Patients' perspectives after switching from infliximab to biosimilar CT-P13 in patients with inflammatory bowel disease: A 12-month prospective cohort study

Dig Liver Dis. 2019 Dec;51(12):1652-1660. doi: 10.1016/j.dld.2019.08.020. Epub 2019 Nov 11.

Abstract

Background: Patients' perspectives after switching from infliximab to a biosimilar have yet to be assessed.

Aim: To assess patients' perspectives in a prospective manner after switching from infliximab to CT-P13.

Methods: 113 consecutive patients with inflammatory bowel disease (IBD) on maintenance therapy with infliximab were switched to CT-P13. Patients' perspectives were assessed by questionnaires, including the Beliefs about Medicines Questionnaire (BMQ) and FACIT-F (questionnaire regarding fatigue), and patient-reported outcomes (IBD disability index) at the inclusion and after the fourth CT-P13 infusion.

Results: After one year, the patients' perspectives did not change after the switch according to BMQ-general, BMQ-specific necessity and BMQ-specific concerns subscales. No difference was observed in the mean IBD-DI score, while a significant improvement in fatigue was observed according to the FACIT-F questionnaire. Patients' concerns were raised about the use of biosimilars and the risks of switching with a significant improvement after switching (65% vs. 42%, respectively, p = 0.01). Fourteen (12.4%) patients experienced loss of response to CT-P13, including 12 with restoration of steroid-free clinical remission after CT-P13 dose optimization.

Conclusion: Although some concerns were reported, no difference was observed in patients' perspectives after switching from infliximab to CT-P13.

Keywords: Biosimilar; CT-P13; Crohn’s disease; Inflammatory bowel disease; Infliximab; Ulcerative colitis.

MeSH terms

  • Adult
  • Antibodies, Monoclonal* / administration & dosage
  • Antibodies, Monoclonal* / adverse effects
  • Biosimilar Pharmaceuticals* / administration & dosage
  • Biosimilar Pharmaceuticals* / adverse effects
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / epidemiology
  • Crohn Disease / drug therapy*
  • Crohn Disease / epidemiology
  • Drug Monitoring / methods
  • Drug Substitution / methods
  • Drug Substitution / psychology
  • Female
  • France / epidemiology
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Infliximab* / administration & dosage
  • Infliximab* / adverse effects
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures
  • Prospective Studies
  • Remission Induction / methods

Substances

  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Gastrointestinal Agents
  • Infliximab