CP-104 Infliximab utilisation study in a tertiary paediatric hospital

Background Infliximab is a monoclonal antibody to tumour necrosis factor, approved in paediatric patients for moderate–severe inflammatory bowel disease (IBD)—both Crohn’s disease (CD) and ulcerative colitis (UC). Induction regimen consists of 5 mg/kg dose given at weeks 0, 2 and 6, followed by a maintenance regimen of 5 mg/kg every 8 weeks. An intensification strategy, increase in dose, decrease in interval infusions or both is suggested for treatment failure. Purpose To describe the patterns of infliximab use in a tertiary paediatric hospital. Material and methods This was a cross sectional study including all patients treated with infliximab in a maintenance regimen. The variables analysed were: age, prescribing service, indication, and dosing and interval infusions. Results 46 patients were analysed with a median age of 15 years (4–19). Label indications were 37 patients with IBD: CD (21/46) and UC (16/46). Off-label indications supported by clinical evidence were 9: juvenile idiopathic arthritis associated uveitis (JIA-U) (6/46); and others—idiopathic uveitis (1/46), Blau syndrome(1/46) and sarcoidosis(1/46). Mean adjusted monthly dose was 5.4 mg/kg, higher doses were prescribed in patients with a rheumatological diagnosis (8.4 mg/kg for JIA-U, 6.3 mg/kg for others), followed by UC (5.8 mg/kg) and CD (4.1 mg/kg). Infliximab interval was shortened in 25/46 patients. Analysed by indications: patients with UC (11/21), patients with CD (6/16), patients with JIA-U (6/6) and patients with other diseases(2/3). The dose was stepped up and the interval shortened in 15/46 patients. Conclusion Infliximab in paediatrics is used mostly for labelled indications, UC and CD. Indications of infliximab prescribed as off-label treatment in our centre were for JIA-U, idiopathic uveitis, Blau syndrome and sarcoidosis. About half of patients were treated using an intensification strategy, higher doses and/or shortened interval infusions. The real dosage of infliximab is higher than the summaries of product characteristics dosage but high doses are reported in the literature as a good option to optimise treatment, and some studies recommend this option as a good way to prevent infliximab antibody formation. Further studies are necessary to clarify which is the best option to achieve a response using the minimum dose with maximum patient benefit. No conflict of interest