Early Infliximab Trough Levels Predict the Long-term Efficacy of Infliximab in a Randomized Controlled Trial in Patients with Active Crohn?s Disease Comparing, between CT-P13 and Originator Infliximab br
DC Field | Value | Language |
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dc.contributor.author | Park, Jihye | - |
dc.contributor.author | Cheon, Jae Hee | - |
dc.contributor.author | Lee, Kang-Moon | - |
dc.contributor.author | Kim, Young-Ho | - |
dc.contributor.author | Ye, Byong Duk | - |
dc.contributor.author | Eun, Chang Soo | - |
dc.contributor.author | Kim, Sung Hyun | - |
dc.contributor.author | Lee, Sun Hee | - |
dc.contributor.author | Lee, Joon Ho | - |
dc.contributor.author | Schreiber, Stefan | - |
dc.date.accessioned | 2023-09-18T06:19:29Z | - |
dc.date.available | 2023-09-18T06:19:29Z | - |
dc.date.created | 2022-09-08 | - |
dc.date.issued | 2023-05 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/190537 | - |
dc.description.abstract | Background/Aims: The clinical efficacy and safety of CT-P13 are comparable to originator infliximab for Crohn's disease in CT-P13 3.4 study (NCT02096861). We performed a multivariate logistic analysis to demonstrate the association between early infliximab trough levels and treatment outcomes of CT-P13 and originator infliximab. Methods: Early serum infliximab trough levels and anti-drug antibody (ADA) levels were compared between CT-P13 (n=100) and originator infliximab (n=98) groups. Receiver operating characteristic (ROC) analysis and multivariate logistic analysis were conducted to identify optimal cutoffs of serum infliximab trough levels and predictive factors for clinical outcomes. Results: The median infliximab trough levels were not different between CT-P13 and originator infliximab groups at week 6, week 14, and in median ADA levels at week 14, respectively. ROC analysis found an infliximab concentration threshold of 4.5 mu g/mL at week 6 and 4.0 mu g/mL at week 14 as the cutoff value with the highest accuracy for the prediction of clinical outcomes. Serum infliximab trough levels at weeks 6 and 14 predicted clinical remission at weeks 30 and 54, and endoscopic remission at week 54. The combinations of clinical remission or C-reactive protein normalization with an early infliximab trough level improved the prediction of long-term clinical or endoscopic remission. Conclusions: A threshold in serum infliximab trough level at week 6 and week 14 was highly predictive for long-term clinical outcomes. There were no statistical differences in serum infliximab trough levels and ADA levels between CT-P13 and originator infliximab. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | EDITORIAL OFFICE GUT & LIVER | - |
dc.title | Early Infliximab Trough Levels Predict the Long-term Efficacy of Infliximab in a Randomized Controlled Trial in Patients with Active Crohn?s Disease Comparing, between CT-P13 and Originator Infliximab br | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Eun, Chang Soo | - |
dc.identifier.doi | 10.5009/gnl220005 | - |
dc.identifier.scopusid | 2-s2.0-85159732246 | - |
dc.identifier.wosid | 000842123300001 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, v.17, no.3, pp.1 - 11 | - |
dc.relation.isPartOf | GUT AND LIVER | - |
dc.citation.title | GUT AND LIVER | - |
dc.citation.volume | 17 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 11 | - |
dc.type.rims | ART | - |
dc.type.docType | Article; Early Access | - |
dc.identifier.kciid | ART002959031 | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | INFLAMMATORY-BOWEL-DISEASE | - |
dc.subject.keywordPlus | ANTIBODY-LEVELS | - |
dc.subject.keywordPlus | DRUG | - |
dc.subject.keywordPlus | IMMUNOGENICITY | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | ASSOCIATION | - |
dc.subject.keywordPlus | REMISSION | - |
dc.subject.keywordAuthor | CT-P13 | - |
dc.subject.keywordAuthor | Crohn disease | - |
dc.subject.keywordAuthor | Infliximab trough level | - |
dc.subject.keywordAuthor | Immunogenicity | - |
dc.identifier.url | https://www.gutnliver.org/journal/view.html?doi=10.5009/gnl220005 | - |
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