Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study
DC Field | Value | Language |
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dc.contributor.author | Kang, Ben | - |
dc.contributor.author | Lee, Yoon | - |
dc.contributor.author | Lee, Kiwuk | - |
dc.contributor.author | Choi, Young Ok | - |
dc.contributor.author | Choe, Yon Ho | - |
dc.date.accessioned | 2021-09-02T14:00:29Z | - |
dc.date.available | 2021-09-02T14:00:29Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2018-03 | - |
dc.identifier.issn | 1078-0998 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/76827 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS INC | - |
dc.subject | BIOSIMILAR INFLIXIMAB CT-P13 | - |
dc.subject | ACTIVE RHEUMATOID-ARTHRITIS | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | INNOVATOR INFLIXIMAB | - |
dc.subject | CROHNS-DISEASE | - |
dc.subject | PARALLEL-GROUP | - |
dc.subject | ANKYLOSING-SPONDYLITIS | - |
dc.subject | ORIGINATOR INFLIXIMAB | - |
dc.subject | POSITION STATEMENT | - |
dc.subject | NOR-SWITCH | - |
dc.title | Long-term Outcomes After Switching to CT-P13 in Pediatric-Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Yoon | - |
dc.identifier.doi | 10.1093/ibd/izx047 | - |
dc.identifier.wosid | 000427537700017 | - |
dc.identifier.bibliographicCitation | INFLAMMATORY BOWEL DISEASES, v.24, no.3, pp.607 - 616 | - |
dc.relation.isPartOf | INFLAMMATORY BOWEL DISEASES | - |
dc.citation.title | INFLAMMATORY BOWEL DISEASES | - |
dc.citation.volume | 24 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 607 | - |
dc.citation.endPage | 616 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | BIOSIMILAR INFLIXIMAB CT-P13 | - |
dc.subject.keywordPlus | ACTIVE RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | INNOVATOR INFLIXIMAB | - |
dc.subject.keywordPlus | CROHNS-DISEASE | - |
dc.subject.keywordPlus | PARALLEL-GROUP | - |
dc.subject.keywordPlus | ANKYLOSING-SPONDYLITIS | - |
dc.subject.keywordPlus | ORIGINATOR INFLIXIMAB | - |
dc.subject.keywordPlus | POSITION STATEMENT | - |
dc.subject.keywordPlus | NOR-SWITCH | - |
dc.subject.keywordAuthor | biosimilar | - |
dc.subject.keywordAuthor | children | - |
dc.subject.keywordAuthor | inflammatory bowel disease | - |
dc.subject.keywordAuthor | infliximab | - |
dc.subject.keywordAuthor | switching | - |
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