Thyroid Eye Disease (TED), also known as Graves’ ophthalmopathy, is an autoimmune condition often associated with Graves’ disease where the immune system attacks the muscles and fatty tissues behind the eyes. In January 2020, the U.S. Food and Drug Administration (FDA) approved teprotumumab-trbw (Tepezza) as the first medication specifically indicated for the treatment of TED in adults.
What is Thyroid Eye Disease?
Thyroid eye disease is an inflammatory condition that causes the tissues behind the eye to swell. According to the American Academy of Ophthalmology, this swelling pushes the eyes forward, resulting in proptosis, or bulging eyes. Patients often experience double vision, light sensitivity, severe dryness, and in rare, severe cases, vision loss due to pressure on the optic nerve.
The condition is linked to the thyroid gland, which regulates the body’s metabolism. While most people with TED have an overactive thyroid, some individuals with normal thyroid function or even an underactive thyroid can still develop the disease.
How Does Teprotumumab Work?
Teprotumumab is a human monoclonal antibody that functions as an insulin-like growth factor-1 receptor (IGF-1R) inhibitor. By blocking the IGF-1R protein, the drug reduces the inflammation and swelling of the orbital tissues.
The FDA approval was based on data from two clinical trials, OPTIC and REACH, which demonstrated significant improvements in proptosis compared to a placebo. Participants in these studies received infusions every three weeks for a total of eight doses.
Common Side Effects and Considerations
While the treatment offers a new option for patients, it carries potential side effects. Clinical trial data reported by the National Institutes of Health indicate that the most common adverse reactions include:
- Muscle spasms
- Nausea
- Alopecia (hair loss)
- Diarrhea
- Fatigue
- Hearing impairment or loss
- Hyperglycemia (high blood sugar)
Because of the risk of hearing impairment, clinical guidelines suggest that patients undergo audiological assessments before and during treatment.
Current Management Strategies
Managing TED typically involves a multidisciplinary approach. Endocrinologists manage the underlying thyroid dysfunction, while ophthalmologists—specifically oculoplastic surgeons—monitor eye health.
Historically, treatment focused on managing symptoms with lubricating eye drops, prisms for double vision, or corticosteroids to reduce inflammation. In severe cases, surgical decompression was the standard of care to relieve pressure on the optic nerve. The introduction of targeted biologic therapies like teprotumumab has shifted the treatment landscape, allowing for medical intervention that targets the underlying autoimmune mechanism rather than just managing the physical symptoms.
Frequently Asked Questions
Is thyroid eye disease the same as Graves’ disease?
No, but they are related. Graves’ disease is an autoimmune thyroid disorder. Thyroid eye disease is an inflammatory condition that occurs in some people with Graves’ disease.
Who is a candidate for teprotumumab?
The FDA approved teprotumumab for the treatment of TED in adults. Eligibility is typically determined by an ophthalmologist or endocrinologist based on the severity and activity level of the disease.
Can the disease return after treatment?
While treatments can significantly reduce symptoms, patients remain at risk for recurrence. Ongoing monitoring by a specialist is essential to track thyroid hormone levels and orbital inflammation.