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Infliximab-induced autoantibodies: a multicenter study.

João Luiz Pereira Vaz1, Vander Fernandes2, Felipe Nogueira3

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Clinical Rheumatology
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Summary

Infliximab treatment can lead to the development of autoantibodies like antinuclear antibodies (ANA) and anti-double-stranded DNA (anti-dsDNA), though clinical autoimmune disease is rare. This study tracked autoantibody incidence in patients receiving infliximab for various conditions.

Keywords:
AutoantibodiesBiomarkersDiagnostic testsInfliximabPharmacovigilance

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Area of Science:

  • Immunology
  • Rheumatology
  • Pharmacology

Background:

  • Biologic therapies, including anti-tumor necrosis factor (anti-TNF) agents like infliximab, are widely used for autoimmune and inflammatory diseases.
  • The potential for these therapies to induce autoantibody formation and autoimmune conditions requires careful monitoring.

Purpose of the Study:

  • To assess the incidence of autoantibodies in patients treated with infliximab.
  • To evaluate the development of new autoimmune diseases during infliximab therapy.

Main Methods:

  • A multicenter, longitudinal, open-label, phase IV observational study.
  • Assessed autoantibodies (ANA, anti-Sm, anti-dsDNA, etc.) before and after infliximab treatment in 286 patients with various conditions.
  • Statistical analysis using Fisher exact, Wilcoxon, and McNemar tests.

Main Results:

  • A significant increase in antinuclear antibody (ANA) detection and anti-double-stranded DNA (anti-dsDNA) antibodies was observed post-treatment (p=0.001 and p=0.003, respectively).
  • 186 patients tested positive for ANA after treatment, with a fine speckled nuclear pattern being most common.
  • Only one patient (0.35%) developed drug-induced lupus, which resolved after discontinuing infliximab.

Conclusions:

  • Infliximab treatment can induce autoantibody formation, specifically ANA and anti-dsDNA.
  • These induced autoantibodies generally lack significant clinical manifestations, with a very low incidence of drug-induced lupus.