P0960 Risankizumab induces radiological healing in treatment-refractory small bowel Crohn’s disease
Authors: Shakweh E , Zare B , Ibarra A , Conde-Jimenez R , Yeo J H , Gerard P , Kok K B , Harrow P , Samaan M , Hart A 
Published: January 2025

Background

Small bowel (SB) Crohn’s disease (CD) is a heterogenous condition, ranging from short segments of inflammation in the terminal ileum, to multifocal inflammatory, stricturing or fistulising phenotypes. Up to 80% of patients with CD have SB involvement and symptoms can be debilitating and difficult to treat. Despite the evolving therapeutic armamentarium of CD therapies, efficacy in SB CD remains unclear as SB radiological outcome measures are not routinely reported in clinical trials. Risankizumab has demonstrated efficacy in CD and effectiveness in a real-world setting. We aim to measure radiological improvement in patients with SB CD initiated on risankizumab across four London tertiary centres.

Methods

We conducted a retrospective study of patients with SB CD initiated on risankizumab between May 2021 and November 2024. We collected all available radiological data (CT/MR/US) across different time points. The primary outcome measure was radiological improvement by week 36 (defined as documented improvement by the reporting radiologist). We analysed data for patients with baseline imaging demonstrating SB inflammation (within 6 months prior to starting risankizumab) and at least 1 interval scan within 36 weeks of risankizumab initiation.

Results

35 patients met the eligibility criteria, with 27 demonstrating radiologically active SB disease at baseline. 89% (31/35) of the full cohort and 93% (25/27) of those with active SB disease at baseline had ileocolonic disease. 22/27 (81%) had prior experience of ≥3 advanced therapies. 48% (13/27) had stricturing disease, 32% (9/27) had penetrating disease (9/27, 32%) and 86% (24/27) had prior luminal surgery.

Median duration of follow-up was 196 (IQR, 107) days post-induction. 48% (13/27) had radiological improvement of previously active SB CD, within a median 110 (IQR 71) days. Only 3 patients demonstrating improvement were receiving additional treatment at the time of their interval scan (1/13 on oral corticosteroids and 2/13 on exclusive enteral nutrition).

Separating responders chronologically at weeks 4, 8, 12, 20, 28, and 36, radiological improvement in those with baseline active disease was observed in 0/2 (0%), 4/5 (80%), 0/3 (0%), 5/9 (56%), 3/7 (43%), and 2/5 (40%) cases, respectively.

Conclusion

Risankizumab induces radiological healing in SB CD in a treatment-refractory cohort, with response rates as high as 50% by week 36. SB healing can be observed as early as 20 weeks into treatment.

References

1.Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1.

2.Ferrante, Marc et al. "Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial." Lancet (London, England) vol. 399,10340 (2022): 2031-2046. doi:10.1016/S0140-6736(22)00466-4.

3.Zare B, Gros B, Lal N, et alEffectiveness of risankizumab induction and maintenance therapy for refractory Crohn’s disease: a real-world experience from a pre-approval access programme and early access to medicines scheme. Frontline Gastroenterology 2024;15:499-506. doi: 0.1136/flgastro-2024-102809.

4.Fumery, Mathurin et al. "Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn’s disease: A GETAID multicentre cohort study." Alimentary pharmacology & therapeutics vol. 57,4 (2023): 426-434. doi:10.1111/apt.17358.

*Eathar Shakweh and Benjamin Zare have contributed equally to this work and are acknowledged as joint first authors.