title: Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.
abstract: OBJECTIVE
  Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab. We present the outcomes of a service evaluation of switching IBD patients established on originator infliximab to biosimilar, using a managed switching programme funded via a gain share agreement in a UK teaching hospital.
  
  
  METHODS
  Evaluation outcomes included drug persistence, changes in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes assessed using the IBD-control Patient-Reported Outcome Measures [PROM] questionnaire, serum drug and antibody levels, and routinely collected biochemical markers.
  
  
  RESULTS
  A total of 143 patients with IBD [118 Crohn's disease, 23 ulcerative colitis, 2 IBD unclassified] were switched from originator infliximab to CT-P13. Patients reported a similar incidence of side effects before and after switch. No clinically significant differences were observed in mean C-reactive protein [CRP], albumin, haemoglobin levels, or platelet and white cell counts after the switch to CT-P13, whereas mean IBD-control-8 score improved from 10.4 to 11.2 [p = 0.041]. There was no significant difference in drug persistence between biosimilar and originator infliximab [p = 0.94] and no increase in immunogenicity was found. Drug acquisition costs decreased by £40,000-60,000 per month.
  
  
  CONCLUSIONS
  A managed switching programme from originator infliximab to biosimilar CT-P13 in IBD, using a gain-share agreement, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes, biochemical response, drug persistence, and adverse event profile.
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Violeta
authors.initials: V
authors.lastname: Razanskaite
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Marion
authors.initials: M
authors.lastname: Bettey
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Downey
authors.affiliation: Pharmaceutical Commissioning, West Hampshire CCG, Eastleigh, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Wright
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: James
authors.initials: J
authors.lastname: Callaghan
authors.affiliation: University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Miles
authors.initials: M
authors.lastname: Rush
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Whiteoak
authors.affiliation: Pharmaceutical Commissioning, West Hampshire CCG, Eastleigh, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ker
authors.affiliation: Department of Finance, Southampton General Hospital, Southampton, UK.
authors.forename: Kim
authors.initials: K
authors.lastname: Perry
authors.affiliation: Department of Pharmacy, Southampton General Hospital, Southampton, UK.
authors.forename: Caron
authors.initials: C
authors.lastname: Underhill
authors.affiliation: Department of Allergy and Immunology, Southampton General Hospital, Southampton, UK.
authors.forename: Eren
authors.initials: E
authors.lastname: Efrem
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Iftikar
authors.initials: I
authors.lastname: Ahmed
authors.affiliation: Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
authors.forename: Fraser
authors.initials: F
authors.lastname: Cummings
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000906:Antibodies / Q000097:blood; D000911:Antibodies, Monoclonal / Q000097:blood / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000097:blood / Q000191:economics / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000187:drug effects; D016527:Drug Costs; D057915:Drug Substitution; D005260:Female; D005765:Gastrointestinal Agents / Q000097:blood / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000191:economics / Q000627:therapeutic use*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010976:Platelet Count; D012709:Serum Albumin / Q000187:drug effects; D055815:Young Adult
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D006454:Hemoglobins; D012709:Serum Albumin; D002097:C-Reactive Protein; D000069285:Infliximab
keywords: Inflammatory bowel disease; Infliximab; biosimilar switching; biosimilars; gain share