Amgen has reported positive topline results from a phase 3 trial evaluating a subcutaneous formulation of Tepezza (teprotumumab‑trbw) delivered via an on‑body injector in adults with moderate‑to‑severe active Thyroid Eye Disease (TED). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful proptosis response rate of 76.7% with subcutaneous Tepezza compared with 19.6% for placebo at week 24 during the placebo‑controlled period (p<0.0001). Mean proptosis reduction, a key secondary endpoint, reached 3.17 mm at week 24 versus 0.80 mm for placebo (p<0.0001).
According to Amgen, the subcutaneous regimen provided efficacy comparable to the approved intravenous formulation of Tepezza, which is the first and only medicine indicated for TED and has treated more than 25,000 patients worldwide. The phase 3 trial also achieved multiple additional secondary endpoints, including overall responder rate, proportion of patients achieving a Clinical Activity Score of 0 or 1, several diplopia (double vision) measures, and improvement in the Graves’ Ophthalmopathy Quality of Life appearance subscale.
Safety findings for subcutaneous Tepezza were generally consistent with the known profile of the intravenous product. Mild‑to‑moderate injection‑site reactions occurred in some patients but did not lead to treatment interruption or discontinuation. The most common adverse events (≥10%) included muscle spasms, tinnitus, weight decrease, ear discomfort, nausea, and diarrhea. Amgen noted that TED is a serious, progressive, and potentially vision‑threatening rare autoimmune disease that can cause eye bulging, double vision, pain, redness, and swelling.
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