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J Gastroenterol Hepatol. 2015 Dec;30(12):1705-12. doi: 10.1111/jgh.12997.

Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study.

Author information

1
Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
2
Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
3
Digestive Endoscopic Center, Seoul Song Do Colorectal Hospital, Seoul, Korea.
4
Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
5
Department of Internal Medicine, College of Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
6
Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul, Korea.

Abstract

BACKGROUND AND AIM:

The biosimilar of infliximab, CT-P13, has recently been shown to be equivalent to infliximab in both efficacy and safety in the treatment of rheumatologic diseases. However, no data are available with respect to the drug's efficacy in patients with inflammatory bowel disease (IBD). We aimed to assess the efficacy and safety of CT-P13 in IBD patients

METHODS:

This was a retrospective multicenter study including both anti-tumor necrosis factor (TNF) naïve patients and patients who switched from the biologic originator to CT-P13.

RESULTS:

In anti-TNF naïve Crohn's disease (CD) patients (n = 32), clinical response and remission rates were 90.6% and 68.8% at week 2, 90.6% and 84.4% at week 8, 95.5% and 77.3% at week 30, and 87.5% and 75.0% at week 54, respectively. In anti-TNF naïve ulcerative colitis (UC) patients (n = 42), clinical response and remission rates were 76.2% and 19.0% at week 2, 81.0% and 38.1% at week 8, 91.3% and 47.8% at week 30, and 100% and 50.0% at week 54, respectively, while mucosal healing rates were 58.3% at week 8, 66.7% at week 30, and 66.7% at week 54. The efficacy of CT-P13 was maintained in 92.6% (25/27) of CD patients and in 66.7% (6/9) of UC patients after switching from its originator. Adverse events related to CT-P13 occurred in 11.8% of UC patients.

CONCLUSIONS:

CT-P13 appears to have comparable efficacy, safety, and interchangeability with its originator in the treatment of IBD. Further prospective studies with long-term follow-up periods will be needed to confirm the biosimilarity of CT-P13.

KEYWORDS:

Crohn's disease; biosimilar; infliximab; ulcerative colitis

PMID:
25974251
DOI:
10.1111/jgh.12997
[Indexed for MEDLINE]

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