title: Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study.
abstract: OBJECTIVE
  The biosimilar of infliximab, CT-P13, has recently been shown to be equivalent to infliximab in both efficacy and safety in the treatment of rheumatologic diseases. However, no data are available with respect to the drug's efficacy in patients with inflammatory bowel disease (IBD). We aimed to assess the efficacy and safety of CT-P13 in IBD patients
  
  
  METHODS
  This was a retrospective multicenter study including both anti-tumor necrosis factor (TNF) naïve patients and patients who switched from the biologic originator to CT-P13.
  
  
  RESULTS
  In anti-TNF naïve Crohn's disease (CD) patients (n = 32), clinical response and remission rates were 90.6% and 68.8% at week 2, 90.6% and 84.4% at week 8, 95.5% and 77.3% at week 30, and 87.5% and 75.0% at week 54, respectively. In anti-TNF naïve ulcerative colitis (UC) patients (n = 42), clinical response and remission rates were 76.2% and 19.0% at week 2, 81.0% and 38.1% at week 8, 91.3% and 47.8% at week 30, and 100% and 50.0% at week 54, respectively, while mucosal healing rates were 58.3% at week 8, 66.7% at week 30, and 66.7% at week 54. The efficacy of CT-P13 was maintained in 92.6% (25/27) of CD patients and in 66.7% (6/9) of UC patients after switching from its originator. Adverse events related to CT-P13 occurred in 11.8% of UC patients.
  
  
  CONCLUSIONS
  CT-P13 appears to have comparable efficacy, safety, and interchangeability with its originator in the treatment of IBD. Further prospective studies with long-term follow-up periods will be needed to confirm the biosimilarity of CT-P13.
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yoon Suk
authors.initials: YS
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Dong Il
authors.initials: DI
authors.lastname: Park
authors.affiliation: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Young Ho
authors.initials: YH
authors.lastname: Kim
authors.affiliation: Digestive Endoscopic Center, Seoul Song Do Colorectal Hospital, Seoul, Korea.
authors.forename: Ji Hyun
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Digestive Endoscopic Center, Seoul Song Do Colorectal Hospital, Seoul, Korea.
authors.forename: Pyoung Ju
authors.initials: PJ
authors.lastname: Seo
authors.affiliation: Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jae Hee
authors.initials: JH
authors.lastname: Cheon
authors.affiliation: Department of Internal Medicine, College of Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
authors.forename: Hyoun Woo
authors.initials: HW
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul, Korea.
authors.forename: Ji Won
authors.initials: JW
authors.lastname: Kim
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D008297:Male; D015337:Multicenter Studies as Topic; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; C000591237:CT-P13; D000069285:Infliximab
keywords: Crohn's disease; biosimilar; infliximab; ulcerative colitis