June 16, 2024

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Graves’ disease and thyroid eye disease are linked to hearing loss, according to several presentations at the 2023 Endocrine Society Annual Meeting (ENDO). Graves’ disease is an autoimmune disorder that can cause hyperthyroidism. The immune system attacks the thyroid, causing it to make excess thyroid hormones, which control the way the body uses energy. Graves’ disease affects nearly 1 in 100 Americans, according to the National Institute of Diabetes and Digestive and Kidney Diseases. About 4 out of 5 cases of hyperthyroidism in the United States are caused by Graves’ disease.

More than one-third of people with Graves’ disease are thought to have eye problems, which include bulging eyes, grittiness, puffiness, light sensitivity, pain or blurred or double vision, according to the NIH.

Decreased hearing, particularly at high frequencies, has been observed in people with Graves’ disease, but the data are limited. This batch of research will help fill in the picture.

One analysis of claims data presented at ENDO 2023 explored the link between thyroid autoimmune conditions and ear and hearing-related medical claims The analysis looked at ear and hearing-related issues in patients with Graves’ disease, including those with thyroid eye disease, and those who have taken Tepezza (teprotumumab-trbw), based on claims data. Investigators used the Komodo Health database, which includes claims data from multiple payers and clearinghouses. The database identified 469,720 Graves’ patients, 38,566 thyroid eye disease patients, and 967 Tepezza patients. Patients in the Graves’ group did not have thyroid eye disease, and patients in the thyroid eye disease group had not been treated with Tepezza. About 24% of patients with Graves’ disease, 33% of those with thyroid eye disease, and 32% of patients treated with Tepezza had ear-related claims, which included not only hearing loss and ototoxicity but also congenital abnormalities, other ear disease and injuries.

Investigators also found that of those with Graves’ disease, 7.8% of patients had any ear-related claims before diagnosis. Of those with thyroid eye disease, 9.4% had ear-related claims before diagnosis, and of those treated with Tepezza, 17% had ear-related claims before the first infusion.

“The robust patient experience, made available through these medical claims-based analyses, has helped illustrate the correlation between thyroid autoimmunity and hearing-related challenges. The analyses highlight the need for screening and evaluation of this patient community,” Terry J. Smith, M.D., study author and professor emeritus at the Department of Ophthalmology and Visual Sciences, W.K. Kellogg Eye Center, University of Michigan Medical School, said in a press release.

Two additional analyses presented at ENDO 2023 assessed data from clinical studies of patients who received Tepezza, which is FDA approved to treat thyroid eye disease. The studies were sponsored by Horizon Therapeutics, the manufacturer of Tepezza. In one analysis, investigators assessed reports of hearing-related events in eight oncology trials with 633 patients where Tepezza was administered either as a monotherapy or in combination with other cancer therapies. Before FDA approval for treating patients with thyroid eye disease, Tepezza was evaluated as a potential cancer therapeutic. In clinical trials, hearing-related adverse events with insulin-like growth factor-I receptor inhibitors have been reported.

Of the 633 patients, 51 patients (8.1%) reported ear-related adverse events and 13 patients (2.1%) reported ear adverse events that were considered related to Tepezza. About 80% of reported adverse events were considered mild. The few moderate and severe events related to Tepezza were mostly at higher drug exposures than those used in the Tepezza thyroid eye clinical trials.

Investigators assessed quality-of-life questionnaires in the phase 2 and phase 3 trials, as well as an extension study, for the thyroid eye indication. In the three trials, 12 of the 121 Tepezza-treated patients had ear-related adverse events, including tinnitus, hearing loss/impairment, hyper/hypoacusis, autophony, eustachian tube dysfunction, according to a presentation at the 2023 American Association of Clinical Endocrinology Annual Meeting.

None of the patients who reported a treatment-emergent hearing-related adverse event in these clinical trials withdrew from treatment. Quality-of-life scores improved in these patients independent of experiencing a hearing related adverse event. Investigators concluded that Tepezza-treated patients with hearing-related adverse events during treatment benefited from treatment, experiencing clinically significant improvement in quality of life.

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