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Switching from Originator to Biosimilar Infliximab in Paediatric Inflammatory Bowel Disease is Feasible and Uneventful.

08:00 EDT 6th July 2018 | BioPortfolio

Summary of "Switching from Originator to Biosimilar Infliximab in Paediatric Inflammatory Bowel Disease is Feasible and Uneventful."

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.

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This article was published in the following journal.

Name: Journal of pediatric gastroenterology and nutrition
ISSN: 1536-4801
Pages:

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Medical and Biotech [MESH] Definitions

An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)

A species of Faecalbacterium, previously classified in the FUSOBACTERIUM genus, that is a major constituent of the GUT MICROBIOTA in healthy humans. It has anti-inflammatory activity and reduced numbers of this species occur in patients with INFLAMMATORY BOWEL DISEASES such as CROHN DISEASE.

A cytokine synthesized by T-LYMPHOCYTES that produces proliferation, immunoglobulin isotype switching, and immunoglobulin production by immature B-LYMPHOCYTES. It appears to play a role in regulating inflammatory and immune responses.

Gene rearrangement of the B-lymphocyte which results in a substitution in the type of heavy-chain constant region that is expressed. This allows the effector response to change while the antigen binding specificity (variable region) remains the same. The majority of class switching occurs by a DNA recombination event but it also can take place at the level of RNA processing.

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