SAT461 Hearing-related Issues Associated With Graves’ Disease, Thyroid Eye Disease And Treatment With Teprotumumab

Disclosure: T.J. Smith: Consulting Fee; Self; Horizon Therapeutics plc, Viridian, Lundbeck. Other; Self; US patents covering the use of IGF-1 receptor inhibitors in TED which are held by UCLA and the Lundquist Institute. A. Qashqai: Employee; Self; Horizon Therapeutics plc. Stock Owner; Self; Horizon Therapeutics plc. N. Barretto: Employee; Self; Horizon Therapeutics plc. Stock Owner; Self; Horizon Therapeutics plc. R.J. Holt: Employee; Self; Horizon Therapeutics plc. Stock Owner; Self; Horizon Therapeutics plc. Background: Thyroid eye disease (TED) can manifest proptosis, diplopia and inflammation. TED may occur in up to 50% of patients (pts) with Graves’ disease (GD); ∼90% of TED pts have hyperthyroidism/GD. Teprotumumab, an insulin-like growth factor-I receptor inhibitory antibody, significantly improves TED symptoms. Hearing-related AEs have been reported in ∼10% of pts receiving teprotumumab in trials. Although hearing loss has been observed with GD,(1) the prevalence is unclear with no independent/cumulative risk data in pts with TED and pts receiving teprotumumab. To estimate background rates of hearing-related changes, we examined hearing-related claims data in pts with GD, TED, and those receiving teprotumumab. Methods: Deidentified closed claims data from the KOMODO database were examined for hearing codes (including hearing loss/ototoxicity and screening-related) in 3 cohorts: GD pts (GD diagnosis [dx] code), TED pts (GD dx and eye symptoms within 1 yr) and teprotumumab/GD pts (≥1 claim for teprotumumab). TED pts were excluded from the GD cohort and teprotumumab pts from the GD/TED cohorts. Included pts were in the database for ≥1 yr pre and 6 months post TED/GD dx/first teprotumumab infusion (09/30/15 to 08/05/22). Results: 469,720 GD pts, 38,566 TED pts and 967 teprotumumab pts were identified. 73-76% were female, with mean age ranging from 52-54 yrs. A significant proportion of GD and TED pts had hearing codes. Among GD pts, 113,268 (24%) had hearing codes; 62,526 (13%) had hearing loss/ototoxicity codes and 67,248 (14%) had screening codes. Among TED pts, 12,807 (33%) had hearing codes; 7,662 (20%) had hearing loss/ototoxicity codes and 8,033 (21%) had screening codes. An increase in hearing codes and screening codes was observed at GD/TED dx. The most frequent code was “sensorineural hearing loss, bilateral” (SNHL), in 32,961/113,268 (29%) of GD pts and 4,279/12,807 (33%) of TED pts with hearing codes. Of 967 teprotumumab pts, 308 (32%) had hearing codes; 172 (18%) had hearing loss/ototoxicity codes and 198 (20%) had screening codes. 210/308 pts (68%) had hearing codes before the first infusion and 98 (32%) had new hearing codes after. The most frequent code (104/308, 34%) was SNHL. Conclusions: Studies in GD pts have suggested decreased hearing ability especially at high frequencies, with mild-moderate SNHL noted in 23.5% of pts.(1,2) We observed a similar rate of hearing-related claims in TED pts with GD, with SNHL being most frequently reported. Therefore, it is important to assess the history of hearing-related issues in pts with thyroid autoimmunity before ascribing hearing-related changes in those treated with teprotumumab. Further, well-controlled research is needed to document incrementally increased risk of hearing-related AEs in pts with TED who receive teprotumumab. References: (1)Berker D, et al. Endocrine. 2012; 41:116-121. (2)Mahafzah MT, et al. J Med J. 2018;52(3):109-116. Presentation: Saturday, June 17, 2023