| アブストラクト | OBJECTIVES: neurologic adverse effects (NAE) 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 non-infective NAE associated with anti-TNFalpha antibodies in pediatric IBD, and to evaluate their incidence. METHODS: we retrospectively collected all reports of NAE in pediatric IBD treated with anti-TNFalpha 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. RESULTS: between 2000 and 2018, 231 adverse events in pediatric IBD exposed to anti-TNFalpha antibodies were reported to this Database. 17 NAE (7.36%) were collected: 8 severe NAE (one demyelinating neuropathy, one optic neuritis, one acute transverse myelitis, one polyradiculoneuritis, one sensorineural hearing loss, one seizure, one stroke, and one glioma), 7 moderate NAE (headaches), and 2 neuropsychic events. The median delay between anti-TNFalpha start and NAE occurrence was 6 months (range: 13 days to 26 months). In 10/17 patients, anti-TNFalpha antibodies were stopped. 9/17 patients had a complete resolution (including 2 severe NAE) and 8/17 a partial resolution (including 6 severe NAE). We estimate the incidence of severe NAE in pediatric IBD treated with anti-TNFalpha antibodies at 1 case for 10 000 patients-year in France. CONCLUSIONS: NAE associated with anti-TNFalpha antibodies in pediatric IBD are rare. In severe NAE, we recommend to discontinuate anti-TNFalpha therapy and to consider alternative treatment. |
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| 投稿者 | Bertrand, Valerie; Massy, Nathalie; Pigneur, Benedicte; Coopman, Stephanie; Durrieu, Genevieve; Gaboriau, Louise; Langlois, Vincent; Gower-Rousseau, Corinne; Hugot, Jean-Pierre; Ruemmele, Frank M |
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| 組織名 | Departement de pediatrie, Hopital Jacques Monod, BP 24, 76083 Le Havre cedex,;FranceA list of investigators and study centres appears in the Appendix.;Centre Regional de Pharmacovigilance, Institut de Biologie Clinique, Hopital;Charles Nicolle, CHU de Rouen, 76031 ROUEN CEDEX.;Assistance Publique-Hopitaux de Paris (APHP), Hopital Necker Enfants Malades,;Service de Gastroenterologie pediatrique, Paris, France.;Division of Gastroenterology, Hepatology and Nutrition, Department of;Paediatrics, Jeanne de Flandre Lille University Children's Hospital, F-59000,;France.;Centre Regional de Pharmacovigilance, Pharmacologie clinique, Faculte de medecine;de Purpan, 37, allees Jules Guesde - 31073 Toulouse cedex.;Centre Regional de Pharmacovigilance, Pharmacologie medicale, Faculte de;medecine, CHU Lille, 59037 Lille, France.;Departement de medecine interne et maladies infectieuses, Hopital Jacques Monod,;BP 24, 76083 Le Havre cedex, France.;Departement de neurophysiologie, centre de competence neuro-musculaire regional,;Hopital Charles Nicolle, CHU de Rouen, 76031 ROUEN CEDEX.;Public Health Unit, Epimad Registry, Inserm UMR 995 LIRIC, Universite Lille Nord;de France, CHRU Lille, Lille, France.;Hopital Robert Debre, Assistance Publique Hopitaux de Paris.;Universite Sorbonne Paris Cite, Paris Descartes, Faculte de Medecine, Paris,;Institut IMAGINE, INSERM 1163, Paris, France. |
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