4CPS-049 Effectiveness and safety of risankizumab as induction therapy for Crohn’s disease

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Background and Importance Risankizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease and an inadequate response or intolerance to the conventional treatment and a biological anti-TNF-α drug or in contraindication of these. Different studies have demonstrated promising efficacy and safety with risankizumab. Real-life studies are commonly performed to confirm these results. Aim and Objectives To analyse the effectiveness and safety of risankizumab as induction therapy in clinical practice for the treatment of Crohn’s disease in a tertiary hospital. Material and Methods Observational, retrospective, single-centre study that included all patients with moderately to severely active Crohn’s disease treated with risankizumab between September/2023-April/2024. Those patients who had not completed the induction period were excluded from the study. Variables collected: age, sex, previous biological therapies, adverse events (AEs), interruptions and their causes. To evaluate effectiveness, the symptomatic improvement reported by patients was analysed(improvement being considered the absence of abdominal pain, fever and vomiting). In addition, the average daily stool frequency and faecal calprotectin (CPF) value were measured before and after completed induction. Data were obtained from the electronic medical record and prescription software. Results 35 patients (42.9% men) were included; median age 45 (interquartile range (IQR) =19–75) years. 82.9% patients had received anti-TNF-α therapy, with a median 2 (IQR=0–4) previous biological treatments. At the date of data collection, all patients had received a dose of 360mg at week-12, with a median treatment duration of 28 weeks. 15 patients (42.9%) reported symptomatic improvement at the end of the study, although 60% (n=21) continued with abdominal pain and the daily frequency of bowel movements remained high (>5 per day) in 54.3% (n=19). The median level of CPF was reduced by 56.6% [973.4 (IQR10.7–5051.4) vs 422.4 (IQR0–5217.3) mcg/g] after induction with risankizumab and no patient had disease outbreak during induction treatment. One patient reported oedema in the lower limbs. No patient discontinued treatment due to AEs. Conclusion and Relevance Risankizumab was effective and well tolerated as induction therapy in our patients, although it appears to improve analytical parameters to a greater extent without this translating into symptomatic improvement. Further studies with a larger sample size and longer follow-up period are needed to confirm these real-life results. References and/or Acknowledgements Conflict of Interest No conflict of interest

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