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

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 6 months. Our secondary endpoints were steroid-free clinical remission (Harvey-Bradshaw index <5), C-reactive protein (CRP) remission (CRP ≤5 mg) and faecal calprotectin (FCAL) remission (FCAL <250 µg/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.

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Journal
Frontline Gastroenterology
Published
2026-01-06
DOI
https://doi.org/10.1136/flgastro-2025-103449
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
0.00

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article

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

John Paul Seenan, F Cummings, Nathan Constantine‐Cooke, Umair Akbani et al.
Frontline Gastroenterology
Inflammatory Bowel Disease
article

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

John Paul Seenan, F Cummings, Nathan Constantine‐Cooke, Umair Akbani, Zoheb Anwar-Hashim, EL Johnston, Fakhirah Badrulhisham, Rishi Goel, Ajay Verma, S Sebastian, Michael Colwill, Magdalini Manti, Lucy Hicks, Sarah Hancox, Vikram Mohanan, Peter Miles Irving, Chandni Radia, Sean Michael Morris, Richard Pollok, Philip Harvey, E Brownson, Gareth Parkes, Alexander T. Elford, Andrew King, Sarah Faloon, Benjamin Zaré, Lovesh Dyall, Jie Han Yeo, Benjamin Disney, Rachel Cooney, Christian P. Selinger, Sara McCartney, Charlie W. Lees, Taha Mahmood, David Young, Mithun Thomas, Krishna Shah, MA Samaan, Melissa F Hale, Naila Arebi, Jimmy K Limdi, Nikolas Plevris, James Henry Arthur Hassall, Aboalgasim Mohammed, Tariq Ahmad, Jennie Clough, The UK experience of Risankizumab in Crohn’s disease, Hannah Morgan, Robert J Mulligan, Alexandra Kent
article en

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 6 months. Our secondary endpoints were steroid-free clinical remission (Harvey-Bradshaw index <5), C-reactive protein (CRP) remission (CRP ≤5 mg) and faecal calprotectin (FCAL) remission (FCAL <250 µg/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.

Frontline Gastroenterology
University Hospitals Birmingham NHS Foundation Trust (GB), University College London Hospitals NHS Foundation Trust (GB), The University of Melbourne (AU), University of Hull (GB), Guy's and St Thomas' NHS Foundation Trust (GB), Barts Health NHS Trust (GB), Leeds Teaching Hospitals NHS Trust (GB), Royal Devon & Exeter NHS Foundation Trust (GB), Manchester Academic Health Science Centre (GB), Chelsea and Westminster Hospital NHS Foundation Trust (GB), Western General Hospital (GB), NHS Greater Glasgow and Clyde (GB), Glasgow Royal Infirmary (GB), St George’s University Hospitals NHS Foundation Trust (GB), Kettering General Hospital (GB), Newcastle upon Tyne Hospitals NHS Foundation Trust (GB), Edinburgh Cancer Research (GB), University Hospital Southampton NHS Foundation Trust (GB), University of Manchester (GB), Northern Health and Social Care Trust (GB), Sheffield Teaching Hospitals NHS Foundation Trust (GB), Coventry and Warwickshire Partnership NHS Trust (GB), King's College Hospital NHS Foundation Trust (GB), Kingston Hospital (GB), The Royal Wolverhampton NHS Trust (GB), Wolverhampton Hospital (GB), Melbourne Health (AU), Institute of Genetics and Cancer (GB), Mid Yorkshire Hospitals NHS Trust (GB), St Mark's Hospital (GB), University College London (GB), Imperial College London (GB), Hull York Medical School (GB), Manchester University (US), University of Edinburgh (GB)
Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Sanofi, Celltrion, Dr. Falk Pharma, Samsung
Openalex Percentile: Top 95%
Inflammatory Bowel Disease
DOIOpen Access PDFOpenAlex
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