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Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars
  1. M Begoña Ruiz-Argüello1,
  2. Ainara Maguregui1,
  3. Ainhoa Ruiz del Agua1,
  4. Dora Pascual-Salcedo2,
  5. Ana Martínez-Feito3,
  6. Teresa Jurado4,
  7. Chamaida Plasencia4,
  8. Alejandro Balsa4,
  9. Francisca Llinares-Tello5,
  10. José Rosas6,
  11. Nerea Torres1,
  12. Antonio Martínez1,
  13. Daniel Nagore1
  1. 1R&D Department, Progenika-Grifols, Derio, Spain
  2. 2Immunology Unit, La Paz University Hospital, Madrid, Spain
  3. 3Immunology Unit, La Paz University Hospital-Idipaz, Madrid, Spain
  4. 4Rheumatology Department, La Paz University Hospital, Madrid, Spain
  5. 5Clinical Analysis, Hospital Marina Baixa, Villajoyosa, Spain
  6. 6Rheumatology Department, Hospital Marina Baixa, Villajoyosa, Spain
  1. Correspondence to Dr Daniel Nagore, Progenika-Grifols, 504 Parque Tecnológico Bizkaia, Derio 48160 Spain; daniel.nagore{at}progenika.grifols.com

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.

  • Treatment
  • Rheumatoid Arthritis
  • Anti-TNF
  • Spondyloarthritis

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