ArticleInflammatory bowel diseases2026
Prospective real-world experience with risankizumab in difficult-to-treat Crohn's disease: results from the Dutch Initiative on Crohn and Colitis Registry.
Article in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Acceptability and tolerability of risankizumab maintenance therapy administered via on-body injector in patients with Crohn's disease: Results of the ACCEPT-OBI study.Therapeutic advances in gastroenterology · 2026Article
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18 authors.
Funding
Abstract
backgroundRisankizumab, 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.
methodsData 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.
resultsIn 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.
conclusionIn 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.
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