Abstract

PURPOSE: To characterize the frequency, severity and resolution of hearing dysfunction in patients treated with teprotumumab for thyroid eye disease (TED).DESIGN: Prospective observational case series.METHODS: Ophthalmic examination and adverse event assessment, including otologic symptoms, were performed at baseline, after infusions 2, 4, and 8, and at 6-month follow-up in consecutive patients who received at least 4 teprotumumab infusions. Labs were collected at baseline and during treatment. Audiometry, patulous Eustachian tube (PET) testing and otolaryngology evaluation were obtained for patients with new or worsening otologic symptoms, with a subset obtaining baseline and post-treatment testing.RESULTS: Twenty-seven patients were analyzed (24 females, 3 males, average 56.3-years-old). Twenty-two patients (81.5%) developed new subjective otologic symptoms, after a mean of 3.8 infusions (SD 1.8). At 39.2 week average follow-up after the last infusion, most patients with tinnitus (100%), ear plugging/fullness (90.9%), and autophony (83.3%) experienced symptom resolution, while only 45.5% (5 of 11) of patients with subjective hearing loss/decreased word comprehension experienced resolution. Six patients underwent baseline and post-treatment audiometry, 5 of whom developed teprotumumab-related sensorineural hearing loss (SNHL) and one patient also developed PET. Three of the 5 patients with teprotumumab-related SNHL had persistent subjective hearing loss at last follow-up. A prior history of hearing loss was discovered as a risk factor for teprotumumab-related SNHL (p=0.008).CONCLUSIONS: Hearing loss is a concerning adverse event of teprotumumab and its mechanism and reversibility should be further studied. Until risk factors for hearing loss are better understood, we recommend baseline audiometry with PET testing and repeat testing if new otologic symptoms develop. Screening, monitoring and prevention guidelines are needed.

View details for DOI 10.1016/j.ajo.2022.02.015

View details for PubMedID 35227694