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Expert Rev Gastroenterol Hepatol. 2015;9 Suppl 1:35-44. doi: 10.1586/17474124.2015.1091309.

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.

Author information

1
a 1 Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
2
b 2 Department of Internal Medicine, Samsung Medical Center, Seoul, Republic of Korea.
3
c 3 Seoul Song Do Colorectal Hospital, Seoul, Republic of Korea.
4
d 4 Digestive Endoscopic Center, Esoo Hospital, Cheonan-si, Republic of Korea.
5
e 5 Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Republic of Korea.
6
f 6 Departments of Clinical Pathology, Internal Medicine, Inha University Medical College, Incheon, Republic of Korea.
7
g 7 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
8
h 8 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
9
i 9 Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
10
j 10 Celltrion, Incheon, Republic of Korea.

Abstract

OBJECTIVE:

To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea.

METHODS:

This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission.

RESULTS:

No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not.

CONCLUSION:

CT-P13 was well tolerated and efficacious in patients with IBD.

KEYWORDS:

CT-P13; Crohn’s disease; South Korea; biosimilar; efficacy; inflammatory bowel disease; infliximab; post-marketing study; safety; switching; ulcerative colitis

PMID:
26395533
DOI:
10.1586/17474124.2015.1091309
[Indexed for MEDLINE]

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