Title :

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study

Author(s) :

Fumery, Mathurin [Auteur]
Périnatalité et Risques Toxiques - UMR INERIS_I 1 UPJV [PERITOX]
Defrance, Antoine [Auteur]
Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif [GETAID]
Roblin, Xavier [Auteur]
Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne]
Altwegg, Romain [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Caron, Benedicte [Auteur]
Nutrition-Génétique et Exposition aux Risques Environnementaux [NGERE]
Hebuterne, Xavier [Auteur]
Centre Hospitalier Universitaire de Nice [CHU Nice]
Stefanescu, Carmen [Auteur]
Hôpital Beaujon [AP-HP]
Meyer, Antoine [Auteur]
Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
Nachury, Maria [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Laharie, David [Auteur]
Hôpital Haut-Lévêque [CHU Bordeaux]
Nancey, Stephane [Auteur]
Service d'Hépatologie et de Gastroentérologie [Lyon]
Le Berre, Catherine [Auteur]
The Enteric Nervous System in gut and brain disorders [U1235] [TENS]
Serrero, Melanie [Auteur]
Aix Marseille Université [AMU]
Geyl, Sophie [Auteur]
Giletta, Cyrielle [Auteur]
Service de Gastroentérologie et pancréatologie [CHU Toulouse]
Ah-Soune, Philippe [Auteur]
Duveau, Nicolas [Auteur]
Centre Hospitalier de Roubaix
Uzzan, Mathieu [Auteur]
Hôpital Beaujon [AP-HP]
Abitbol, Vered [Auteur]
Hôpital Cochin [AP-HP]
Biron, Amelie [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Tran-Minh, My-Linh [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Paupard, Thierry [Auteur]
Vuitton, Lucine [Auteur]
Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) [RIGHT]
Elgharabawy, Yasmine [Auteur]
Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif [GETAID]
Peyrin-Biroulet, Laurent [Auteur]
Nutrition-Génétique et Exposition aux Risques Environnementaux [NGERE]

Journal title :

Alimentary Pharmacology and Therapeutics

Abbreviated title :

Aliment. Pharmacol. Ther.

Volume number :

57

Pages :

426-434

Publication date :

2023-02-28

ISSN :

0269-2813

English keyword(s) :

Crohn's disease
effectiveness
induction therapy
risankizumab

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Background Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and ...
Show more >Background Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD. Methods From May 2021 to May 2022, all patients with refractory luminal CD treated with risankizumab in 22 French GETAID centres were retrospectively included. The primary endpoint was steroid-free clinical remission at week 12 (Harvey-Bradshaw [HB] score <5). Secondary endpoints included clinical response (≥3-point decrease of HB score and/or (HB) score <5), biochemical remission (CRP ≤ 5 mg/L), need for CD-related surgery and adverse events. Results Among the 100 patients included, all have been previously exposed to anti-TNF agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least three biologics) and 61 had a previous intestinal resection. All but three (97%) received a 600 mg risankizumab intravenous induction at weeks 0–4–8. At week 12, steroid-free clinical remission was observed in 45.8% of patients, clinical remission in 58% and clinical response in 78.5%. In subgroup analysis restricted to patients with objective signs of inflammation at baseline (n = 79), steroid-free clinical remission at week 12 was observed in 39.2% of patients. Biochemical remission was observed in 50% of patients. Six patients discontinued risankizumab before the week 12 visit due to lack of efficacy. CD-related hospitalisation was needed in six patients, and three underwent intestinal resection. In multivariable analysis, only a history of ustekinumab loss of response (vs primary failure) (odds ratio (OR), 2.80; 95% CI: 1.07–7.82; p = 0.041) was significantly associated with clinical remission at week 12. Twenty adverse events (AE) occurred in 20 patients including 7 serious AE corresponding to 6 CD exacerbation and one severe hypertension. Conclusion In a cohort of highly refractory patients with luminal CD and multiple prior drug failures including ustekinumab, risankizumab induction provided a clinical response in about 3 out of 4 patients and steroid-free clinical remission in about half of patients.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-11T23:51:27Z
2024-02-05T09:54:41Z