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P246. Safety and cost of infliximab for the treatment of Belgian pediatric patients with Crohn's disease

E. De Greef1, I. Hoffman2, G. D'Haens3, S. Van Biervliet4, F. Smets5, M. Scaillon6, O. Dewit7, H. Peeters8, I. Paquot9, P. Alliet10, W. Arts11, B. Hauser1, S. Vermeire12, A. Van Gossum13, J.‑F. Rahier14, I. Etienne15, E. Louis16, J.‑C. Coche17, J. Mahachie18, K. Van Steen19, G. Veereman20

1UZ Brussels, Brussels, Belgium; 2Uz Gasthuisberg, Pediatric Gastroenterology, Leuven, Belgium; 3Academic Medical Center, Gastroenterology and Endoscopy, Amsterdam, Netherlands; 4UZ Gent, Ghent, Belgium; 5UCL St Luc, Brussels, Belgium; 6Hôpital des Enfants Reine Fabiola, Brussels, Belgium; 7Cliniques Universitaires St-Luc, Department of Gastroenterology, Brussels, Belgium; 8Ghent University Hospital, Department of Gastroenterology, Ghent, Belgium; 9CHC Clinique de l'Esperence, Liège, Belgium; 10Jessa Hospital, Hasselt, Belgium; 11ZOL, Genk, Belgium; 12University Hospital Gasthuisberg, Department of Gastroenterology, Leuven, Belgium; 13Hôpital Erasme, Department of Gastroenterology, Brussels, Belgium; 14Cliniques Universitaires UCL Mont Godinne, Yvoir, Belgium; 15CHR De La Citadelle, Liège, Belgium; 16University of Liège and CHU Liège, Department of Gastroenterology, Liège, Belgium; 17Clinique Saint Pierre, Corroy Le Grand, Belgium; 18Montefiore Institute, ULG, Liège, Belgium; 19Montefiore Institute, System and Modeling Unit, Liège, Belgium; 20UZ Brussels, Pediatric Gastroenterology, Brussels, Belgium

Background: Biologicals have become an important component in the treatment of Crohn's disease in children. Their increased and long term use raises safety concerns.

We describe safety and cost of infliximab in a Belgian cohort of pediatric Crohn's disease patients.

Methods: All patients on infliximab as part of the present or past treatment for Crohn's Disease until January 1st 2011 were selected from an existing database. Information on disease phenotype, medication and adverse events were extracted.

Results: Adverse events occurred in 25.9% of patients exposed to infliximab of which 29.6% were severe. In total 31.7% of patients stopped infliximab therapy. The main reasons for discontinuation were adverse events in 45.4% and loss of response in 30.3%. No malignancies or lethal complications occurred over this 241 patient year observation period. Immunomodulators were concomitant medication in 75.9% of patients and were discontinued subsequently in 35.4% of them. The cost of infliximab infusions per treated patient per year in the Belgian health care setting is approximately 9 474 euro, including only medication and hospital related costs.

Conclusions: Even though infliximab is relatively safe in pediatric CD on the short term, close follow-up and an increased awareness of the possible adverse reactions is highly recommended. Adverse reactions appeared in 25.9% of all patients and were the main reason for discontinuation. Treatment cost has to be balanced against efficacy and modifications in disease course. In the Belgian health care system, the medication is available to all patients with moderate to severe CD.