Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars.

Abstract

OBJECTIVES:

The aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13.

METHODS:

250 consecutive patients with rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA assays: Promonitor-ANTI-IFX kit, which uses Remicade to detect antibodies, and two more assays that use either Inflectra or Remsima with the same format. Correlation and association between each assay was studied.

RESULTS:

50.4% of patients were tested positive with Promonitor-ANTI-IFX. All were antibodies to IFX (ATI)-positive when either Inflectra or Remsima assays were used. In all comparisons positive and negative percentage agreements were 100%, and correlation coefficients were ≥0.995. No differences between rheumatoid arthritis and spondyloarthritis, or between concomitant immunosuppressives, were observed.

CONCLUSIONS:

Anti-IFX antibodies of Remicade-treated patients cross-react with either Inflectra or Remsima. Although additional epitopes may be present in the biosimilar, results suggest that epitopes influencing the immune response to IFX are also present in the biosimilar. Antibody-positive patients treated with Remicade should not be switched to the biosimilar, since antibodies will interact with the new drug and potentially lead to loss of response. This finding supports the utility for therapeutic drug monitoring before a switching strategy is considered.

• Authors: M Begoña Ruiz-Argüello, Ainara Maguregui, Ainhoa Ruiz Del Agua, Dora Pascual-Salcedo, Ana Martínez-Feito, Teresa Jurado, Chamaida Plasencia, Alejandro Balsa, Francisca Llinares-Tello, José Rosas, Nerea Torres, Antonio Martínez, Daniel Nagore
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 75 Issue 9 Pg. 1693-6 (09 2016) ISSN: 1468-2060 [Electronic] England
• PMID: 26965981 (Publication Type: Journal Article)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Chemical References

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

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (blood, immunology)
• Antirheumatic Agents (immunology)
• Biosimilar Pharmaceuticals
• Case-Control Studies
• Cross Reactions
• Dose-Response Relationship, Immunologic
• Drug Monitoring
• Drug Substitution
• Enzyme-Linked Immunosorbent Assay
• Female
• Humans
• Infliximab (immunology)
• Male
• Middle Aged
• Retrospective Studies
• Rheumatic Diseases (blood, drug therapy, immunology)
• Young Adult