Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study
- Authors
- Kang, Ben; Lee, Yoon; Lee, Kiwuk; Choi, Young Ok; Choe, Yon Ho
- Issue Date
- 3월-2018
- Publisher
- OXFORD UNIV PRESS INC
- Keywords
- biosimilar; children; inflammatory bowel disease; infliximab; switching
- Citation
- INFLAMMATORY BOWEL DISEASES, v.24, no.3, pp.607 - 616
- Indexed
- SCIE
SCOPUS
- Journal Title
- INFLAMMATORY BOWEL DISEASES
- Volume
- 24
- Number
- 3
- Start Page
- 607
- End Page
- 616
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/76827
- DOI
- 10.1093/ibd/izx047
- ISSN
- 1078-0998
- 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.
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Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
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