Managing the Adverse Events in Patients Treated with Tepezza | AAO 2023

In a real-world study, patients treated with Tepezza (teprotumumab) for thyroid eye disease had a dramatic response, with significant decreases in eye bulging and seeing double. And although treatment-related adverse events were mild for most patients, some experienced hearing loss, inflammatory bowel disease, hyperglycemia, and muscle spasms. The results of this study were presented at the annual meeting of the American Academy of Ophthalmology and were also published in Ophthalmology in September 2023.

The FDA approved Tepezza (teprotumumab-trbw) in January 2020 to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Graves’ disease (hyperthyroidism), an autoimmune disorder, can lead to thyroid eye disease. Tepezza was developed by Horizon Therapeutics, which was acquired by Amgen in October 2023.

Sara T. Wester, M.D.

“There is nothing else I’ve seen that has this dramatic response,” researcher Sara T. Wester, M.D., professor of clinical ophthalmology, Bascom Palmer Eye Institute at the University of Miami, said during her presentation.

She highlighted patients who have had significant improvement in proptosis and diplopia (double vision), sometimes after just one or two treatments.

In her practice, Wester has seen nonresponders, who usually have long-term thyroid disease.

Wester and her colleagues participated in a multi-center study to assess the adverse events in patients who were treated with Tepezza from February 2020 and October 2022. Researchers found that 81.7% of the 131 patients evaluated experienced adverse events and these patients had a median of four events. Mean interval of adverse event onset was 7.9 weeks after the first infusion. Forty-six percent of patients had at least one persistent adverse event at last follow-up.

Most adverse events were mild, but 28.2% of events were moderate and 8.4% of events were severe. In fact, 12.2% of patients discontinued treatment because of adverse events, including hearing loss, inflammatory bowel disease, hyperglycemia, and muscle spasms.

“We need to be having conversations about adverse events,” she said. “We need to make sure patients and their families understand the risks about possible hearing loss, and exacerbations of IBD.”

Treatment with Tepezza should be multidisciplinary, Wester said. She works with an audiologist and a GI to help manage adverse events. She also does baseline testing of patients, especially those with diabetes. She also counsels patients to avoid pregnancy for six months after last infusion.

“We’re not used to doing this in ophthalmology when we do infusion therapies, but we have to be thinking about the systemic implications for these patients.”