Findings indicate in study released today that long term hearing losses in patients with normal audiometry is rare
BEVERLY HILLS, Calif., Jan. 16, 2024 /PRNewswire-PRWeb/ -- Raymond Douglas MD, PhD led a new study finding long term hearing loss is rare in those with normal audiometry at baseline following treatment with Tepezza [teprotumumab]. The results also showed with predictability that patients with preexisting hearing issues were those who would potentially develop loss. The study was just published for the current issue of the prestigious journal Thyroid, the definitive peer-reviewed medical journal in thyroid disease, care, and research, providing multidisciplinary original and patient-focused reports.
Teprotumumab, a novel monoclonal inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) was approved in the US for the treatment of thyroid eye disease (TED) after its phase 2 and 3 clinical trials, for which Dr. Douglas served as a lead clinical investigator. In light of reports of patient experience and increasing concern regarding the potential for otologic symptoms or hearing dysfunction associated with Tepezza treatment infusions, this specific side effect was investigated in this study. The study of 52 patients (43 females and 9 males), who met the inclusion criteria, was similar in sample size and length of treatment to the initial clinical trials and investigated tone audiometry and subjective otologic symptoms before and after treatment protocol with follow up after a 6-month period.
The study found that patients with normal range baseline audiometry on the whole maintained their hearing, while in some cases there was an effect or loss only in patients who presented with abnormal audiometry at baseline. Audiometry testing protocols by trained technicians were completed at baseline and prior to every infusion followed by 3-months and 6-months after completion. Mean thresholds at each frequency per visit, per ear, were evaluated by an independent audiologist and concluded that hearing losses in normal patients are considered highly unlikely and very rare.
"Our study conclusively confirmed that hearing loss with Tepezza treatment is in fact very rare", said Dr. Raymond Douglas, lead investigator and author. "However there are always possible adverse effects of drug therapies making the comprehensive understanding of the potential of adverse events before administering these drugs necessary. Expert patient care and ongoing monitoring with Tepezza or any drug therapy is crucial to long term patient successes."
Dr. Douglas is also the founder of Thrive Health IV, treatment centers of excellence, which provide comprehensive expert care of TED patients and manages Tepezza infusion protocols, including proactive and ongoing audiology testing to stay ahead of any potential issues. The published study comes on the heels of the FDA label warning update for Tepezza to include the potential of hearing loss, which, while important to monitor, will not affect the majority of treated patients. Patient improvements and success rates with Tepezza completing the full protocol average are similar to surgical outcomes, thus a viable option for patients. Findings in the study can serve to alleviate any concerns for the TED biologic, which improves quality of life by reversing the symptoms of the condition often obviating the need for surgical intervention.
For more information visit https://thrivehealthiv.com/
Media Contact
Jill Eisenstadt Chayet, bluPRint, 1 3106502900, [email protected]
Santosh Khandhar, Thrive Health IV, 1 909.256.9199, [email protected], https://thrivehealthiv.com/
SOURCE Raymond Douglas MD
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