P661 Comparable clinical efficacy, safety and immunogenicity of infliximab biosimilar (CT-P13) after transition from reference infliximab (Remicade®) in children with established inflammatory bowel disease: a multi-centre prospective observational study

Sładek, Małgorzata; Vultaggio, Alessandra; Ghione, S; Nencini, Francesca; Matucci, Andrea; Pratesi, Sara; Zanieri, F.; Maggi, Pietro; Paci, Monica; Ponanta-Gawron, K.; Kulig, Kenneth; Wasilewska, Agata; Lionetti, Paolo

doi:10.1093/ecco-jcc/jjx002.785

Cited by 3 publications

(3 citation statements)

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“…There is established evidence to show that the use of biosimilar infliximab (CT‐P13) in IBD is both safe and effective in the induction setting in patients who are anti‐TNF naïve (7–9). Evidence in the maintenance of remission setting in paediatrics is far more limited, yet initial results are promising and are added to by the data in this study.…”

Section: Discussionmentioning

confidence: 99%

“…patients on established infliximab therapy switching from originator to biosimilar (7)(8)(9). We now report prospective, nationwide, clinical safety, and efficacy data for patients from all 3 Scottish PIBD networks switching from originator infliximab to biosimilar infliximab.…”

Section: What Is Newmentioning

confidence: 99%

“…Following its launch in the United Kingdom for all indications in 2015, the safety, efficacy, and cost‐effectiveness of biosimilar infliximab in adult IBD has now been extensively shown from real‐world experiences and meta‐analysis both for initiation and switching (4,5). Limited PIBD‐specific data have shown similar safety and efficacy in the induction setting (3,6) with only preliminary data (including abstract results) available for paediatric patients on established infliximab therapy switching from originator to biosimilar (7–9). We now report prospective, nationwide, clinical safety, and efficacy data for patients from all 3 Scottish PIBD networks switching from originator infliximab to biosimilar infliximab.…”

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confidence: 99%

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

Gervais

McLean

Wilson

et al. 2018

J. pediatr. gastroenterol. nutr.

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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.

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Section: Discussionmentioning

confidence: 99%

Section: What Is Newmentioning

confidence: 99%

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confidence: 99%

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