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January 23, 2026

P0538Efficacy and safety of risankizumab in Inflammatory Bowel Disease: real-world experience from the Canary Islands

Puntos clave

This study aims to evaluate the effectiveness, safety, and treatment persistence of risankizumab in patients with Crohn’s disease in real-world clinical practice.
Prospective multicenter observational design
Inclusion of consecutive Crohn’s disease patients
Data collection on disease characteristics and biomarkers
Assessment of clinical activity using the Harvey–Bradshaw Index
Evaluation of biochemical remission criteria (CRP and FC levels)
34 patients with Crohn's disease included, predominantly with ileocolonic location
Significant improvement in clinical activity at week 4 and 6 months
Increase in biochemical remission from 21.2% at baseline to 42.8% at 6 months
94% treatment persistence observed at 6 months with minimal adverse events

Resumen

Abstract Background Risankizumab is an anti–IL-23 monoclonal antibody that has demonstrated efficacy in moderate-to-severe active Crohn’s disease (CD) in clinical trials. However, real-world evidence, particularly from prospective Spanish cohorts, remains limited. The aim of this study was to assess the effectiveness, safety, and treatment persistence of risankizumab in patients with CD in routine clinical practice. Methods This was a prospective multicenter observational study (RISANCAN registry) including consecutive CD patients treated with risankizumab according to clinical judgment in four hospitals in the Canary Islands. Demographic data, disease characteristics, previous treatments, clinical activity (Harvey–Bradshaw Index, HBI), biomarkers (C-reactive protein, CRP; fecal calprotectin, FC), and the patient’s global subjective assessment (GSA) were collected. Biochemical remission data (CRP 5 mg/L and FC 150 μg/g) was evaluated. Predictive factors for response at week 4, at week 12 and month 6, the occurrence of adverse events, and drug survival were also analyzed. Results Thirty-four CD patients were included (18 women, 53%), with a mean age of 47. 8 ± 15. 6 years. Disease location was ileocolonic (L3) in 18 patients (53%), with an inflammatory phenotype (B1) in 17 patients (50%) and a penetrating phenotype (B3) in 5 patients (14. 7%). Baseline HBI was 3. 7 ± 3, and mean CRP was 4. 37 ± 1. 2 mg/L. At baseline, FC levels were 409 ± 150 μg/g, with 75. 8% of patients having FC 150 μg/g. A progressive improvement was observed at week 4 (52. 9%, p = 0. 042) and at 6 months (38. 2%, p = 0. 005). Similarly, at baseline, 72. 7% of patients reported active disease on GSA, decreasing to 35. 3% at week 4 (p = 0. 005) and 23. 5% at 6 months (p 0. 001). Regarding biochemical remission, baseline remission was 21. 2%, increasing significantly at week 4 (25. 7%, p = 0. 043) and at 6 months (42. 8%, p = 0. 038). At 6 months of follow-up, no independent predictive factors of clinical response were identified. Treatment persistence at 6 months was 94%, with two patients discontinuing due to lack of response. No significant adverse events were reported. Conclusion The RISANCAN registry provides prospective real-world data on short- and mid-term efficacy of risankizumab in CD patients in the Canary Islands, showing a favorable safety and durability profile in our setting. These findings contribute to optimizing therapeutic strategies and candidate selection in clinical practice. References: Gisbert JP. , Chaparro M. Predictors of Primary Response to Biologic Treatment Anti-TNF, Vedolizumab, and Ustekinumab in Patients with Inflammatory Bowel Disease: From Basic Science to Clinical Practice. J Crohns Colitis 2020;14 (5). Doi: 10. 1093/ecco-jcc/jjz195. Gisbert JP. , Chaparro M. Acute severe ulcerative colitis: State of the art treatment. Best Pract Res Clin Gastroenterol 2018;32–33: 59–69. Doi: 10. 1016/j. bpg. 2018. 05. 007. Herrera-deGuise C, Serra-Ruiz X, Lastiri E, et al. JAK inhibitors: a new dawn for oral therapies in inflammatory bowel diseases. Front Med (Lausanne) 2023;10: 1089099. Ma C, Jairath V, vande Casteele N. Pharmacology, efficacy and safety of JAK inhibitors in Crohn’s disease. Best Pract Res Clin Gastroenterol. 2019. doi: 10. 1016/j. bpg. 2019. 03. 002. Gisbert JP, Chaparro M. Acute severe ulcerative colitis: State of the art treatment. Best Pract Res Clin Gastroenterol. 2018;32–33: 59–69. doi: 10. 1016/j. bpg. 2018. 05. 007. Geert D’Haens, Remo Panaccione, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399 (10340): 2015-2030. doi: 10. 1016/S0140-6736 (22) 00467-6. Marc Ferrante, Remo Panaccione, 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. 2022 May 28;399 (10340): 2031-2046. doi: 10. 1016/S0140-6736 (22) 00466-4. Conflict of interest: Dr. Alonso, Inmaculada: No conflict of interest Martín González, Marta: No conflict of interest Ashok Bhagchandani, Rashika: No conflict of interest Morant Domínguez, Andrea María: No conflict of interest Marquez Rodriguez, Juan Alberto: I have provided scientific advice/participated in medical meetings for Kern and Takeda. I am receiving a gratification for this presentation. Fernandez, Edgar: No Kolle, Lilyan: No conflict of interest Medina Chico, Jose Sergio: No conflict of interest Reygosa, María Cristina: No conflict of interest Ramos Lopez, Laura: L. R. has acted as a speaker or received funding for training from MSD, Abbvie, Adacyte, Takeda, Pfizer, Janssen, and Ferring. Carrillo Palau, Marta: No conflict of interest

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Cite This Study

Alonso et al. (Thu,) studied this question.

synapsesocial.com/papers/69730f18c8125b09b0d1ed6e https://doi.org/https://doi.org/10.1093/ecco-jcc/jjaf231.719

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