Assessment of Hearing Dysfunction in Patients With Graves’ Disease and Thyroid Eye Disease Without or With Teprotumumab
Authors' 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.
Study context
- Population
- Patients with Graves' disease (GD), thyroid eye disease (TED), and teprotumumab-treated patients in a medical claims database; teprotumumab oncology and TED clinical trials
- Participants
- 469,720 / 38,566 / 967
- Exposure
- GD without TED vs TED without teprotumumab vs TED with teprotumumab
- GDn = 469,720
- TEDn = 38,566
- Teprotumumabn = 967
- Outcome
- Ear-related diagnostic codes/hearing AEs in GD, TED and teprotumumab-treated patients (ear/labyrinth-related ICD codes in claims; hearing AE incidence/severity in clinical trials)
Methodological detailsdeidentified claims (KOMODO), pooled teprotumumab clinical trials
- Deidentified claims (KOMODO)
- Pooled teprotumumab clinical trials
Main finding
As reported in the abstract
Ear-related codes (including those not specific for hearing)
Observational data: associations, not effects.
Further findings
Sensorineural hearing loss bilateral (most frequent code)
Ear-related codes before vs after teprotumumab
- Ear-related codes before teprotumumab use
- 17.1% (165)
- New ear-related codes post treatment
- 10.1% (98)
GO-QOL
- GO-QOL improved in teprotumumab-treated patients without/with hearing adverse events (AEs)
Safety
Ear/labyrinth disorders and hearing AEs in 8 teprotumumab oncology trials
- Ear/labyrinth disorders
- 8.1% (51/633)
- Ear/labyrinth disorders considered study-drug-related
- 2.1% (13)
- Hearing impairment/tinnitus-related AEs
- 3.8% (24)
- Hearing impairment/tinnitus-related AEs considered study-drug-related
- 1.3% (8)
- Similar rates occurred in TED trials
- Incidence/severity consistent across chronic and acute TED
Original publication
Assessment of Hearing Dysfunction in Patients With Graves’ Disease and Thyroid Eye Disease Without or With Teprotumumab. J Clin Endocrinol Metab. Published 14 August 2024. doi:10.
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