title: Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study.
abstract: OBJECTIVE
  To assess the efficacy, tolerability, and safety of CT-P13 (Remsima(®)) in patients with Crohn's disease (CD) or ulcerative colitis (UC).
  
  
  METHODS
  This was a prospective observational study performed in a single center in Norway. Patients with CD (n = 46) or UC (n = 32) received CT-P13 (5 mg/kg) by intravenous infusion at weeks 0, 2, and 6. Efficacy end points included remission at week 14, measured by a Harvey-Bradshaw Index score of ≤4 or partial Mayo score of ≤2. Levels of the inflammatory markers C-reactive protein and calprotectin were measured. Adverse events up to week 14 were also recorded.
  
  
  RESULTS
  Seventy-nine percent of CD and 56% of UC patients achieved remission at week 14. Significant reductions in C-reactive protein and calprotectin occurred between baseline and week 14. There were no unexpected adverse events reported during the study.
  
  
  CONCLUSIONS
  CT-P13 is efficacious and well tolerated in patients with CD or UC.
authors.affiliation: a 1 Akershus University Hospital, Lørenskog, Norway.|b 2 Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
authors.forename: Jørgen
authors.initials: J
authors.lastname: Jahnsen
authors.affiliation: a 1 Akershus University Hospital, Lørenskog, Norway.
authors.forename: Trond Espen
authors.initials: TE
authors.lastname: Detlie
authors.affiliation: a 1 Akershus University Hospital, Lørenskog, Norway.
authors.forename: Simen
authors.initials: S
authors.lastname: Vatn
authors.affiliation: a 1 Akershus University Hospital, Lørenskog, Norway.
authors.forename: Petr
authors.initials: P
authors.lastname: Ricanek
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / 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; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009664:Norway; D011446:Prospective Studies; D012074:Remission Induction; 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; Norway; biosimilar; efficacy; inflammatory bowel disease; infliximab; safety; ulcerative colitis