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

Sang Hyoung Park; Young Ho Kim; Ji Hyun Lee; Hyeok Jin Kwon; Suck Ho Lee; Dong Il Park; Hyung Kil Kim; Jae Hee Cheon; Jong Pil Im; You Sun Kim; Sung Young Lee; Sang Joon Lee

doi:10.1586/17474124.2015.1091309

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

Sang Hyoung Park, Young Ho Kim, Ji Hyun Lee, Hyeok Jin Kwon, Suck Ho Lee, Dong Il Park, Hyung Kil Kim, Jae Hee Cheon, Jong Pil Im, You Sun Kim, Sung Young Lee, Sang Joon Lee

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

97 Citations (Scopus)

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.

Original language	English
Pages (from-to)	35-44
Number of pages	10
Journal	Expert Review of Gastroenterology and Hepatology
Volume	9
DOIs	https://doi.org/10.1586/17474124.2015.1091309
Publication status	Published - 2015 Sept 28

Bibliographical note

Funding Information:
The study was sponsored by Celltrion. Y Kim, JH Lee, HJ Kwon, S Lee, D Park, HK Kim, JH Cheon, JP Im, and YS Kim have all received financial support for research from Celltrion, Inc., SY Lee and SJ Lee are employees of Celltrion Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing) was provided by Mark O’ Connor (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

Publisher Copyright:
© 2015 © Informa UK, Ltd.

All Science Journal Classification (ASJC) codes

Hepatology
Gastroenterology

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10.1586/17474124.2015.1091309

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@article{da3a4595028e478b9abe46b8252f073f,

title = "Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea",

abstract = "Objective: To evaluate the safety and efficacy of CT-P13 (Remsima{\textregistered}) 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.",

author = "Park, {Sang Hyoung} and Kim, {Young Ho} and Lee, {Ji Hyun} and Kwon, {Hyeok Jin} and Lee, {Suck Ho} and Park, {Dong Il} and Kim, {Hyung Kil} and Cheon, {Jae Hee} and Im, {Jong Pil} and Kim, {You Sun} and Lee, {Sung Young} and Lee, {Sang Joon}",

note = "Funding Information: The study was sponsored by Celltrion. Y Kim, JH Lee, HJ Kwon, S Lee, D Park, HK Kim, JH Cheon, JP Im, and YS Kim have all received financial support for research from Celltrion, Inc., SY Lee and SJ Lee are employees of Celltrion Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing) was provided by Mark O{\textquoteright} Connor (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Publisher Copyright: {\textcopyright} 2015 {\textcopyright} Informa UK, Ltd.",

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doi = "10.1586/17474124.2015.1091309",

language = "English",

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T1 - Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea

AU - Park, Sang Hyoung

AU - Kim, Young Ho

AU - Lee, Ji Hyun

AU - Kwon, Hyeok Jin

AU - Lee, Suck Ho

AU - Park, Dong Il

AU - Kim, Hyung Kil

AU - Cheon, Jae Hee

AU - Im, Jong Pil

AU - Kim, You Sun

AU - Lee, Sung Young

AU - Lee, Sang Joon

N1 - Funding Information: The study was sponsored by Celltrion. Y Kim, JH Lee, HJ Kwon, S Lee, D Park, HK Kim, JH Cheon, JP Im, and YS Kim have all received financial support for research from Celltrion, Inc., SY Lee and SJ Lee are employees of Celltrion Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing) was provided by Mark O’ Connor (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Publisher Copyright: © 2015 © Informa UK, Ltd.

PY - 2015/9/28

Y1 - 2015/9/28

N2 - 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.

AB - 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.

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ER -

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

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

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