title: Switching from Remicade® to Remsima® is well Tolerated and Feasible: A Prospective, Open-label Study.
abstract: OBJECTIVE
  A biosimilar version of infliximab [CT-P13/Remsima®] recently entered the European market. The clinical data on its use in inflammatory bowel disease [IBD] are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population.
  
  
  METHODS
  All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima. The follow-up lasted for 6 months. In addition, a retrospective registration was performed with a start time of 6 months before switching drugs. The primary endpoints were [i] the proportion of patients remaining on medication 6 months after switching and [ii] adverse events during the 6 months after switching. The secondary endpoints included [i] disease activity scores [Harvey-Bradshaw Index and Partial Mayo Score], C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval, and p-infliximab and [ii] the development of antidrug antibodies.
  
  
  RESULTS
  In total, 143 IBD patients were switched, 99 with Crohn's disease and 44 with ulcerative colitis. The large majority [97%] remained on the medication throughout follow-up. A low number of adverse events were observed. No change in disease activity, C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval or p-infliximab was detected. Three patients developed new detectable antidrug antibodies.
  
  
  CONCLUSIONS
  Switching from Remicade to Remsima was feasible and with few adverse events, including very limited antidrug antibody formation and loss of response.
authors.affiliation: Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.|Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: Lydia C T
authors.initials: LC
authors.lastname: Buer
authors.affiliation: Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.|Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: Bjørn A
authors.initials: BA
authors.lastname: Moum
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Milada
authors.initials: M
authors.lastname: Cvancarova
authors.affiliation: Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
authors.forename: David J
authors.initials: DJ
authors.lastname: Warren
authors.affiliation: Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.
authors.forename: Asle W
authors.initials: AW
authors.lastname: Medhus
authors.affiliation: Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.
authors.forename: Marte Lie
authors.initials: ML
authors.lastname: Høivik
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000906:Antibodies / Q000097:blood; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D057915:Drug Substitution; D005240:Feasibility Studies; D005243:Feces / Q000737:chemistry; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D006454:Hemoglobins; D039841:Leukocyte L1 Antigen Complex; D002097:C-Reactive Protein; D000069285:Infliximab
keywords: Inflammatory bowel disease; biosimilar; immunogenicity; infliximab; switching