• 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, and Sang Joon Lee.
• a 1 Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
• Expert Rev Gastroenterol Hepatol. 2015 Jan 1; 9 Suppl 1: 35-44.

ObjectiveTo evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea.MethodsThis 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.ResultsNo 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.ConclusionCT-P13 was well tolerated and efficacious in patients with IBD.

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