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 bropen access
- Authors
- Park, Jihye; Cheon, Jae Hee; Lee, Kang-Moon; Kim, Young-Ho; Ye, Byong Duk; Eun, Chang Soo; Kim, Sung Hyun; Lee, Sun Hee; Lee, Joon Ho; Schreiber, Stefan
- Issue Date
- May-2023
- Publisher
- EDITORIAL OFFICE GUT & LIVER
- Keywords
- CT-P13; Crohn disease; Infliximab trough level; Immunogenicity
- Citation
- GUT AND LIVER, v.17, no.3, pp.1 - 11
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- GUT AND LIVER
- Volume
- 17
- Number
- 3
- Start Page
- 1
- End Page
- 11
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/190537
- DOI
- 10.5009/gnl220005
- ISSN
- 1976-2283
- 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.
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