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, JaeHee Cheon, Jong Pil Im, You Sun Kim, Sung Young Lee, Sang Joon Lee

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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 languageEnglish
Pages (from-to)S35-S44
JournalExpert Review of Gastroenterology and Hepatology
Publication statusPublished - 2015 Sep 28


All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Park, S. H., Kim, Y. H., Lee, J. H., Kwon, H. J., Lee, S. H., Park, D. I., Kim, H. K., Cheon, J., Im, J. P., Kim, Y. S., Lee, S. Y., & Lee, S. J. (2015). Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Review of Gastroenterology and Hepatology, 9, S35-S44.