(0961) Temporal Assessment of Adverse Otologic Outcomes With Teprotumumab for Thyroid Eye Disease

Introduction: The goal of this study is to identify an association of teprotumumab usage for thyroid eye disease (TED) with otologic side effects for patients with short-term and long-term usage in a large database.

Methods: This is a retrospective study that utilized de-identified patient data from the TriNetX database for adult patients who were diagnosed with TED and subsequently prescribed teprotumumab from January 1, 2020 to December 6, 2023. The data are accumulated from 82 health care institutions that participate in data aggregation with TriNetX. The main outcomes that will be evaluated include the relative risk of developing sensorineural hearing loss and tinnitus from 15 days after usage up to 3 years with 95% confidence interval (CI) compared to patients who did not receive teprotumumab.

Results: After propensity score matching, 781 patients treated with teprotumumab were matched to 781 patients treated with standard of care. At day 15, patients who started teprotumumab did not have increased risk of SNHL compared to standard of care (RR: 1.06; 95% CI: 0.44-2.53). At 6 months, the risk of developing SNHL was higher for the group treated with teprotumumab compared to the control (RR: 4.67; 95% CI: 2.37-9.19). At 3 years, the rate of SNHL remained higher for patients treated with teprotumumab (RR: 4.03; 95% CI: 2.49-6.52). Rate of tinnitus was higher as early as 15 days in the group treated with teprotumumab (1.33%) as no patients in the control developed tinnitus (p = 0.0015).

Conclusions: In this large database analysis, there is a high incidence of SNHL and tinnitus associated with teprotumumab usage. There is suggestive ototoxicity of teprotumumab up to 3 years with usage.