Observational studyBMJ open gastroenterology2026
Outcomes of risankizumab use in adults with Crohn's disease in a real-world setting (ARISE-CD): a multicentre, retrospective cohort study.
Observational study in BMJ open gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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22 authors.
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Abstract
objectiveRisankizumab is an interleukin-23 p19 subunit inhibitor, which gained UK approval in May 2023 for the treatment of Crohn's disease. Our aim was to evaluate risankizumab use in a real-world Crohn's disease cohort across North West England.
methodsARISE-CD is a retrospective, multicentre cohort study of adults with Crohn's disease across nine hospitals in North West England between May 2024 and April 2025. The primary outcome was treatment persistence at 6 months. Secondary outcomes included steroid-free persistence; steroid-free clinical remission (Crohn's Disease Activity Index (CDAI) <150 or Harvey Bradshaw Index (HBI) <5), biochemical remission (C-reactive protein (CRP) ≤5 mg/L and faecal calprotectin ≤250 µg/g) and reporting of adverse events. The cohort was also stratified by prior ustekinumab exposure.
results131 patients were included. All patients started risankizumab at least 6 months prior to data collection, with a median of 41 weeks (34-52) follow-up and a median of 2 (1-3) prior advanced therapies. 90% had exposure to prior anti-tumour necrosis factor therapy and 56% had been exposed to ustekinumab therapy. 6-month treatment persistence was 91% and 6-month steroid-free persistence was 84%. There was no difference in treatment persistence stratified by prior ustekinumab exposure. At 6 months, 14 out of 21 (67%) patients were in steroid-free clinical remission, and 15 out of 40 (38%) patients were in biochemical remission. In patients with paired results at baseline and 6 months, there was a significant reduction in median CRP (6 mg/L vs 4 mg/L, p=0.002) and median faecal calprotectin (201 µg/g vs 141 µg/g, p=0.001) at week 24. Prior ustekinumab exposure did not impact rates of steroid-free clinical remission or biochemical remission. No new safety signals were noted.
conclusionRisankizumab was effective in a multicentre, real-world cohort of patients with Crohn's disease, both with and without prior ustekinumab exposure. No new safety signals were noted.
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