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(®)) 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.
  
  
  CONCLUSIONS
  CT-P13 was well tolerated and efficacious in patients with IBD.
authors.affiliation: a 1 Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Sang Hyoung
authors.initials: SH
authors.lastname: Park
authors.affiliation: b 2 Department of Internal Medicine, Samsung Medical Center, Seoul, Republic of Korea.
authors.forename: Young-Ho
authors.initials: YH
authors.lastname: Kim
authors.affiliation: c 3 Seoul Song Do Colorectal Hospital, Seoul, Republic of Korea.
authors.forename: Ji Hyun
authors.initials: JH
authors.lastname: Lee
authors.affiliation: c 3 Seoul Song Do Colorectal Hospital, Seoul, Republic of Korea.
authors.forename: Hyeok Jin
authors.initials: HJ
authors.lastname: Kwon
authors.affiliation: d 4 Digestive Endoscopic Center, Esoo Hospital, Cheonan-si, Republic of Korea.
authors.forename: Suck-Ho
authors.initials: SH
authors.lastname: Lee
authors.affiliation: e 5 Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Republic of Korea.
authors.forename: Dong Il
authors.initials: DI
authors.lastname: Park
authors.affiliation: f 6 Departments of Clinical Pathology, Internal Medicine, Inha University Medical College, Incheon, Republic of Korea.
authors.forename: Hyung Kil
authors.initials: HK
authors.lastname: Kim
authors.affiliation: g 7 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jae Hee
authors.initials: JH
authors.lastname: Cheon
authors.affiliation: h 8 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jong Pil
authors.initials: JP
authors.lastname: Im
authors.affiliation: i 9 Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
authors.forename: You Sun
authors.initials: YS
authors.lastname: Kim
authors.affiliation: j 10 Celltrion, Incheon, Republic of Korea.
authors.forename: Sung Young
authors.initials: SY
authors.lastname: Lee
authors.affiliation: j 10 Celltrion, Incheon, Republic of Korea.
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012074:Remission Induction; D056910:Republic of Korea; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: CT-P13; Crohn’s disease; South Korea; biosimilar; efficacy; inflammatory bowel disease; infliximab; post-marketing study; safety; switching; ulcerative colitis