Sang Hyoung Park1, Young-Ho Kim2, Ji Hyun Lee3, Hyeok Jin Kwon3, Suck-Ho Lee4, Dong Il Park5, Hyung Kil Kim6, Jae Hee Cheon7, Jong Pil Im8, You Sun Kim9, Sung Young Lee10, Sang Joon Lee10. 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.
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.