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Switching From Originator to Biosimilar Infliximab in Paediatric Inflammatory Bowel Disease Is Feasible and Uneventful

Gervais, Lisa*; McLean, Luke L.*; Wilson, Michelle L.; Cameron, Carol; Curtis, Lee*; Garrick, Vikki*; Armstrong, Kat; Tayler, Rachel*; Henderson, Paul; Hansen, Richard*; Chalmers, Iain; Wilson, David C.; Russell, Richard K.*

Journal of Pediatric Gastroenterology and Nutrition: December 2018 - Volume 67 - Issue 6 - p 745–748
doi: 10.1097/MPG.0000000000002091
Short Communication: Gastroenterology: Inflammatory Bowel Disease

ABSTRACT The safety, clinical efficacy, and cost-effectiveness of biosimilar infliximab in adult inflammatory bowel disease (IBD) have now been extensively shown. Limited data have been collected in the paediatric setting. We report nationwide, prospective, clinical safety and effectiveness data for patients from all 3 Scottish paediatric inflammatory bowel disease networks switching from originator to biosimilar infliximab. Prospective clinical data were collected for 33 patients. Information was collected from electronic patient records, laboratory reports, and patient case notes. There were no clinically significant changes to disease activity, biomarkers, antidrug antibodies, or trough drug levels (P > 0.1) within a 12-month follow-up period; in addition, there were no significant adverse events reported. No infusion reactions were seen in the 264 infusions delivered. Switching from originator infliximab to the biosimilar (CT-P13) appears to be associated with neither an increase in infusion reactions nor significant loss of effectiveness in the short term.

*Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow

Department of Paediatric Gastroenterology, Royal Hospital for Sick Children, Edinburgh

Department of Paediatric Gastroenterology, Royal Aberdeen Children's Hospital, Aberdeen, UK.

Address correspondence and reprint requests to Lisa Gervais, DIP/HE Bachelor of Nursing, Child Branch, Royal Hospital for children, 1345 Govan Road, Glasgow, G51 4TF, UK (e-mail: lisa.gervais@nhs.net).

Received 18 May, 2018

Accepted 23 June, 2018

The work of the IBD team in Glasgow is supported by the Catherine McEwen foundation. R.K.R. is supported by an NHS senior research fellowship. R.H. and P.H. are funded by a career researcher fellowship from NHS Research Scotland. The work of the IBD team in Edinburgh is supported by the Edinburgh Children's Hospital Charity.

L.G. has received conference fees from Tillots May 2017 and V.G. from Abbvie 2017. R.T. was the speaker and received conference fees from Nutricia. R.H. received conference support, speaker's fees, and consultancy fees from Nutricia, MSD Immunology, Dr Falk, and 4D Pharma. D.C.W. received consultancy, speaker fees, and meeting expenses from Abbvie; consultancy from Takeda; and speaker fee from Falk. R.K.R. was supported/contracted by Research for Nestle Health Sciences plus Consulting Fees for Abbvie, Therakos, Celltrion, and Vifor. The remaining authors report no conflicts of interest.

© 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,