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* = Presenting author

P430 Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report.

J. Sieczkowska*1, A. Banaszkiewicz2, A. Plocek3, D. Jarzebicka1, A. Gawronska2, E. Toporowska-Kowalska3, J. Kierkus1

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

Background

Biosimilar infliximab (Remisma/Inflectra) was introduced into therapy in Poland and other selected European countries at the beginning of 2014. Biosimilar infliximab (BI) was authorised based on preclinical and clinical studies and is considered therapeutically equivalent in terms of safety and efficacy to the reference infliximab. We present first, to our knowledge, observation on the safety and efficacy of BI in children with Crohn disease.

Methods

A total of 12 children diagnosed and treated at 3 Polish hospitals with Crohn disease who started therapy with BI were assessed. Patients received BI 5 mg/kg at weeks 0, 2, and 6. Pediatric Crohn disease activity index (PCDAI) and laboratory values (CRP, ESR, platelet count) were assessed at qualification for the biological treatment and after induction treatment at week 10. Due to small number of cases, median and range of clinical values are reported for descriptive purposes only.

Results

Median age was 15.1 years (range 2-18). At BI start median PCDAI was 52.5 (range 5-65); CRP, ESR, platelet count values were 0.9 mg/dL (0.15-6.4), 18 mm (10-93), 327x109/L (235-602x109), respectively. Five out of 12 patients were previously treated with a biologics (4 with reference infliximab, 1 with adalimumab). Time of previous treatment was 6-59 months with biologic-free interval of 7-72 months. Treatment was discontinued in 2/12 patients (17%) after first BI dose due to lack of response, accompanied by adverse event in one patient and withdrawal of consent in second patient. In 10/12 patients (83%) response was observed as assessed by significant PCDAI and inflammation markers decrease. As of November 2014, 6 out of 12 patients (50%) received all 3 induction doses. For those patients, median initial PCDAI was 52.5 (15-62.5) and decreased to 5 (2.5-10) . Before treatment and at week 10 CRP, ESR and platelet count were 1.0 (0.15-6.4), 28 (16-93), 309x109 (255-553) and 0.2 (0.04-0.82), 16 (8-29), 263x109 (220-340), respectively. Adverse events during infusion were observed in 2/12 patients (17%) : one anaphylactic reaction leading to treatment discontinuation and one blood pressure rise that resolved after infusion rate lowering. In the latter case patient received all 3 doses of BI.

Conclusion

In this preliminary report BI appears to be safe and efficacious in inducing remission in Crohn disease paediatric patients. No unexpected safety and product quality issues were identified.