TY - JOUR
T1 - Prospective real-world experience with risankizumab in difficult-to-treat Crohn's disease
T2 - results from the Dutch Initiative on Crohn and Colitis Registry
AU - Verleye, Loriane M M
AU - Pierik, Marieke J
AU - de Vries, Annemarie C
AU - van Schaik, Fiona D M
AU - van der Meulen-de Jong, Andrea E
AU - van Dop, Willemijn A
AU - Löwenberg, Mark
AU - Visschedijk, Marijn C
AU - Naber, Myrthe R
AU - Bouwknegt, Dianne G
AU - Römkens, Tessa E H
AU - Bodelier, Alexander G L
AU - Voorneveld, Philip W
AU - Oldenburg, Bas
AU - Derikx, Lauranne A A P
AU - Duijvestein, Marjolijn
AU - Mujagić, Zlatan
N1 - Publisher Copyright:
© The Author(s) 2026. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
PY - 2026/8
Y1 - 2026/8
N2 - 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.
AB - 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.
KW - difficult-to-treat disease
KW - pharmacoepidemiology
KW - real-world population
UR - https://www.scopus.com/pages/publications/105045849186
U2 - 10.1093/ibd/izag045
DO - 10.1093/ibd/izag045
M3 - Article
C2 - 41934660
SN - 1078-0998
VL - 32
SP - 1460
EP - 1470
JO - Inflammatory bowel diseases
JF - Inflammatory bowel diseases
IS - 8
ER -