Assessment of Hearing Dysfunction in Patients With Graves’ Disease and Thyroid Eye Disease Without or With Teprotumumab

CONTEXT: Thyroid eye disease (TED) negatively affects quality of life. TED occurs predominantly in Graves' disease (GD). Teprotumumab improves TED but concern for hearing adverse events (AEs) has emerged. Hearing dysfunction is reported in thyroid autoimmune disease but the background prevalence in GD/TED without teprotumumab remains uncertain. OBJECTIVE: This work aimed to quantify ear-related diagnostic codes/hearing AEs in GD, TED, and patients receiving teprotumumab by examining medical claims and clinical trials. METHODS: Deidentified claims for ear/labyrinth-related International Classification of Disorders, Tenth Revision codes (KOMODO) were examined in GD patients without TED, and TED patients without/with teprotumumab treatment. Hearing AE incidence/severity was evaluated in teprotumumab clinical trials. Graves' Ophthalmopathy Quality of Life questionnaire (GO-QOL) scores were compared in teprotumumab TED trial patients without/with hearing AEs. RESULTS: GD (469 720), TED (38 566) and teprotumumab-treated (967) patients were identified in the claims database. Ear-related codes (including those not specific for hearing) occurred in 24% GD, 33% TED, and 32% teprotumumab-treated patients. "Sensorineural hearing loss bilateral" was most frequent: 7% (32 961/469 720) GD, 11.1% (4279/38 566) TED, and 10.8% (104/967) teprotumumab patients. Before teprotumumab use, 17.1% (165) patients had ear-related codes, while 10.1% (98) had new ear-related codes post treatment.Eight teprotumumab oncology trials revealed 8.1% (51/633) had ear/labyrinth disorders with 2.1% (13) considered study-drug-related and 3.8% (24) hearing impairment/tinnitus-related AEs with 1.3% (8) considered study-drug-related. Similar rates occurred in TED trials.GO-QOL improved in teprotumumab-treated patients without/with hearing AEs. Incidence/severity was consistent across patients with chronic and acute TED. CONCLUSION: These analyses indicate similar prevalence of hearing claims in patients with GD/TED alone as following teprotumumab treatment. Future analyses of incremental hearing risk from teprotumumab should use a priori study designs accounting for background hearing dysfunction in patients with GD/TED.