Abstract / Description of output
The safety, clinical efficacy and cost-effectiveness of biosimilar infliximab in adult inflammatory bowel disease (IBD) have now been extensively shown. Limited data has been collected in the paediatric setting. We report nationwide, prospective, clinical safety and effectiveness data for patients from all three Scottish paediatric IBD (PIBD) networks switching from originator to biosimilar infliximab.Prospective clinical data was 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, anti drug antibodies or trough drug levels (p > 0.1) within a 12-month follow up period; additionally 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.
Original language | English |
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Journal | Journal of pediatric gastroenterology and nutrition |
Early online date | 6 Jul 2018 |
DOIs | |
Publication status | E-pub ahead of print - 6 Jul 2018 |