Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study.

Abstract

Background:

The relatively high cost and patent expiry of infliximab, an anti-tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients.

Methods:

In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group). Primary end points were the proportion of patients continuously receiving infliximab and the proportion achieving persistent remission-corticosteroid-free sustained clinical remission without dose intensification-at 1 year.

Results:

Thirty-six patients were recruited to the RP maintenance group and 38 to the CT-P13 switch group. At 1 year in the RP maintenance group and CT-P13 switch group, 86.1% (31/36) and 92.1% (35/38) patients had continuously received infliximab (P = 0.649), and 77.8% (28/36) and 78.9% (30/38) patients experienced persistent remission (P = 1.000), respectively. There were no statistically significant differences in any measures of disease activity, pharmacokinetics, or immunogenicity between the time of switch and 1-year postswitch in the CT-P13 switch group. Twenty-seven adverse events occurred in the maintenance group and 30 in the switch group.

Conclusions:

Switching from maintenance infliximab RP to CT-P13 did not result in any significant differences in efficacy, pharmacokinetics, or immunogenicity in patients with pediatric-onset IBD, and no unexpected safety issues occurred, supporting findings from randomized controlled trials.

• Authors: Ben Kang, Yoon Lee, Kiwuk Lee, Young Ok Choi, Yon Ho Choe
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 24 Issue 3 Pg. 607-616 (02 15 2018) ISSN: 1536-4844 [Electronic] England
• PMID: 29390113 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 Crohn’s & Colitis Foundation of America. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected]

Chemical References

• Antibodies, Monoclonal
• Biosimilar Pharmaceuticals
• CT-P13
• Infliximab

Topics

• Adolescent
• Antibodies, Monoclonal (therapeutic use)
• Biosimilar Pharmaceuticals (therapeutic use)
• Child
• Drug Substitution
• Female
• Humans
• Inflammatory Bowel Diseases (drug therapy)
• Infliximab (therapeutic use)
• Male
• Prospective Studies
• Remission Induction
• Republic of Korea
• Treatment Outcome