Evaluating Efficacy, Safety, and Pharmacokinetics After Switching From Infliximab Originator to Biosimilar CT-P13: Experience From a Large Tertiary Referral Center.

Abstract

BACKGROUND:

The use of infliximab biosimilar CT-P13 has increased in patients with inflammatory bowel disease. Nevertheless, doubts about switching from infliximab originator to biosimilar still exist among patients and health care professionals.

METHODS:

Our tertiary referral center underwent a mandatory switch from infliximab originator to CT-P13 in 2017. We investigated pharmacokinetics, efficacy, and safety of this switch. The primary endpoint was infliximab discontinuation within 6 months of switching. Secondary endpoints included loss of clinical remission, need for treatment optimization, adverse events, evolution of patient-reported outcome, C-reactive protein, infliximab trough levels, and antidrug-antibodies.

RESULTS:

A total of 361 patients (54.0% male, 70.0% Crohn's disease, 55.6% in clinical remission) were enrolled. Infliximab discontinuation within 6 months was observed in 4%. Loss of clinical remission, adverse events, and antidrug-antibodies were identified in only 2.0%, 2.2%, and 1.1% of patients, respectively. C-reactive protein concentrations and infliximab trough levels remained stable. Independent factors associated with remission at 6 months were lower PRO2 at switch (HR 6.024; 95% CI, 4.878-8.000; P < 0.0001) and higher hemoglobin levels (HR 1.383; 95% CI, 1.044-2.299; P = 0.018).

CONCLUSIONS:

Switching from infliximab originator to CT-P13 was not associated with an increased risk of treatment discontinuation, loss of clinical remission, or adverse events. No significant changes in infliximab trough levels or immunogenicity could be identified.

• Authors: Michiel Bronswijk, Annick Moens, Matthias Lenfant, Sophie Tops, Griet Compernolle, Gert Van Assche, Séverine Vermeire, Ann Gils, Marc Ferrante
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 26 Issue 4 Pg. 628-634 (03 04 2020) ISSN: 1536-4844 [Electronic] England
• PMID: 31400283 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

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

Topics

• Adult
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Biosimilar Pharmaceuticals (adverse effects, therapeutic use)
• Colitis, Ulcerative (blood, drug therapy)
• Crohn Disease (blood, drug therapy)
• Female
• Humans
• Infliximab (blood, pharmacokinetics, therapeutic use)
• Male
• Middle Aged
• Patient Reported Outcome Measures
• Prospective Studies
• Remission Induction
• Tertiary Care Centers