Understanding and Managing Adverse Events in Patients Treated with Tepezza

Tepezza (teprotumumab) has emerged as a groundbreaking treatment for thyroid eye disease, offering hope to patients with this rare condition. Approved by the FDA in January 2020, Tepezza has shown remarkable efficacy in reducing eye bulging and double vision. However, like any medication, it is important to be aware of the potential adverse events associated with its use and the long-term ramifications these events can have for users. 

What is Thyroid Eye Disease?

Thyroid eye disease (TED), also known as Graves’ ophthalmopathy, is an autoimmune disorder characterized by inflammation of the muscles and fatty tissues behind the eyes. This inflammation leads to proptosis, causing the eyes to bulge and creating functional and cosmetic issues for patients. Tepezza was specifically developed to address this condition and has shown significant success in clinical trials and among patients with thyroid eye disease. 

Adverse Events Associated with Tepezza Treatment

Research studies and real-world experiences have demonstrated the dramatic response of patients to Tepezza treatment. Users have reported significant improvement in proptosis and double vision, sometimes after just one or two treatments. The effectiveness of Tepezza has been unparalleled, with no other treatment showing such promising results.

However, given the rise in Tepezza lawsuits alleging hearing loss and other long-term complications linked to the TED medication, it is important to acknowledge the potential adverse events that may occur in Tepezza users. A study published last month in the journal Ophthalmology, “Teprotumumab-Related Adverse Events in Thyroid Eye Disease,” aimed to do just that, assessing “the duration, incidence, reversibility, and severity of adverse events in patients treated with teprotumumab.”

Incidence and Severity of Adverse Events

The Ophthalmology study looked at 131 patients with thyroid eye disease treated with at least four infusions of teprotumumab between February 2020 and October 2022 at six tertiary centers. The researchers reported that 81.7% of the patients experienced adverse events. These events ranged from mild to severe, with 28.2% classified as moderate and 8.4% as severe. Patients experienced a median of four adverse events, with the onset occurring at a mean interval of 7.9 weeks after the first infusion.

Types of Adverse Events

The most commonly reported adverse events associated with Tepezza treatment included mild symptoms such as muscle spasms, hyperglycemia, and inflammatory bowel disease. However, some patients experienced more severe events, such as hearing loss. These adverse events, although relatively rare, can have significant implications for patients and should be carefully monitored and managed.

In certain cases, the severity of adverse events experienced by patients in the Ophthalmology study led to the discontinuation of Tepezza treatment. Approximately 12.2% of patients discontinued treatment due to adverse events. This highlights the importance of open and transparent conversations between healthcare professionals and patients regarding the potential risks and benefits of Tepezza treatment.

Multidisciplinary Approach to Adverse Event Management

To effectively manage the adverse events associated with Tepezza treatment, a multidisciplinary approach is essential. Ophthalmologists, audiologists, and gastroenterologists should work together to provide comprehensive care and support for patients. Collaboration between these specialists ensures that adverse events are promptly identified, monitored, and treated.

Audiological Evaluation and Monitoring

Hearing loss has been reported as a potential adverse event associated with Tepezza treatment. As a proactive measure, baseline audiological evaluations should be conducted for patients before initiating treatment. Regular monitoring of hearing function is also necessary throughout the treatment period to detect any changes or deterioration promptly.

Gastrointestinal Assessment and Care

Patients treated with Tepezza should be aware of the potential exacerbation of inflammatory bowel disease (IBD) as an adverse event. Gastroenterologists play a crucial role in assessing patients for pre-existing IBD and managing any symptoms that may arise during treatment. Regular communication between ophthalmologists and gastroenterologists ensures comprehensive care for patients with thyroid eye disease.

Diabetes Management

Tepezza treatment can potentially impact blood glucose levels, leading to hyperglycemia in some patients. Ophthalmologists should collaborate with endocrinologists or primary care physicians to monitor and manage blood glucose levels during treatment. Patients with pre-existing diabetes require particular attention and may need adjustments to their diabetes management plan.

Patient Education and Counseling

An integral part of managing adverse events in patients treated with Tepezza is patient education and counseling. It is essential to ensure that patients and their families have a thorough understanding of the potential risks associated with treatment. Open discussions regarding adverse events, including hearing loss, should be held to empower patients to make informed decisions about their treatment.

What Tepezza Users Should Know

Tepezza has revolutionized the treatment of thyroid eye disease, offering hope and vision improvement for patients with TED. However, it is important to acknowledge and manage the potential adverse events that can occur during and after treatment. Proper monitoring, patient education, and collaboration among healthcare professionals can help minimize the impact of adverse events on patients’ overall well-being.