A Prospective Study on the Potential of Teprotumumab Ototoxicity: Evidence Based recommendations for Screening and Managing Patients at Risk of Hearing Loss

Abstract

Abstract Background Recent observational case series have reported on the potential ototoxicity of teprotumumab. This study aims to objectively evaluate the incidence of teprotumumab induced ototoxicity in patients with TED, using the gold standard of baseline and post treatment audiometry. Methods In this prospective observational case series, consecutive patients who had been diagnosed with TED and were to receive teprotumumab had audiometry at: baseline, prior to each infusion and at 6 months follow up post treatment. An independent audiologist assessed the audiometry. Further, the incidence and natural history of otologic symptoms was also documented. Results 52 patients were included (43 females, 9 males, mean (SD) age: 49 (13)). On objective testing (audiometry), only 63% patients had normal baseline audiometry. At 6 months follow up, of those with normal baseline audiometry, 1 / 32 (3%) had new onset hearing loss. Of those with abnormal baseline audiometry, 20% had mild hearing dysfunction at 6 months follow up. Overall, 5/52 (10%) of patients had objective hearing loss at 6 months. Following treatment, at 24 weeks, 29% reported subjectively new otologic symptoms. At 6 months, this reduced to 7.7%. A prior history of hearing loss was the main risk factor for hearing dysfunction following treatment with teprotumumab. Conclusions Long term hearing loss in TED patients with normal baseline hearing is rare following treatment with teprotumumab (incidence of 3%). Patients with baseline hearing dysfunction are at greater risk of hearing change and management of the dose and interval between infusions is recommended for this group.