Ear and labyrinth toxicities induced by immune checkpoint inhibitors: a disproportionality analysis from 2014 to 2019

Immunotherapy. 2020 May;12(7):531-540. doi: 10.2217/imt-2019-0120. Epub 2020 May 27.

Abstract

Aim: We aimed to systematically characterize ear and labyrinth toxicities after immune checkpoint inhibitors (ICIs) initiation. Materials & methods: Data were extracted from the US FDA Adverse Event Reporting System database. Disproportionality analysis including information component and reporting odds ratio (ROR) was performed to access potential signals. Results: In FDA Adverse Event Reporting System database, 284 records for ICIs-associated ear/labyrinth adverse events (AEs) were involved. In general, there was no significant association between total ICIs use and total ear and labyrinth AEs (ROR025: 0.576). However, in ICIs monotherapy and polytherapy groups, signals were detected in several specific ear and labyrinth AEs. Conclusion: Total ear and labyrinth toxicities were not significantly reported with ICI immunotherapy, while class-specific ear toxicities were detected in some strategies.

Keywords: FAERS database; disproportionality analysis; ear and labyrinth toxicities; immune checkpoint inhibitors.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Humans
  • Immune Checkpoint Inhibitors / adverse effects*
  • Immunotherapy / adverse effects
  • Male
  • Ototoxicity / epidemiology
  • Ototoxicity / etiology*
  • United States / epidemiology
  • United States Food and Drug Administration / statistics & numerical data

Substances

  • Immune Checkpoint Inhibitors