The risk of hearing changes has been reported in association with teprotumumab (Tepezza) treatment. Patients given teprotumumab may benefit from regular audiometric testing.
Study design
A noncomparative case series evaluated data from 22 patients (44 ears) who were treated with the standard dose of teprotumumab (10 mg/kg for the first infusion, then 20 mg/kg for the subsequent 7 infusions) for thyroid eye disease and had standard audiometric testing (decibel hearing threshold [db HL] at 250 Hz, 500 Hz, 1 kHz, 4 kHz, and 8 kHz) before and after treatment. Some patients also had mid-treatment audiometric testing. Each ear was tracked separately. Pure tone average (PTA) db HL for low, mid, high, and all frequencies were calculated to compare baseline PTA to post-treatment PTA.
Outcomes
The mean patient age at infusion was 52.4 years. Sixteen ears had normal baseline hearing and 28 had baseline hearing loss. Seventeen ears (39%) had post-treatment hearing loss that met ototoxicity criteria: 4 ears with normal baseline hearing and 13 ears with baseline hearing loss. Half of the patients met the criteria for ototoxicity based on their post-treatment hearing loss in at least one ear. In addition, 8 patients reported symptoms of tinnitus, ear fullness, ear popping, hearing loss, autophony, ear pain, and vertigo. Baseline PTA and age were individually predictive of ototoxicity, with baseline PTA being slightly more predictive.
Limitations
The study was unbalanced with respect to gender, as 19 of the 22 patients were women. Post-treatment audiograms occurred at various stages during a relatively long time period (0–496 days).
Clinical significance
Prior to initiation of teprotumumab treatment, patients should be counseled about risk of hearing changes associated with the drug. Pretreatment, mid-treatment, and post-treatment audiographs should be considered for monitoring. Older patients and those with baseline hearing difficulties may benefit from more frequent testing, as they are particularly at risk for hearing changes.
Financial Disclosures: Dr. Nikisha Richards discloses financial relationships with Horizon Therapeutics (Consultant/Advisor).