title: Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.
abstract: BACKGROUND
  CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD.
  
  
  OBJECTIVE
  To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice.
  
  
  METHODS
  This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy.
  
  
  RESULTS
  87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study.
  
  
  CONCLUSIONS
  CT-P13 was efficacious and well tolerated in patients with CD or UC.
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain. farguelles@telefonica.net.
authors.forename: F
authors.initials: F
authors.lastname: Argüelles-Arias
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: M F
authors.initials: MF
authors.lastname: Guerra Veloz
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Perea Amarillo
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Vilches-Arenas
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Castro Laria
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Maldonado Pérez
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Chaaro
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Benítez Roldán
authors.affiliation: Unidad de Farmacia, Hospital Universitario Virgen Macarena (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Merino
authors.affiliation: Unidad de Farmacia, Hospital Universitario Virgen Macarena (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Ramírez
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Caunedo Álvarez
authors.affiliation: UGC Digestivo Intercentros, Hospitales Universitarios Virgen Macarena-Rocío (Sevilla), Avda Dr. Fedriani 3, 41007, Seville, Spain.|Dirección Gerencia, Hospital Universitario Virgen Rocío (Sevilla), Avda Manuel Siurot, s/n, 41013, Seville, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Romero Gómez
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction
chemical_list: D000911:Antibodies, Monoclonal; C000591237:CT-P13
keywords: Biosimilar agent; CT-P13; Crohn’s disease; Infliximab; Ulcerative colitis