TY - JOUR
T1 - Switching from originator to biosimilar infliximab in paediatric inflammatory bowel disease is feasible and uneventful
AU - Gervais, Lisa
AU - McLean, Luke L.
AU - Wilson, Michelle L.
AU - Cameron, Carol
AU - Curtis, Lee
AU - Garrick, Vikki
AU - Armstrong, Kat
AU - Tayler, Rachel
AU - Henderson, Paul
AU - Hansen, Richard
AU - Chalmers, Iain
AU - Wilson, David C.
AU - Russell, Richard K.
N1 - Publisher Copyright:
© 2019 ESPGHAN and NASPGHAN.
PY - 2018/12
Y1 - 2018/12
N2 - 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.
AB - 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.
KW - Anti-Tumor Necrosis Factor
KW - Chron's Disease
KW - Ulcerative Colitis
UR - http://www.scopus.com/inward/record.url?scp=85054688373&partnerID=8YFLogxK
U2 - 10.1097/MPG.0000000000002091
DO - 10.1097/MPG.0000000000002091
M3 - Article
C2 - 29985877
AN - SCOPUS:85054688373
SN - 0277-2116
VL - 67
SP - 745
EP - 748
JO - Journal of Pediatric Gastroenterology and Nutrition
JF - Journal of Pediatric Gastroenterology and Nutrition
IS - 6
ER -