A Biologic With Otologic Consequences: Analysis of Hearing Loss and Teprotumumab Using the FDA Adverse Event Reporting System

Abstract

Objectives To evaluate otologic adverse reactions (OARs), including hearing loss (OARs-HL) among patients taking teprotumumab, a new biologic approved for the treatment of active thyroid eye disease, using publicly available pharmacovigilance reporting data. Study Design Retrospective database review Methods The Food and Drug Administration Adverse Events Reporting System (FAERS) was queried for cases involving teprotumumab from 2020Q1 to 2023Q1. Patient demographics and adverse reactions (OAR and OAR-HL) were evaluated. Logistic regression was used to predict OAR and OAR-HL, and disproportionality analysis was performed using OpenVigil. Results A total of 2,109 teprotumumab-AR cases were reported, of which 296 (14.05%; mean age 55.46 yr) were OARs. Of these, 149 (7.06%) reported OAR-HL and 194 (9.20%) reported other OAR (e.g., tinnitus, ear discomfort, vertigo), with 47 (2.23%) reporting both. Disproportionality analysis showed a reported odds ratio (ROR) for OARs-HL of 44.33 (95% confidence interval [CI], 37.40–52.55; p < 0.001). Age was associated with RORs of 1.02 (95% CI, 1.01–1.04) and 1.04 (95% CI, 1.02–1.07) for developing OARs and specifically OARs-HL, respectively (p < 0.01). Age 50 and 65 years and older were associated with RORs of 2.54 (95% CI, 1.16–6.38) and 3.36 (95% CI, 1.75–6.53), respectively, for OARs-HL (p < 0.05). Conclusion This study using FAERS data suggests an increased risk of OARs, specifically hearing loss, associated with teprotumumab. Increasing age was a significant predictor of OARs. Audiometric counseling and evaluation should be considered with teprotumumab therapy in Graves' orbitopathy patients, especially in older patients.