Teprotumumab does not raise rates of hearing-related adverse events in thyroid eye disease
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Key takeaways:
- Adults with thyroid eye disease receiving teprotumumab have similar rates of hearing dysfunction as untreated adults.
- A higher risk for hearing-related events with teprotumumab was not seen in multiple trials.
Adults receiving teprotumumab for the treatment of thyroid eye disease experience a similar number of hearing-related adverse events as those not treated with teprotumumab, according to new data.
As Healio previously reported, a small prospective cohort study found most adults who experience hearing loss after initiating teprotumumab-trbw (Tepezza, Amgen) had hearing dysfunction before starting the drug. New data published in The Journal of Clinical Endocrinology & Metabolism found the occurrence of hearing-related conditions was similar among those receiving teprotumumab as those not taking the therapy in a real-world claims database as well as in multiple clinical trials.
“Studies examining patients with Graves’ disease but not treated with teprotumumab have reveal decreased hearing ability, especially at high frequencies, with mild-moderate sensorineural hearing loss noted in as many as 23.5% of patients,” Terry J. Smith, MD, professor of internal medicine and the Frederick G.L. Huetwell Professor Emeritus in Ophthalmology and Visual Sciences at the University of Michigan, and colleagues wrote. “Observations ascertained from claims-based data reported here demonstrate comparable or lower rates of hearing-related medical claims among patients receiving teprotumumab when compared with Graves’ disease patients without or with thyroid eye disease not receiving teprotumumab.”
Real-world claims data
Researchers assessed hearing-related adverse events in four groups of people receiving teprotumumab. In the first analysis, data were collected from the Komodo Health claims database from Sept. 30, 2015, to Aug. 5, 2022. The analysis included adults with Graves’ disease and no thyroid eye disease diagnosis, those with thyroid eye disease not receiving teprotumumab and adults with thyroid eye disease treated with teprotumumab. ICD-10 ear- and hearing-related codes were collected from 1 year before the first Graves’ disease or eye manifestation code to 6 months after the first eye code for those not treated with teprotumumab, and from 1 year before the first teprotumumab infusion to 6 months after the initial infusion for those receiving the therapy.
The database included 469,720 adults with Graves’ disease, 38,566 people with thyroid eye disease and 967 adults using teprotumumab. Ear-related claims were reported among 24% of the Graves’ disease group, 33% of those with thyroid eye disease and 32% of adults treated with teprotumumab. Sensorineural hearing loss was the most frequently reported claim, occurring in 7% of the Graves’ disease group, 11.1% of the thyroid eye disease group and 10.8% of the teprotumumab group.
Of adults receiving teprotumumab, 17.1% had an ear-related claim before starting therapy, 10.1% had a claim after their first infusion and 4.7% reported a hearing-related claim before and after teprotumumab therapy began.
Trial data
In the second analysis, researchers collected ear and labyrinth disorder events from 633 adults receiving teprotumumab on its own or combined with other therapies in oncology clinical trials. Ear or labyrinth disorder events occurred in 8.1% of participants, with 2.1% of adults experiencing an event that was related to teprotumumab. Of 50 adults who had an ear or labyrinth event, 29 reported it within 60 days of starting teprotumumab, and 82% of events were deemed mild in severity.
The third analysis examined hearing-related adverse events for participants receiving teprotumumab in the phase 2 and phase 3 OPTIC trials and the OPTIC extension trial. In all three trials, adults diagnosed with thyroid eye disease within 9 months of enrollment and a clinical activity score of 4 or higher, as well as OPTIC placebo nonresponders who received teprotumumab during the extension trial, were included. Adverse events included tinnitus, hearing loss or impairment, hyperacusis or hypoacusis, autophony and eustachian tube dysfunction. Graves’ ophthalmopathy quality of life was assessed for adults with hearing-related adverse events and those without a hearing-related event.
Of 121 adults assessed across the trials, 12 reported a treatment-emergent hearing-related adverse event. All but two of the adverse events were resolved at the time of follow-up, and 10 of the 13 events were mild in severity. Graves’ ophthalmopathy quality of life scores improved after teprotumumab therapy compared with baseline, regardless of whether participants had a hearing-related adverse event.
The final analysis assessed data from a phase 4 trial of adults with longstanding chronic thyroid eye disease for 2 to 10 years and a clinical activity score of less than 1. Hearing-related adverse events were reported by 22% of adults receiving teprotumumab and 10% receiving placebo.
Baseline hearing exam crucial
The researchers said providers should conduct hearing examinations before starting teprotumumab therapy and discuss possible risk factors with patients before initiating treatment.
“Given the evolving nature of reports of hearing adverse events assigned to teprotumumab, especially in those with existing hearing impairment, it is prudent for clinicians to assess patients’ hearing before, during and after treatment with teprotumumab and discuss the benefit-risk of treatment with patients as currently recommended in the prescribing information for the product,” the researchers wrote.
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