85 243

Cited 0 times in

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

DC Field Value Language
dc.contributor.author박지혜-
dc.contributor.author천재희-
dc.date.accessioned2023-03-22T02:12:35Z-
dc.date.available2023-03-22T02:12:35Z-
dc.date.issued2023-05-
dc.identifier.issn1976-2283-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/193546-
dc.description.abstractBackground/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 μg/mL at week 6 and 4.0 μg/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.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherEditorial Office of Gut and Liver-
dc.relation.isPartOfGUT AND LIVER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleEarly 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-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorJihye Park-
dc.contributor.googleauthorJae Hee Cheon-
dc.contributor.googleauthorKang-Moon Lee-
dc.contributor.googleauthorYoung-Ho Kim-
dc.contributor.googleauthorByong Duk Ye-
dc.contributor.googleauthorChang Soo Eun-
dc.contributor.googleauthorSung Hyun Kim-
dc.contributor.googleauthorSun Hee Lee-
dc.contributor.googleauthorJoon Ho Lee-
dc.contributor.googleauthorStefan Schreiber-
dc.identifier.doi10.5009/gnl220005-
dc.contributor.localIdA04575-
dc.contributor.localIdA04030-
dc.relation.journalcodeJ00954-
dc.identifier.eissn2005-1212-
dc.identifier.pmid35975641-
dc.subject.keywordCT-P13-
dc.subject.keywordCrohn disease-
dc.subject.keywordImmunogenicity-
dc.subject.keywordInfliximab trough level-
dc.contributor.alternativeNamePark, Ji Hye-
dc.contributor.affiliatedAuthor박지혜-
dc.contributor.affiliatedAuthor천재희-
dc.citation.volume17-
dc.citation.number3-
dc.citation.startPage430-
dc.citation.endPage440-
dc.identifier.bibliographicCitationGUT AND LIVER, Vol.17(3) : 430-440, 2023-05-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.