title: Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.
abstract: OBJECTIVE
  Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking.
  
  
  METHODS
  A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay.
  
  
  RESULTS
  In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively.
  
  
  CONCLUSIONS
  This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.
authors.affiliation: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Krisztina B
authors.initials: KB
authors.lastname: Gecse
authors.affiliation: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Barbara D
authors.initials: BD
authors.lastname: Lovász
authors.affiliation: First Department of Internal Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Klaudia
authors.initials: K
authors.lastname: Farkas
authors.affiliation: Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
authors.forename: János
authors.initials: J
authors.lastname: Banai
authors.affiliation: First Department of Medicine, Peterfy Hospital, Budapest, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Bene
authors.affiliation: Second Department of Medicine, Zala County Hospital, Zalaegerszeg, Hungary.
authors.forename: Beáta
authors.initials: B
authors.lastname: Gasztonyi
authors.affiliation: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Petra Anna
authors.initials: PA
authors.lastname: Golovics
authors.affiliation: Second Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary.
authors.forename: Tünde
authors.initials: T
authors.lastname: Kristóf
authors.affiliation: Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprém, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Lakatos
authors.affiliation: Second Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Ágnes Anna
authors.initials: ÁA
authors.lastname: Csontos
authors.affiliation: Second Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Márk
authors.initials: M
authors.lastname: Juhász
authors.affiliation: First Department of Internal Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Ferenc
authors.initials: F
authors.lastname: Nagy
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Hungary.
authors.forename: Károly
authors.initials: K
authors.lastname: Palatka
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Hungary.
authors.forename: Mária
authors.initials: M
authors.lastname: Papp
authors.affiliation: Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary.
authors.forename: Árpád
authors.initials: Á
authors.lastname: Patai
authors.affiliation: Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary.
authors.forename: Lilla
authors.initials: L
authors.lastname: Lakner
authors.affiliation: Department of Gastroenterology, Tolna County Teaching Hospital, Szekszárd, Hungary.
authors.forename: Ágnes
authors.initials: Á
authors.lastname: Salamon
authors.affiliation: Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
authors.forename: Tamás
authors.initials: T
authors.lastname: Szamosi
authors.affiliation: First Department of Internal Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Szepes
authors.affiliation: Department of Gastroenterology, Janos Hospital, Budapest, Hungary.
authors.forename: Gábor T
authors.initials: GT
authors.lastname: Tóth
authors.affiliation: First Department of Medicine, University of Pécs, Pécs, Hungary.
authors.forename: Áron
authors.initials: Á
authors.lastname: Vincze
authors.affiliation: Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Balázs
authors.initials: B
authors.lastname: Szalay
authors.affiliation: First Department of Internal Medicine, University of Szeged, Szeged, Hungary.
authors.forename: Tamás
authors.initials: T
authors.lastname: Molnár
authors.affiliation: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary lakatos.peter_laszlo@med.semmelweis-univ.hu.
authors.forename: Péter L
authors.initials: PL
authors.lastname: Lakatos
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D000069285:Infliximab
keywords: Biosimilar; CT-P13; Crohn’s disease; efficacy; immunogenicity; inflammatory bowel diseases; infliximab; safety; ulcerative colitis