Prospective real-world experience with risankizumab in difficult-to-treat Crohn's disease: results from the Dutch Initiative on Crohn and Colitis Registry

Loriane M M Verleye; Marieke J Pierik; Annemarie C de Vries; Fiona D M van Schaik; Andrea E van der Meulen-de Jong; Willemijn A van Dop; Mark Löwenberg; Marijn C Visschedijk; Myrthe R Naber; Dianne G Bouwknegt; Tessa E H Römkens; Alexander G L Bodelier; Philip W Voorneveld; Bas Oldenburg; Lauranne A A P Derikx; Marjolijn Duijvestein; Zlatan Mujagić; Dutch Initiative on Crohn and Colitis (ICC)

doi:10.1093/ibd/izag045

Prospective real-world experience with risankizumab in difficult-to-treat Crohn's disease: results from the Dutch Initiative on Crohn and Colitis Registry

Inflamm Bowel Dis. 2026 Apr 4:izag045. doi: 10.1093/ibd/izag045. Online ahead of print.

Authors

Loriane M M Verleye^{1

2}, Marieke J Pierik^{1

2}, Annemarie C de Vries³, Fiona D M van Schaik⁴, Andrea E van der Meulen-de Jong⁵, Willemijn A van Dop⁶, Mark Löwenberg⁷, Marijn C Visschedijk⁸, Myrthe R Naber⁴, Dianne G Bouwknegt⁸, Tessa E H Römkens⁹, Alexander G L Bodelier¹⁰, Philip W Voorneveld⁵, Bas Oldenburg⁴, Lauranne A A P Derikx³, Marjolijn Duijvestein⁶, Zlatan Mujagić^{1

2}; Dutch Initiative on Crohn and Colitis (ICC)

Collaborators

Dutch Initiative on Crohn and Colitis (ICC):
Ingrid Willemen-Boemaars, Safioen Nabibaks, Rachel L West, Sandra Cosijns, Loes H C Nissen, Bindia Jharap, Miranda Bouwens, Steven Jeuring, Ilse Sour, Kyra Hermans, Malena Schlotter, Martine van Workum, Marthe Verwey, Anne Meyboom, Jael Smid, Herma H Fidder, Nynke A Boontje, Vince Biemans, Tessa Straatmijer

Affiliations

¹ Department of Gastroenterology and Hepatology, Maastricht UMC+, 6229 HX Maastricht, the Netherlands.
² NUTRIM Institute for Nutrition and Translational Research in Metabolism, Maastricht University, 6229 ER Maastricht, the Netherlands.
³ Department of Gastroenterology and Hepatology, Erasmus University Medical Center, 3015 GD Rotterdam, the Netherlands.
⁴ Department of Gastroenterology and Hepatology, University Medical Center Utrecht, 3584 CX Utrecht, the Netherlands.
⁵ Department of Gastroenterology and Hepatology, Leiden University Medical Center, 2333 ZA Leiden, the Netherlands.
⁶ Department of Gastroenterology and Hepatology, Radboudumc, 6525 GA Nijmegen, the Netherlands.
⁷ Department of Gastroenterology and Hepatology, Amsterdam UMC, 1100 DD Amsterdam, the Netherlands.
⁸ Department of Gastroenterology and Hepatology, University Medical Center Groningen, 9713 GZ Groningen, the Netherlands.
⁹ Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 5223 GW 's-Hertogenbosch, the Netherlands.
¹⁰ Department of Gastroenterology and Hepatology, Amphia Hospital, 4818 CK Breda, the Netherlands.

PMID: 41934660
DOI: 10.1093/ibd/izag045

Abstract

Background: Risankizumab, a monoclonal antibody targeting interleukin-23, is approved for the treatment of Crohn's disease (CD). Real-world evidence on its effectiveness remains limited. We assessed 1-year effectiveness and safety of risankizumab in a prospective cohort of patients with CD, emphasizing difficult-to-treat disease.

Methods: Data were retrieved from the Dutch Initiative on Crohn and Colitis Registry. At baseline and at weeks 12, 24, and 52, clinical remission (Harvey-Bradshaw Index ≤4), biochemical remission (fecal calprotectin ≤250 µg/g and C-reactive protein levels ≤5 mg/L), systemic corticosteroids use, and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission (CSFCR) at week 24. Difficult-to-treat disease was defined as the failure of advanced therapies with at least 2 different mechanisms of action.

Results: In total, 151 patients initiated risankizumab before August 1, 2025; 136 (90.1%) of 151 patients had difficult-to-treat disease. At baseline, 90 (59.6%) patients had Harvey-Bradshaw Index >4. Of those, at week 24, 31 (50%) of 62 patients were in CSFCR; this rate was 53.3% when including all patients. Analysis including only patients with difficult-to-treat disease revealed that 51.8% of these patients were in CSFCR at week 24. Twenty-two (14.6%) patients discontinued treatment after a median of 183.5 days (Q1-Q3: 90.0-295.2 days), most following nonresponse. Regarding adverse events, 35.3 possibly and 16.6 probably risankizumab-related events per 100 person-years were reported.

Conclusion: In this prospective multicenter study, risankizumab demonstrated favorable effectiveness and safety profile in patients with CD, including those with difficult-to-treat disease, bowel surgery, and stoma. These findings support the use of risankizumab in patients with difficult-to-treat disease.

Keywords: difficult-to-treat disease; pharmacoepidemiology; real-world population.

Plain language summary

This prospective multicenter study shows that risankizumab is effective at inducing and maintaining corticosteroid-free clinical remission in patients with Crohn’s disease, including patients with difficult-to-treat disease. These findings are of significant interest to the scientific and clinical community.

Grants and funding

Dutch ICC