ClinGastroenterolHepatol. 2024Dec;22(12):24512458.e1.doi:10.1016/j.cgh.2024.04.016. Epub 2024 May 9.

Mathurin Fumery ¹, Benedicte Caron ², Xavier Hébuterne ³, Romain Altwegg ⁴, Xavier Roblin ⁵, Carmen Stefanescu ⁶, Antoine Meyer ⁷, Maria Nachury ⁸, David Laharie ⁹, Catherine Le Berre ¹⁰, Lucas Guillo ¹¹, Amélie Biron ¹², Ludovic Caillo ¹³, Anthony Buisson ¹⁴, Stephane Nancey ¹⁵, Mathieu Uzzan ¹⁶, Lucine Vuitton ¹⁷, Cyrielle Gilletta ¹⁸, Sophie Geyl ¹⁹, Antoine Blain ²⁰, Julien Kirchgesner ²¹, Philippe Ah-Soune ²², Nicolas Duveau ²³, Mathias Vidon ²⁴, Vered Abitbol ²⁵, Thierry Paupard ²⁶, My-Linh Tran-Minh ²⁷, Antoine Defrance ²⁸, Laurent Peyrin-Biroulet ²⁹

Author information

¹Department of Gastroenterology, Amiens University hospital, and PeriTox, Université de Picardie, France. Electronic address: fumery.mathurin@chu-amiens.fr.

²Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France and INSERM, NGERE, University of Lorraine, F-54000 Nancy, France and INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France.

³Department of Gastroenterology and Clinica Nutrition, CHU of Nice, Nice, France and University Côte d'Azur, Nice, France.

⁴Department of Gastroenterology, CHU de Montpellier, France.

⁵Department of Gastroenterology, CHU de Saint-Etienne, France.

⁶Institut des MICI, Clinique Ambroise Paré-Hartmann, Neuilly-sur-Seine, France.

⁷Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre & Université Paris-Saclay, Le Kremlin Bicêtre, France.

⁸Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, Lille, France.

⁹CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et oncologie digestive - Université de Bordeaux, F-33000 Bordeaux, France.

¹⁰Hépato-Gastro-Entérologie et Assistance Nutritionnelle, Inserm CIC 1413, Inserm UMR 1235, Institut des Maladies de l'Appareil Digestif (IMAD), Nantes Université, CHU Nantes, Nantes, France.

¹¹Department of Gastroenterology, University Hospital of Marseille Nord, Assistance Publique-Hôpitaux de Marseille (AP-HM), University of Aix-Marseille, Marseille, France.

¹²Department of Gastroenterology, CHU de Reims, France.

¹³Department of Gastroenterology, CHU de Nîmes, France.

¹⁴Department of Gastroenterology, CHU de Clermont-Ferrand, France.

¹⁵Department of Gastroenterology, CHU de Lyon, Lyon-Sud hospital, Pierre-Benite, France and INSERM U1111-CIRI, Lyon, France.

¹⁶Paris Est Créteil University UPEC, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Gastroenterology Department, Créteil F-94010, France.

¹⁷Department of Gastroenterology, and UMR Right Inserm, Besançon university hospital, University of Franche-Comté, Besançon, France.

¹⁸Department of Gastroenterology and Pancreatology, CHU of Toulouse Rangueil, France.

¹⁹Department of Gastroenterology, CHU Limoges Dupuytren, France.

²⁰Department of Gastroenterology, Hopital Montsouris, Paris, France.

²¹INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Department of Gastroenterology, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.

²²Department of Gastroenterology, Toulon, France.

²³Department of Gastroenterology, Roubaix, France.

²⁴Department of Gastroenterology, Centre Hospitalier intercommunal de Creteil.

²⁵Department of Gastroenterology, Cochin Hospital, Paris, France.

²⁶Department of Gastroenterology, Centre Hospitalier de Dunkerque, France.

²⁷Department of Gastroenterology, Saint-Louis Hospital, Paris, France.

²⁸Groupe d'étude des affections inflammatoires du tube digestif, GETAID, Paris, France.

²⁹Department of Gastroenterology, INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

Abstract

Background & aims: The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with Crohn's Disease (CD).

Methods: From May 2021 to August 2023, all consecutive patients with CD treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index [HBI] <5) at 52 weeks.

Results: Of the 174 patients included, 99%, 93%, and 96% had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. All patients had received ≥3 biologics, and 108 (62%) had previous intestinal resection. Median follow-up was 13.7 months (interquartile range, 10.0-18.1 months). The rates of steroid-free clinical remission and clinical remission at week 26 were 47% (72/152) and 52% (79/152), and 46% (58/125), and 48% (60/125) at week 52, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174; 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174; 20.9%) were hospitalized, and 22 (22/174; 12.6%) required intestinal resection. Fifty-one patients (29%) had an adverse event, including 26 (15%) serious adverse events (CD flare, n = 17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed.

Conclusion: This is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. One-half of the patients achieved steroid-free clinical remission after 1 year, and the safety profile was consistent with the literature.