Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease

A retrospective multicenter study

Yoon Suk Jung, Dong Il Park, Young Ho Kim, Ji Hyun Lee, Pyoung Ju Seo, JaeHee Cheon, Hyoun Woo Kang, Ji Won Kim

Research output: Contribution to journalArticle

117 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1705-1712
Number of pages8
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume30
Issue number12
DOIs
Publication statusPublished - 2015 Dec 1

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Biosimilar Pharmaceuticals
Inflammatory Bowel Diseases
Multicenter Studies
Retrospective Studies
Safety
Ulcerative Colitis
Tumor Necrosis Factor-alpha
Crohn Disease
CT-P13
Infliximab

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Jung, Yoon Suk ; Park, Dong Il ; Kim, Young Ho ; Lee, Ji Hyun ; Seo, Pyoung Ju ; Cheon, JaeHee ; Kang, Hyoun Woo ; Kim, Ji Won. / Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease : A retrospective multicenter study. In: Journal of Gastroenterology and Hepatology (Australia). 2015 ; Vol. 30, No. 12. pp. 1705-1712.
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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) na{\"i}ve patients and patients who switched from the biologic originator to CT-P13. Results: In anti-TNF na{\"i}ve 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 na{\"i}ve 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.",
author = "Jung, {Yoon Suk} and Park, {Dong Il} and Kim, {Young Ho} and Lee, {Ji Hyun} and Seo, {Pyoung Ju} and JaeHee Cheon and Kang, {Hyoun Woo} and Kim, {Ji Won}",
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Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease : A retrospective multicenter study. / Jung, Yoon Suk; Park, Dong Il; Kim, Young Ho; Lee, Ji Hyun; Seo, Pyoung Ju; Cheon, JaeHee; Kang, Hyoun Woo; Kim, Ji Won.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 30, No. 12, 01.12.2015, p. 1705-1712.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease

T2 - A retrospective multicenter study

AU - Jung, Yoon Suk

AU - Park, Dong Il

AU - Kim, Young Ho

AU - Lee, Ji Hyun

AU - Seo, Pyoung Ju

AU - Cheon, JaeHee

AU - Kang, Hyoun Woo

AU - Kim, Ji Won

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N2 - 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.

AB - 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.

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