Outcomes of risankizumab use in adults with Crohn's disease in a real-world setting (ARISE-CD): a multicentre, retrospective cohort study.

OBJECTIVE

Risankizumab 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.

METHODS

ARISE-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.

RESULTS

131 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.

CONCLUSION

Risankizumab 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.