Effectiveness and safety of ustekinumab ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
Permalink :
Title :
Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study
Author(s) :
Fumery, Mathurin [Auteur]
CHU Amiens-Picardie
Filippi, Jérôme [Auteur]
Centre Hospitalier Universitaire de Nice [CHU Nice]
Abitbol, V. [Auteur]
Biron, A. [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Laharie, D. [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Serrero, M. [Auteur]
CHU Marseille
Altwegg, R. [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Bouhnik, Y. [Auteur]
Peyrin-Biroulet, L. [Auteur]
Centre Hospitalier Universitaire de Nancy [CHU Nancy]
Gilletta, C. [Auteur]
Service de Gastroentérologie et pancréatologie [CHU Toulouse]
Roblin, X. [Auteur]
Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] [CHU ST-E]
De Chambrun, G. P. [Auteur]
Vuitton, L. [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Service de Gastro-Entérologie [CHRU Besançon]
Bourrier, A. [Auteur]
Nancey, S. [Auteur]
Gornet, J. M. [Auteur]
Nahon, S. [Auteur]
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Bouguen, G. [Auteur]
Nutrition, Métabolismes et Cancer [NuMeCan]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Viennot, S. [Auteur]
Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen]
Nachury, Maria [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Amiot, A. [Auteur]
CHI Créteil
Service de gastro-entérologie [Henri Mondor AP-HP, Créteil]
CHU Amiens-Picardie
Filippi, Jérôme [Auteur]
Centre Hospitalier Universitaire de Nice [CHU Nice]
Abitbol, V. [Auteur]
Biron, A. [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Laharie, D. [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Serrero, M. [Auteur]
CHU Marseille
Altwegg, R. [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Bouhnik, Y. [Auteur]
Peyrin-Biroulet, L. [Auteur]
Centre Hospitalier Universitaire de Nancy [CHU Nancy]
Gilletta, C. [Auteur]
Service de Gastroentérologie et pancréatologie [CHU Toulouse]
Roblin, X. [Auteur]
Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] [CHU ST-E]
De Chambrun, G. P. [Auteur]
Vuitton, L. [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Service de Gastro-Entérologie [CHRU Besançon]
Bourrier, A. [Auteur]
Nancey, S. [Auteur]
Gornet, J. M. [Auteur]
Nahon, S. [Auteur]
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Bouguen, G. [Auteur]
Nutrition, Métabolismes et Cancer [NuMeCan]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Viennot, S. [Auteur]
Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen]
Nachury, Maria [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Amiot, A. [Auteur]
CHI Créteil
Service de gastro-entérologie [Henri Mondor AP-HP, Créteil]
Journal title :
Alimentary Pharmacology and Therapeutics
Abbreviated title :
Aliment. Pharmacol. Ther.
Volume number :
-
Pages :
-
Publication date :
2021-07-30
ISSN :
0269-2813
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Background
Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real-life long-term data are currently available.
Aims
To assess the real-world effectiveness ...
Show more >Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real-life long-term data are currently available. Aims To assess the real-world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti-TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid-free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3-10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one-half of patients with refractory UC were still treated by ustekinumab and one-third were in steroid-free clinical remission.Show less >
Show more >Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real-life long-term data are currently available. Aims To assess the real-world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti-TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid-free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3-10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one-half of patients with refractory UC were still treated by ustekinumab and one-third were in steroid-free clinical remission.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Submission date :
2024-01-12T06:21:37Z
2024-02-27T13:34:08Z
2024-02-27T13:34:08Z