Real-world effectiveness of risankizumab in Crohn's disease: a pan UK retrospective cohort study.

Elford A.T.; Constantine-Cooke N.; Shah K.; Faloon S.C.; Manti M.; Zare B.; Colwill M.; Yeo J.H.; Akbani U.; Morgan H.; Mulligan R.J.; Radia C.; Young D.; Badrulhisham F.; Morris S.; Anwar-Hashim Z.; Hassall J.H.A.; Thomas M.; Dyall L.; Clough J.; Mahmood T.; Mohammed A.; Mohanan V.; Brownson E.; Hancox S.; Disney B.; Verma A.M.; Seenan J.P.; Johnston E.; Goel R.; Hicks L.C.; Sebastian S.; Hale M.; Harvey P.; Cooney R.; Ahmad T.; Cummings F.; Kent A.; King A.; Limdi J.K.; Selinger C.; McCartney S.; Pollok R.; Irving P.M.; Samaan M.A.; Arebi N.; Parkes G.; Lees C.W.; Plevris N.; Hall R.; Harrow P.; Roberts C.; Niazi N.; Dhar A.; Rudling R.; Gaya D.R.

Real-world effectiveness of risankizumab in Crohn's disease: a pan UK retrospective cohort study.

All Authors

Elford A.T.

Constantine-Cooke N.

Shah K.

Faloon S.C.

Manti M.

Zare B.

Colwill M.

Yeo J.H.

Akbani U.

Morgan H.

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LTHT Author

Akbani, Umair
Selinger, Christian

LTHT Department

Doctors' Rotation
Abdominal Medicine & Surgery
Gastroenterology

Publication Date

2026

Item Type

Article In Press

Subject

CROHN DISEASE , GLUCOCORTICOIDS , ANTIBODIES, MONOCLONAL , UNITED KINGDOM , INFLAMMATORY BOWEL DISEASES , COLITIS , ANTINEOPLASTIC AGENTS

Abstract

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 <250microg/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.Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.