Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme

J Crohns Colitis. 2017 Jun 1;11(6):690-696. doi: 10.1093/ecco-jcc/jjw216.

Abstract

Background and aims: 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.

Keywords: Inflammatory bowel disease; Infliximab; biosimilar switching; biosimilars; gain share.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies / blood
  • Antibodies, Monoclonal / blood
  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / immunology
  • Antibodies, Monoclonal / therapeutic use*
  • Biosimilar Pharmaceuticals / blood
  • Biosimilar Pharmaceuticals / economics
  • Biosimilar Pharmaceuticals / therapeutic use*
  • C-Reactive Protein / drug effects
  • Drug Costs
  • Drug Substitution*
  • Female
  • Gastrointestinal Agents / blood
  • Gastrointestinal Agents / economics
  • Gastrointestinal Agents / immunology
  • Gastrointestinal Agents / therapeutic use*
  • Hemoglobins / drug effects
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Infliximab / economics
  • Infliximab / therapeutic use*
  • Leukocyte Count
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures
  • Platelet Count
  • Serum Albumin / drug effects
  • Young Adult

Substances

  • Antibodies
  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Gastrointestinal Agents
  • Hemoglobins
  • Serum Albumin
  • C-Reactive Protein
  • Infliximab