study on the Effectiveness and Safety of Filgotinib Use in Ulcerative Colitis

Beatriz Gros et al. J Crohns Colitis. .

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.

Keywords: Ulcerative colitis; filgotinib; inflammatory bowel disease; small molecule.

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Conflict of interest statement

BG has served as consultant to Galapagos and Abbvie and as speaker for Abbvie, Jansen, Takeda, Pfizer, and Galapagos. NP has served as a speaker for Janssen, Takeda and Pfizer. CL has acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Galapagos, Bristol Myers Squibb, B.I., Sandoz, Novartis, GSK, Gilead, ViforPharma, Dr Falk, Trellus Health, and Iterative Scopes; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Galapagos, MSD, Takeda, Shire, Ferring, Hospira, and Dr Falk. G-RJ has served as a speaker for Takeda, Janssen, Abbvie, Fresnius, and Ferring.

Figures

Figure 1
Figure 1
Clinical, biochemical, and faecal calprotectin biomarker remission at baseline, Week 12 and Week 24 from filgotinib initiation. CRP, C-reactive protein; FC, faecal calprotectin.
Figure 2
Figure 2
Kaplan–Meier curve for filgotinib persistence.
See this image and copyright information in PMC

References

    1. Web Scottish Filgotinib Approval . 2022. https://www.scottishmedicines.org.uk/medicines-advice/filgotinib-jyselec... Accessed July 26, 2023.
    1. Feagan BG, Danese S, Loftus EV, et al. . Filgotinib as induction and maintenance therapy for ulcerative colitis [SELECTION]: a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet 2021;397:2372–84. doi:10.1016/S0140-6736[21]00666-8 - DOI - PubMed
    1. Danese S, Ferrante M, Feagan BG, et al. . Rapid and sustained symptom relief in patients with ulcerative colitis treated with filgotinib: data from the phase 2b/3 SELECTION trial. Am J Gastroenterol 2023;118:138–47. doi:10.14309/ajg.0000000000001979 - DOI - PMC - PubMed
    1. Nyirenda MH, Nijjar JS, Frleta-Gilchrist M, et al. . JAK inhibitors disrupt T cell-induced proinflammatory macrophage activation. RMD open 2023;9:e002671–5. doi:10.1136/rmdopen-2022-002671 - DOI - PMC - PubMed
    1. Liu E, Aslam N, Nigam G, Limdi JK.. Tofacitinib and newer JAK inhibitors in inflammatory bowel disease—where we are and where we are going. Drugs in Context 2022;11:1–17. doi:10.7573/dic.2021-11-4 - DOI - PMC - PubMed

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