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Long-term effectiveness and pharmacokinetics of the infliximab biosimilar CT-P13 after switching from the originator during the treatment of inflammatory bowel disease
  1. Nerea Martín-Gutiérrez1,
  2. José Germán Sánchez-Hernández1,2,
  3. Noemí Rebollo1,2,
  4. Alejandra F Pordomingo2,3,
  5. Fernando Muñoz2,3,
  6. María José Otero1,2
  1. 1Pharmacy Service, University Hospital of Salamanca, Salamanca, Spain
  2. 2Biomedical Research Institute of Salamanca, Salamanca, Salamanca, Spain
  3. 3Gastroenterology Service, University Hospital of Salamanca, Salamanca, Salamanca, Spain
  1. Correspondence to Dr José Germán Sánchez-Hernández, Pharmacy Service, University Hospital of Salamanca, Salamanca 37007, Spain; jgermansh{at}gmail.com

Abstract

Objective Switching patients from the originator infliximab to a biosimilar is a measure to expand access to treatments and counteract its negative impact on healthcare budgets. However, industry-independent long-term studies on the effect of switching in real life to support the lack of switch-related problems in inflammatory bowel disease (IBD) patients are sparse, as are studies addressing infliximab pharmacokinetic behaviour. The objectives were to investigate the effectiveness and the pharmacokinetics of CT-P13 after switching from originator infliximab in a real-world population of IBD patients with a follow-up of 2 years.

Method Prospective, single-centre, observational 2 year study conducted in IBD adult patients with stable disease treated with the originator infliximab who were switched to CT-P13. Four time points were defined for follow-up: prior to the switch, 4–8 weeks after the switch, 8 months later, and 2 years later. Outcome measures were the proportion of patients with clinical, endoscopic and biochemical remission, and changes in biochemical inflammation markers (albumin, C-reactive protein, faecal calprotectin) and infliximab clearance.

Results 42 IBD patients were switched, of which 36 (85.7%) remained on CT-P13 throughout the 2 year study period. Only two patients discontinued CT-P13 due to loss of response. The proportion of patients who displayed clinical, endoscopic and biochemical remission were unchanged during the follow-up (p<0.05) and no statistically significant changes were observed in the biochemical markers of disease activity. The median (IQR) clearance estimated for the infliximab originator before the change was 0.364 (0.321–0.415) L/day, and for the CT-P13 biosimilar it was 0.361 (0.323–0.415) L/day 4–8 weeks after the change, and 0.370 (0.334–0.419) L/day 2 years after (p=0.395).

Conclusion Switching from originator infliximab to biosimilar CT-P13 did not affect the long-term clinical outcomes or the pharmacokinetic behaviour. This information provides the clinician more evidence for the success of switching and supports non-medical switching in adult IBD patients.

  • inflammatory bowel diseases
  • drug monitoring
  • evidence-based medicine
  • pharmacy service
  • hospital
  • digestive system Diseases
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