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THURSDAY, Jan. 23, 2020 (HealthDay News) — Teprotumumab is associated with better outcomes than placebo among patients with active thyroid eye disease, according to a study published in the Jan. 23 issue of the New England Journal of Medicine<\/i>.<\/p>\n
Raymond S. Douglas, M.D., Ph.D., from the Cedars-Sinai Medical Center in Los Angeles, and colleagues conducted a randomized phase 3 trial involving patients with active thyroid eye disease. Patients were randomly assigned to receive either intravenous infusions of the insulin-like growth factor I receptor inhibitor teprotumumab or placebo every three weeks for 21 weeks (41 and 42 patients, respectively).<\/p>\n
The researchers found that the percentage of patients with a proptosis response at week 24 was higher for teprotumumab than placebo (83 versus 10 percent), with a number needed to treat of 1.36. All secondary outcomes were significantly better with teprotumumab than placebo, including overall response, Clinical Activity Score of 0 or 1, mean change in proptosis, diplopia response, and mean change in the Graves’ ophthalmopathy-specific quality-of-life overall score. In six patients in the teprotumumab group, reductions in extraocular muscle, orbital fat volume, or both were seen. Adverse events were mostly mild or moderate in severity; in the teprotumumab group, two serious events occurred.<\/p>\n
“The effect of teprotumumab was rapid for each outcome, which was evident at the first postbaseline assessment at week six, and the outcomes continued to improve over the 24-week treatment period,” the authors write.<\/p>\n
Several authors disclosed financial ties to biopharmaceutical companies, including Horizon Therapeutics, which manufactures teprotumumab and funded the study.<\/p>\n
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