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

被引：26

作者：

Gervais, Lisa ^{[1
]}

McLean, Luke L. ^{[1
]}

Wilson, Michelle L. ^{[2
]}

Cameron, Carol ^{[3
]}

Curtis, Lee ^{[1
]}

Garrick, Vikki ^{[1
]}

Armstrong, Kat ^{[2
]}

Tayler, Rachel ^{[1
]}

Henderson, Paul ^{[2
]}

Hansen, Richard ^{[1
]}

Chalmers, Iain ^{[3
]}

Wilson, David C. ^{[2
]}

Russell, Richard K. ^{[1
]}

机构：

[1] Royal Hosp Children, Dept Paediat Gastroenterol, Glasgow, Lanark, Scotland

[2] Royal Hosp Sick Children, Dept Paediat Gastroenterol, Edinburgh, Midlothian, Scotland

[3] Royal Aberdeen Childrens Hosp, Dept Paediat Gastroenterol, Aberdeen, Scotland

来源：

JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION | 2018年 / 67卷 / 06期

关键词：

anti-tumor necrosis factor; chron's disease; ulcerative colitis; EVIDENCE-BASED CONSENSUS; ACTIVITY INDEX; CT-P13; MANAGEMENT; DIAGNOSIS;

D O I：

10.1097/MPG.0000000000002091

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：745 / 748

页数：4

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