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

Abstract

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.

References
1-de Souza HSP, Fiocchi C, Iliopoulos D. The IBD interactome: an integrated view of aetiology, pathogenesis and therapy. Nat Rev Gastroenterol Hepatol. 2017Dec;14(12):739–49
2-Ahmad T, Tamboli CP, Jewell D, Colombel JF. Clinical relevance of advances ingenetics and pharmacogeneticsof IBD. Gastroenterology. 2004 May;126(6):1533–49.
3-Feuerstein JD, Cheifetz AS. Crohn Disease: Epidemiology, Diagnosis, andManagement. Mayo Clin Proc. 2017 Jul;92(7):1088-1103. doi:10.1016/j.mayocp.2017.04.010.
4-Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, PeyrinBiroulet L, Danese S. Crohn’s disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi:10.1038/s41572-020-0156-2. Erratum in: Nat Rev Dis Primers. 2020 Apr 6;6(1):26. Erratum in: Nat Rev Dis Primers. 2020 May 20;6(1):42. Erratum in: Nat Rev Dis Primers. 2020 Jun 19;6(1):51. Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, et al. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74
5-Flynn S, Eisenstein S. Inflammatory Bowel Disease Presentation and Diagnosis. SurgClin North Am. 2019 Dec;99(6):1051-1062. doi: 10.1016/j.suc.2019.08.001. Epub 2019Sep 11. PMID: 31676047.
6-Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis, prevention, andtreatment methods of inflammatory bowel disease. J Med Life. 2019 Apr-Jun;12(2):113-122. doi: 10.25122/jml-2018-0075. PMID: 31406511; PMCID: PMC6685307.
7-Loftus EV Jr, Panés J, Lacerda AP, Peyrin-Biroulet L, D’Haens G, Panaccione R,Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728
8-D’Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M,Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panés J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn’s disease: results from thephase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May28;399(10340):2015-2030.doi: 10.1016/S0140-6736(22)00467-6. PMID: 35644154.
10-Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M,Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panés J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y,Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K,D’Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebocontrolled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May28;399(10340):2031-2046.doi: 10.1016/S0140-6736(22)00466-4. PMID: 35644155.