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4CPS-125 Treatment efficacy to risankizumab in Crohn’s disease patients with and without prior ustekinumab exposure

ejhpharm · 2026-03-18 · canonical JSON source

21 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Risankizumab (anti-IL23) and Ustekinumab (anti-IL12/23) are approved treatments for active Crohn’s Disease (CD). Given the increasing use of sequential biologic therapies in CD, evaluating the role of Risankizumab after Ustekinumab is clinically relevant.Aim and Objectives Describe baseline characteristics and assess the efficacy of Risankizumab in patients with active CD, including both anti-IL23-naïve individuals and those previously treated with Ustekinumab, in real-world clinical practice at a tertiary hospital.Material and Methods Retrospective, observational, single-centre study including all CD patients treated with Risankizumab between November 2023-September 2025. Collected variables: age, sex and previous treatments. Efficacy was evaluated in patients completing ≥24 weeks of treatment by comparing median stool frequency (SF) and faecal calprotectin (FC) levels before and after risankizumab using descriptive and comparative statistics. Data were obtained from electronic medical records and hospital prescription software.Results 50 patients were included (52% female), median age 53 years (range 21-73). All had received prior biologic therapies (49 anti-TNFα, 18 ustekinumab, eight vedolizumab, five upadacitinib). Median SF per day and FC before and after risankizumab were four (interquartile range, (IQR) 2-6) vs 3 (IQR 1-6) and 629 µg/g (IQR 276-2000) vs 323 µg/g (IQR 83-1890), respectively. A trend toward FC reduction in anti-IL23-naïve patients was observed (not statistically significant, p>0.05). One-year persistence was 91.7% (33/36 evaluable). six patients discontinued after a median of 51 weeks (IQR 24-59) due to inadequate clinical-biochemical response (5/6) or adverse events (1/6); three had prior ustekinumab. No significant difference in discontinuation rates was observed between anti-IL23-naïve and prior-ustekinumab groups (9.4% vs 16.7%, p=0.446). Treatment intensification was required in 22% overall (10/50 every 4 weeks; 1/50 every 6 weeks); 39% (7/18) prior-ustekinumab vs 12.5% (4/32) anti-IL23-naïve patients. The need for intensification was significantly higher in previously exposed patients (relative risk 3.11; 95% confidence interval 1.08-8.95; p=0.031).Conclusion and Relevance Prior ustekinumab exposure was associated with poorer response to risankizumab, requiring more frequent dose intensification. Further studies are needed to confirm these findings and clarify whether the number of previous treatment lines influences therapeutic outcomes.References and/or Acknowledgements NoneConflict of Interest No conflict of interest