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Lookup NU author(s): Dr Robert MulliganORCiD, Dr Andrew King
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group. Objective: Risankizumab is an interleukin-23 p19 subunit inhibitor which received approval for Crohn’s disease (CD) by UK licensing authorities in May 2023. Our aim was to evaluate the real-world outcomes of risankizumab in the UK. Design We conducted a retrospective, multicentre, cohort study of patients with CD treated with risankizumab across 25 health boards in the UK between 1 January 2021 and 1 November 2024. Our primary outcome was treatment persistence at 6months. Our secondary endpoints were steroid-free clinical remission (Harvey-Bradshaw index <5), C-reactive protein (CRP) remission (CRP ≤5mg) and faecal calprotectin (FCAL) remission (FCAL <250µg/g). Results: We included 763 patients with a median follow-up time of 27 weeks (IQR 18–41 weeks) with a total of 432 and 110 patients having 6-month and 12-month data available. The median number of advanced therapy exposures was 3 (2–4), with 92% (704/763) having failed anti-tumour necrosis factor therapy and 72% (548/763) having failed ustekinumab. Treatment persistence at 6 and 12 months was 95.4% and 89.2%,respectively. Unadjusted persistence rates for ustekinumab-naive versus ustekinumab-exposed patients were 92.7% vs 95.3% and 89.0% vs 74.2% at 6 and 12 months, respectively (p=0.62). Rates of clinical, CRP and FCAL remission were 52% (123/236), 53% (169/319) and 44% (69/156) at 6 months. Rates of clinical remission for ustekinumab naive versus exposed were 57% (29/51) vs 51% (94/185) (p=0.54) 6 months. Adverse events occurred in 17% (n=127) of the cohort, of which 12% (n=92) were serious. Conclusion: Risankizumab was effective in a large, real-world, medically refractory CD cohort with excellent persistence and good clinical and biochemical remission rates.
Author(s): Elford AT, Constantine-Cooke N, Shah K, Faloon SC, Manti M, Zare B, Colwill M, Yeo JH, Akbani U, Morgan H, Mulligan RJ, Radia C, Young D, Badrulhisham F, Morris S, Anwar-Hashim Z, Hassall JHA, Thomas M, Dyall L, Clough J, Mahmood T, Mohammed A, Mohanan V, Brownson E, Hancox S, Disney B, Verma AM, Seenan JP, Johnston E, Goel R, Hicks LC, Sebastian S, Hale M, Harvey P, Cooney R, Ahmad T, Cummings F, Kent A, King A, Limdi JK, Selinger C, McCartney S, Pollok R, Irving PM, Samaan MA, Arebi N, Parkes G, Lees CW, Plevris N, Hall R, Harrow P, Roberts C, Niazi N, Dhar A, Rudling R, Gaya DR
Publication type: Article
Publication status: Published
Journal: Frontline Gastroenterology
Year: 2026
Pages: Epub ahead of print
Online publication date: 06/01/2026
Acceptance date: 26/12/2025
Date deposited: 24/06/2026
ISSN (print): 2041-4137
ISSN (electronic): 2041-4145
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/flgastro-2025-103449
DOI: 10.1136/flgastro-2025-103449
Data Access Statement: All data relevant to the study are included in the article or uploaded as supplementary information.
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