Evidence map›Paper›PMID 39138817›Full record

ArticleThe Journal of clinical endocrinology and metabolism2025

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

Terry J Smith, Robert J Holt, Qianhong Fu, Anahita Qashqai, Naina Barretto, Elizabeth Conrad, Jason A Brant

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Article in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

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0cells of the map it votes in
5citing papers in PubMed
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1 · What the graph read from it

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3 · Its place in the literature

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5 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Terry J SmithDepartment of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, and Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI 48105, USA.ORCID 0000-0002-6279-9685
Robert J HoltMedical Affairs, Amgen Inc, Thousand Oaks, CA 91320, USA.
Qianhong FuMedical Affairs, Amgen Inc, Thousand Oaks, CA 91320, USA.
Anahita QashqaiMedical Affairs, Amgen Inc, Thousand Oaks, CA 91320, USA.
Naina BarrettoMedical Affairs, Amgen Inc, Thousand Oaks, CA 91320, USA.
Elizabeth ConradMedical Affairs, Amgen Inc, Thousand Oaks, CA 91320, USA.
Jason A BrantDepartment of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA 19104, USA.

Funding

Endocrine Society Annual Meeting
6 · The paper itself

Abstract

contextThyroid 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.

objectiveThis work aimed to quantify ear-related diagnostic codes/hearing AEs in GD, TED, and patients receiving teprotumumab by examining medical claims and clinical trials.

methodsDeidentified 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.

resultsGD (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.

conclusionThese 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.

Indexed as

Antibodies, Monoclonal, HumanizedGraves DiseaseGraves OphthalmopathyHearing LossAdultAgedFemaleHumansIncidenceMaleMiddle AgedQuality of LifeYoung AdultAntibodies, Monoclonal, HumanizedteprotumumabGraves’ diseasehearing lossteprotumumabthyroid eye disease

Identifiers

PMID39138817
PMCPMC11834702

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.