Teprotumumab, a minimally invasive insulin growth factor I-blocking antibody, improves symptoms, appearance and quality of life in patients with thyroid disease, according to a study.
The results of the study were published in the New England Journal of Medicine. The randomized, double-blind, placebo-controlled trial was conducted by the Department of Surgery at Cedars-Sinai and at other medical centers across the country.
Thyroid eye disease is a rare sight-threatening autoimmune disease that causes inflammation and enlargement of the muscles and fatty tissues behind the eye, resulting in bulging eyes. In addition to a bulging appearance, patients may experience double vision and sensitivity to light. The disease can lead to blindness.
“The study demonstrates that teprotumumab treatment is effective in reversing the disease and provides new hope for patients,” said the study’s principal investigator, MD, PhD. Sinai. Patients received the drug intravenously once a week for three weeks for 21 weeks. The results showed:
Patients receiving teprotumumab experienced an effective response in two doses or six weeks of administration. After 24 weeks, the study showed that 83% of people taking this drug had a measurable reduction in eye bulging, compared to 10% of people taking a placebo.
The overall response rate was 78% among those taking the drug, compared to 7% of people taking a placebo. The new discovery helped prompt the US Food and Drug Administration’s approval of the drug, sold under the brand name Tepezza, making it the first drug approved for the condition.
“Other than highly invasive surgical procedures, patients with thyroid disease have had no real treatment alternatives,” Douglas said. “This is a breakthrough in medicine for a very large percentage of the patient population who will quickly receive alternative medical infusion therapy with great results.” Teprotumumab is a fully human monoclonal antibody that blocks the inflammatory autoimmune pathophysiology underlying thyroid disease.
“This treatment has the potential to change the course of the disease, potentially sparing patients from the need for multiple invasive surgeries by providing an alternative, non-surgical treatment option,” said Wiley Chambers, M.D., deputy director of the Division of Transplantation and Ophthalmology Products at the FDA’s Center for Drug Evaluation and Research.
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