Thyroid eye disease (TED) can be a debilitating condition, causing bulging eyes, vision problems, and pain. Tepezza offered a ray of hope as the first FDA-approved medication specifically targeting the disease. However, recent reports and ongoing lawsuits have raised concerns about a potential side effect – hearing loss.
This article discusses this complex issue. We’ll explore the potential benefits of Tepezza for TED while also examining the reported risks of hearing loss associated with the drug.
Tepezza’s Benefits for TED
The American Academy of Ophthalmology highlights the prevalence of TED. Their study identified 41,211 cases of the disease, indicating an overall prevalence rate of 0.09%. The highest prevalence rate occurred in individuals aged 50–54 years, with women experiencing a three-fold higher rate than men.
Additionally, current and former smokers and patients with type 1 diabetes were more susceptible to the disease.
TorHoerman Law notes that before Tepezza’s arrival, treatment for TED primarily focused on managing symptoms. However, this drug offers a potential breakthrough by targeting the underlying cause of the disease.
The drug works by inhibiting the insulin-like growth factor-1 (IGF-1R) receptor, which plays a crucial role in the pathogenesis of TED. This inhibition helps in reducing the inflammatory and fibrotic processes that cause the characteristic symptoms of TED.
Clinical studies support these potential benefits. According to a high-level analysis reported by Ophthalmology Times, the drug has shown impressive long-term efficacy. In a follow-up study, 82% of Tepezza-treated patients did not require any additional TED treatment for nearly two years (99 weeks).
This is the longest follow-up period to date, underscoring the treatment’s lasting benefits. Of the 106 patients in the study, only 18% required further intervention, including systemic steroids, teprotumumab, or remedial periocular surgery.
Potential Hearing Loss with Tepezza
Several individuals who received the drug’s infusions have reported experiencing hearing loss and tinnitus (ringing in the ears) after treatment. One such case, highlighted by the Lawsuit Information Center, involves a Florida man who underwent treatment in 2022 for TED.
Neither he nor his doctors were reportedly informed about the potential for hearing loss associated with the medication. This lack of awareness is a central theme in the ongoing Tepezza hearing loss lawsuit against its manufacturer. Plaintiffs argue that the manufacturer failed to adequately warn patients and doctors about this potential side effect.
This issue has also sparked questions about Tepezza’s marketing. According to AboutLawsuits.com, concerns exist that the drug’s rapid sales growth might have come at the expense of adequate disclosure about potential hearing loss.
To manage the influx of lawsuits, a centralized legal process known as Multidistrict Litigation (MDL) has been established. This streamlines pre-trial proceedings for similar claims, potentially leading to faster settlements or setting precedents for future cases.
As part of the MDL, “bellwether” cases have been chosen. These 12 representative cases will undergo in-depth discovery and potentially go to trial first. The outcomes of these trials can help gauge how juries view the evidence and potentially influence future settlements or verdicts in other Tepezza lawsuits.
Weighing the Options
The medication introduces a complex decision-making process for TED patients. While its potential benefits are significant, the concerns regarding hearing loss necessitate a careful and personalized approach. Here’s how patients and doctors can navigate this process:
Individualized Assessment
There’s no “one-size-fits-all” solution for TED treatment. The severity of the symptoms and individual risk tolerance will all play a crucial role in deciding if Tepezza is the right option.
A doctor will thoroughly assess the patient’s condition, considering factors like proptosis severity, inflammation levels, and potential vision impairment. Additionally, the doctor will review the patient’s medical history, including any pre-existing hearing conditions that might make Tepezza less suitable.
Baseline Hearing Evaluation
Before considering Tepezza, a pre-treatment audiology evaluation is essential. This establishes a baseline for a patient’s hearing, allowing for early detection of any potential changes during or after the treatment. The audiologist can recommend appropriate monitoring strategies throughout the treatment course.
Monitoring for Hearing Issues
During Tepezza infusions, close monitoring for potential hearing changes is crucial. This might include regular audiology assessments and reporting any subjective changes like tinnitus or difficulty hearing. Early detection of hearing loss can allow for prompt intervention, potentially minimizing long-term damage.
Staying Informed
Patients should actively participate in the decision-making process. Resources like the American Thyroid Association and the American Academy of Ophthalmology offer valuable information on TED treatment options. They can also provide information on hearing loss prevention strategies.
Exploring Alternatives
You need to understand that Tepezza isn’t the only option for TED treatment. Traditional therapies like corticosteroids and immunosuppressants are still used, with varying degrees of success. Additionally, research into new TED treatments is ongoing.
For example, according to Clinical Trials Arena, biotechnology company Viridian Therapeutics is set to initiate two Phase III clinical trials for VRDN-003, an anti-IGF-1R antibody. These trials aim to treat moderate-to-severe TED. The trials will evaluate the efficacy and safety of subcutaneous doses of VRDN-003 in both active and chronic TED patients.
Frequently Asked Questions
How does Tepezza affect hearing?
The drug can cause hearing issues such as tinnitus (ringing in the ears) and hearing loss. These side effects may be temporary or permanent and are still under investigation. Patients are advised to undergo baseline audiology tests and regular hearing monitoring during treatment.
Is Tepezza a one-time treatment?
Tepezza is not a one-time treatment. Each infusion is given once every three weeks, with the full course of treatment lasting about five months. Regular infusions are necessary to achieve the desired therapeutic effects for TED.
Who is a good candidate for Tepezza?
A good candidate for the treatment has active TED with a clinical activity score (CAS) greater than 4 and is experiencing the disease’s symptoms. Additionally, a suitable candidate must not have inflammatory bowel disease, such as Crohn’s or ulcerative colitis.
This article has explored the potential benefits of Tepezza for TED while acknowledging the reported risks of hearing loss and ongoing legal considerations. We’ve also emphasized the importance of individual patient assessment, pre-treatment audiology evaluations, and ongoing monitoring strategies. Additionally, we’ve highlighted the availability of resources and alternative treatment options for TED.
Ultimately, the decision to pursue the treatment should be made by a patient in close collaboration with their doctor. Open communication and a thorough understanding of both the potential benefits and risks are crucial for navigating TED treatment effectively.
As research continues to evolve, we can hope for even more effective and well-tolerated treatment options for TED in the future.