P0819 AIRIS-Crohn: Results on the Effectiveness and Safety of Risankizumab in the Medium Term in Real-World Clinical Practice
Authors: Caballero Mateos A M , Olmedo Martín R V , Gijón-Villanova R , Gutiérrez-Holanda C , Fernández-Moreno N , Martín-Rodríguez M D M , Silva-Albarellos E , Rodríguez-González F J , Hernández-Martínez Á , Benítez J M , Mata F J , Trapero-Martínez A M , Valdés-Delgado T ,   GATEII
Published: January 2025

Background

There is a lack of evidence on the effectiveness and safety of Risankizumab in Crohn’s disease in real-world clinical practice. This observational study aims to analyze these outcomes in patients with Crohn’s disease in Andalusia (Spain).

Methods

Retrospective clinical and biochemical data were collected from patients who initiated treatment with Risankizumab across 10 hospitals in Andalusia (AIRIS-Crohn registry). Clinical remission was defined as a Harvey-Bradshaw Index (HBI) score &lt;5. Combined clinical-biochemical remission was defined as HBI &lt;5, C-reactive protein (CRP) &lt;5 mg/L, and fecal calprotectin &lt;250 μg/g. Steroid-free remission was defined as HBI &lt;5 and no corticosteroid use since week 12. An intention-to-treat analysis was performed.

Results

A total of 138 patients were included, with a mean age of 49 years (range 19-84), of which 50.8% were male. The disease distribution was ileocolonic in 46%, ileal in 45.7%, and colonic in 8.3%, with 5.9% having upper disease localization. The smoking status included 23% active smokers and 27% former smokers. Extra-intestinal manifestations were present in 31%, and 20.8% had associated perianal disease. The mean duration of disease was 15 years (range 0-55), and 39.7% had undergone resective surgery. The mean of previous advanced treatments was 3. At baseline, 9% were on 5-ASA, 3.6% on immunomodulators, and 32% were taking corticosteroids. The induction phase lasted 12 weeks for all patients. After 6 months, 84.6% continued on a 360 mg dose every 8 weeks, 9.6% required intensification to every 6 weeks, and 5.8% every 4 weeks. (Table 1.a)

Clinical and Biochemical Effectiveness Results are shown in Table 1.b. Fifteen patients discontinued treatment before the 6-month mark (12.5%), primarily due to primary failure (60%). Three patients experienced skin reactions leading to treatment discontinuation: one due to hypersensitivity and another due to hepatotoxicity. Two mild, transient adverse events were reported: elevated transaminases and a skin reaction, both resolving without treatment discontinuation.

Conclusion

Risankizumab demonstrated both effectiveness and safety in a cohort of patients with refractory Crohn’s disease.

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