Titre :

Neurological adverse effects associated with anti-tumor necrosis factor alpha antibodies in pediatric inflammatory bowel diseases

Auteur(s) :

Bertrand, Valerie [Auteur]
Groupe Hospitalier du Havre Hôpital Jacques Monod (MONTIVILLIERS) [GHH]
Massy, Nathalie [Auteur]
Centre Régional de Pharmacovigilance [CRPV]
Pigneur, Benedicte [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Coopman, Stephanie [Auteur]
Hôpital Jeanne de Flandre [Lille]
Durrieu, Genevieve [Auteur]
Centre Régional de Pharmacovigilance [CRPV]
Gaboriau, Louise [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Langlois, Vincent [Auteur]
Groupe Hospitalier du Havre Hôpital Jacques Monod (MONTIVILLIERS) [GHH]
Gower, Corinne [Auteur]
498252|||Lille Inflammation Research International Center - U 995 [LIRIC]
Hugot, Jean-Pierre [Auteur]
Centre de recherche sur l'Inflammation [CRI (UMR_S_1149 / ERL_8252 / U1149)]
Ruemmele, Frank M. [Auteur]
Imagine - Institut des maladies génétiques (IHU) [Imagine - U1163]

Titre de la revue :

Journal of Pediatric Gastroenterology and Nutrition

Nom court de la revue :

J. Pediatr. Gastroenterol. Nutr.

Numéro :

70

Pagination :

841-848

Date de publication :

2020-06-01

ISSN :

1536-4801

Mot(s)-clé(s) en anglais :

anti-TNF alpha antibodies
pediatric inflammatory bowel disease
neurological adverse effects

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Neurological adverse effects (NAEs) induced by biotherapies have been reported in the literature mainly in adult patients with inflammatory bowel disease (IBD), rheumatic diseases, or psoriasis. There are scant data in ...
Lire la suite >Neurological adverse effects (NAEs) induced by biotherapies have been reported in the literature mainly in adult patients with inflammatory bowel disease (IBD), rheumatic diseases, or psoriasis. There are scant data in children. Aims of this study are to report and describe noninfective NAE associated with anti-TNFα antibodies in pediatric IBD, and to evaluate their incidence. We retrospectively collected all reports of NAE in pediatric IBD treated with anti-TNFα antibodies recorded in the French Pharmacovigilance Database. To estimate the national incidence of NAEs, we extrapolated data from the French regional inception population-based cohort EPIMAD. Between 2000 and 2018, 231 adverse events in pediatric IBD exposed to anti-TNFα antibodies were reported to this Database. Seventeen NAEs (7.36%) were collected: 8 severe NAE (1 demyelinating neuropathy, 1 optic neuritis, 1 acute transverse myelitis, 1 polyradiculoneuritis, 1 sensorineural hearing loss, 1 seizure, 1 stroke, and 1 glioma), 7 moderate NAE (headaches), and 2 neuropsychic events. The median delay between anti-TNFα start and NAE occurrence was 6 months (range: 13 days to 26 months). In 10 of 17 patients, anti-TNFα antibodies were stopped. Nine of 17 patients had a complete resolution (including 2 severe NAE) and 8 of 17 a partial resolution (including 6 severe NAE). We estimate the incidence of severe NAE in pediatric IBD treated with anti-TNFα antibodies at 1 case for 10,000 patients-year in France. NAE associated with anti-TNFα antibodies in pediatric IBD are rare. In severe NAE, we recommend to discontinue anti-TNFα therapy and to consider alternative treatment.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

CHU Lille
Inserm
Université de Lille

Collections :

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

Date de dépôt :

2021-07-06T12:47:52Z
2024-01-24T13:07:06Z