Gut Liver.
2023 May;17(3):430-440. 10.5009/gnl220005.
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
- Affiliations
-
- 1Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 2Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
- 3Division of Gastroenterology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 4Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.
- 6Medical Science Division, Celltrion, Inc., Incheon, Korea.
- 7Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
- KMID: 2542344
- DOI: http://doi.org/10.5009/gnl220005
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 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.
Keyword
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Current status of biosimilars in the treatment of inflammatory bowel diseases
- Factors Affecting Surgical Treatment With Infliximab Therapy in Perianal Fistula With Crohn Disease
- Recent Trends of Infliximab Treatment for Crohn's Disease
- Adalimumab or infliximab: which is better for perianal fistula in Crohn's disease?
- A Case of Infliximab-induced Psoriasis in Treatment of Ankylosing Spondylitis
