Long-term outcome of risankizumab in Crohn’s disease: a real-world GETAID study
Mathurin Fumery
(1, 2)
,
Benedicte Caron
(3, 4)
,
Xavier Hébuterne
(5)
,
Romain Altwegg
(6)
,
Xavier Roblin
(7)
,
Carmen Stefanescu
(8)
,
Antoine Meyer
(9)
,
Maria Nachury
(10)
,
David Laharie
(11)
,
Catherine Le Berre
(12, 13)
,
Lucas Guillo
(14)
,
Amélie Biron
(15, 16)
,
Ludovic Caillo
(17)
,
Anthony Buisson
(18)
,
Stephane Nancey
(19, 20)
,
Mathieu Uzzan
(10, 21)
,
Lucine Vuitton
(22, 23)
,
Cyrielle Gilletta
(24)
,
Sophie Geyl
(25)
,
Antoine Blain
(26)
,
Julien Kirchgesner
(15, 27)
,
Philippe Ah-Soune
(28)
,
Nicolas Duveau
(29)
,
Mathias Vidon
(30)
,
Vered Abitbol
(31)
,
Thierry Paupard
(32)
,
My-Linh Tran-Minh
(33)
,
Antoine Defrance
(34)
,
Laurent Peyrin‐biroulet
(3, 4)
1
PERITOX -
Périnatalité et Risques Toxiques - UMR INERIS_I 1 UPJV
2 Service d'Hépato Gastroenterologie [CHU Amiens-Picardie]
3 Service d'Hépato-gastro-entérologie [CHRU Nancy]
4 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
5 CHU Nice - Centre Hospitalier Universitaire de Nice
6 Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi]
7 Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne]
8 Clinique Ambroise Paré [Centres Médico-Chirurgicaux Ambroise Pré, Pierre Cherest, Hartmann]
9 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
10 INFINITE - Institute for Translational Research in Inflammation - U 1286
11 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
12 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
13 TENS - The Enteric Nervous System in gut and brain disorders [U1235]
14 CHU Marseille
15 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
16 Hôpital Robert Debré
17 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
18 Service Hépato-Gastro-Entérologie [CHU Clermont-Ferrand]
19 HCL - Hospices Civils de Lyon
20 CIRI - Centre International de Recherche en Infectiologie
21 Service de gastro-entérologie [Henri Mondor AP-HP, Créteil]
22 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
23 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
24 Service Gastroentérologie, hépatologie nutrition, diabétologie et maladies héréditaires du métabolisme pédiatrique [CHU Toulouse]
25 Service d'Hépato-gastro-entérologie et Nutrition [CHU Dupuytren 1, Limoges]
26 IMM - Institut Mutualiste de Montsouris
27 CHU Saint-Antoine [AP-HP]
28 Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse
29 Centre Hospitalier de Roubaix
30 CHIC - Centre Hospitalier Intercommunal de Créteil
31 Hôpital Cochin [AP-HP]
32 Centre Hospitalier de Dunkerque
33 AP-HP - Hopital Saint-Louis [AP-HP]
34 GETAID - Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif
2 Service d'Hépato Gastroenterologie [CHU Amiens-Picardie]
3 Service d'Hépato-gastro-entérologie [CHRU Nancy]
4 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
5 CHU Nice - Centre Hospitalier Universitaire de Nice
6 Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi]
7 Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne]
8 Clinique Ambroise Paré [Centres Médico-Chirurgicaux Ambroise Pré, Pierre Cherest, Hartmann]
9 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
10 INFINITE - Institute for Translational Research in Inflammation - U 1286
11 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
12 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
13 TENS - The Enteric Nervous System in gut and brain disorders [U1235]
14 CHU Marseille
15 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
16 Hôpital Robert Debré
17 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
18 Service Hépato-Gastro-Entérologie [CHU Clermont-Ferrand]
19 HCL - Hospices Civils de Lyon
20 CIRI - Centre International de Recherche en Infectiologie
21 Service de gastro-entérologie [Henri Mondor AP-HP, Créteil]
22 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
23 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
24 Service Gastroentérologie, hépatologie nutrition, diabétologie et maladies héréditaires du métabolisme pédiatrique [CHU Toulouse]
25 Service d'Hépato-gastro-entérologie et Nutrition [CHU Dupuytren 1, Limoges]
26 IMM - Institut Mutualiste de Montsouris
27 CHU Saint-Antoine [AP-HP]
28 Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse
29 Centre Hospitalier de Roubaix
30 CHIC - Centre Hospitalier Intercommunal de Créteil
31 Hôpital Cochin [AP-HP]
32 Centre Hospitalier de Dunkerque
33 AP-HP - Hopital Saint-Louis [AP-HP]
34 GETAID - Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif
Mathurin Fumery
- Fonction : Auteur
- PersonId : 774088
- ORCID : 0000-0002-2337-2902
- IdRef : 170096289
Stephane Nancey
- Fonction : Auteur
- PersonId : 928425
- ORCID : 0000-0003-2088-1442
Laurent Peyrin‐biroulet
- Fonction : Auteur
- PersonId : 1111110
- ORCID : 0000-0003-2536-6618
- IdRef : 087640147
Résumé
Introduction
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 CD.
Patients and Methods
From May 2021 to August 2023, all consecutive CD patients 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 (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 (29%) patients 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. Half of the patients achieved steroid-free clinical remission after one year, and the safety profile was consistent with the literature.