Tuesday, March 23, 2021 (HealthDay News)
The first drug approved in the United States to treat thyroid eye disease can have unwanted side effects for many. A small new study found that up to two-thirds of patients taking the drug experienced hearing impairment.
Teprotumumab (Tepezza) was approved by the US Food and Drug Administration in January 2020. Hearing impairment was reported in 10% of patients in two clinical trials conducted before the FDA approved the drug. But the new study found that the percentage could be as high as 65%, the researchers said.
The findings were recently presented at the Virtual Annual Meeting of the Endocrine Society.
Thyroid ophthalmopathy is an autoimmune disease in which the muscles of the eye and the adipose tissue behind the eye become inflamed and is primarily associated with thyroid overactivity due to Graves’ disease.
Symptoms of thyroid eye disease include dry, watery, red or swollen eyes, “staring”, diplopia, difficulty closing eyes, and vision problems.
Teprotumumab has been shown to be given to patients in a total of eight infusions, once every three weeks, and has been shown to be of great benefit to patients, the study authors said in a social news release.
This latest study included 26 patients treated with at least four infusions of teprotumumab. Seventeen (65%) of patients reported new hearing impairments.
The most common were deafness (23%), tinnitus (27%), tinnitus (12%), and spontaneity, abnormally high hearing in one’s own voice (29%). Symptoms developed after an average of 3.6 injections of teprotumumab.
Of the 17 patients with new hearing impairment, 4 suffered from new or exacerbated sensorineural hearing loss due to damage to the hair cells of the inner ear. Two of those four patients had improvement in symptoms at 1 and 6 months, the findings showed.
Three patients had patulous eustachian tube. This is a disorder in which the channels running between the middle ear and the back of the nose and throat remain open. Normally, these Eustachian tubes open and close only occasionally to regulate the air pressure around the eardrum. After three months, the symptoms of the condition improved, but did not disappear completely, the researchers said.
Senior research author Dr. Andrea Lola Kosler said the study’s follow-up period of three months after discontinuing the drug was too short to assess whether such hearing problems could be remedied. Stated. She is an assistant professor of ophthalmology at Stanford University School of Medicine in California. Future studies will assess risk factors for deafness and reversibility of symptoms, she said.
Studies presented at medical conferences should be considered preliminary until published in a peer-reviewed journal.
For more information
The National Organization for Rare Disorders details thyroid ophthalmopathy.
Source: Endocrine Society, News Release, March 20, 2021
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