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* = Presenting author

P530 Efficacy of biosimilar infliximab induction therapy in paediatric patients with Crohn’s disease: 1.5 years of experience

J. Sieczkowska*1, A. Plocek2, A. Banaszkiewicz3, D. Jarzebicka1, A. Gawronska3, E. Toporowska-Kowalska2, J. Kierkus1

1The Children’s Memorial Health Institute, Department of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, Warsaw, Poland, 2Medical University of Łódź, Department of Paediatric Allergology, Gastroenterology and Nutrition, Łódź, Poland, 3Medical University of Warsaw, Department of Paediatric Gastroenterology and Nutrition, Warsaw, Poland

Background

Infliximab biosimilars has been approved in therapy of IBD paediatric patients by extrapolation of indications of originator. The aim of the study was to assess the efficacy of induction therapy with biosimilar in Crohn’s disease paediatric patients.

Methods

This study had been performed in 3 Polish hospitals. All patients with Crohn’s disease who had biological therapy with biosimilar applied between March 2014 and July 2015 were enrolled to the study. The patients received induction doses of biosimilar 5 mg/kg at week 0, 2, and 6. The change in PCDAI (Paediatric Crohn’s Disease Activity Index) scoring was primary endpoint in the assessment of efficacy. Patient characteristics, previous history of anti-tumour necrosis factor administration, response and remission to treatment, and adverse drug reaction were also analysed.

Results

In total, 36 children (19 M and 17 F) were enrolled to the study. Mean age at diagnosis was 11.8 (12.2; 0.8–17.1). 17 patients were anti-TNF naïve, and 9 had previous anti-tumour necrosis factor treatment. Mean PCDAI before first biosimilar dose was 49.7 (median 52.5; 5–87.5) vs 10.1 (5; 0–47.5) week 14. Clinical response and remission after 3 initial doses were achieved in 32/36 (88.9%) and 26/32 (72%) patients, respectively. Two patients did not complete induction therapy. We observed 1 allergic reaction during second biosimilar infusion, which led to treatment discontinuation.

Conclusion

Induction therapy with biosimilar in Crohn’s disease paediatric patients is effective and safe.