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* = Presenting author

P456 First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population.

D. Jarzebicka*1, A. Plocek2, J. Sieczkowska1, E. Toporowska-Kowalska2, J. Kierkus1

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

Background

Biological treatment in ulcerative colitis (UC) is employed after the failure of standard treatment. Introduction of biosimilar infliximab (INF) (Remsima/Inflectra) in European Union allows gaining first experience with this medicine in children with ulcerative colitis. Biosimilar infliximab was authorised in all indications on the basis of in-depth review of preclinical and clinical data. However, the use in children with ulcerative colitis was not reported previously.

Methods

Six patients starting treatment with biosimilar infliximab Remisma (5 mg/kg) was assessed at week 10 after receiving 3 doses at weeks 0, 2 and 6. Disease activity (PUCAI) and laboratory values (CRP, ESR, platelet count) was assessed at the start of the biological therapy and at week 10. Mean and range of clinical values is reported.

Results

Median age of 6 patients was 12.3 years (range 8.5-17.5). Mean PUCAI before infliximab initiation was 47.5 (range 5-80). Mean (range) CRP, ESR and platelet count before initiation were 1.8 mg/dL (0.03-8.1), 24 mm (5-33) and 370x109/L (260-530x109). For one patient it was the second course of biological treatment (3 doses of the reference INF received 9 months ago. For 2 patients (33%) treatment was discontinued, in 1 due to lack of response after first dose (disease flare), in second due to anaphylactic reaction during dose 3 infusion. For the latter patient that was the second course of infliximab treatment. As of November 2014 3 patients (50%) received 3 doses and were evaluated at week 10. For these patients initial values of PUCAI, CRP, ESR and platelet count were not different than for all 6 patients. After 3 doses of biosimilar infliximab PUCAI values decreased to 28.3 (range 5-50). CRP, ESR and platelet count were 0.3 (0.02-0.68), 20 (10-28) and 418x109 (236-706), respectively.

Conclusion

Initial observations point to efficacy and safety of biosimilar infliximab in the treatment of pediatric patients with ulcerative colitis. Further studies with larger patient groups are required. Data for more patients and longer observation time will be collected and presented.