Horizon Therapeutics plc released results from a study assessing the real-world use of Tepezza (teprotumumab-trbw) for treating patients with thyroid eye disease (TED) and, as a result, dysthyroid optic neuropathy (DON).
Tell me more about DON.
Dysthyroid optic neuropathy (DON) is a complication of TED that is characterized by thyroid-related vision impairment, potentially leading to permanent vision loss due to optic nerve compression.
Refresh on Tepezza?
With FDA approval in 2020, Tepezza is the first and currently only treatment indicated for TED; the recommended dosage consists of 10 mg/kg intravenously injected into the arm followed by a second injection of 20 mg/kg every three for weeks for seven additional infusions.
Now talk about this new data.
The analysis focused on 24 patients—identified from literature and clinical experience from the author—with TED who were also diagnosed with DON and treated with Tepezza between January 2020 and September 2022. Out of the 24 patients, 22 received oral or intravenous steroids, surgery, and/or radiation before receiving Tepezza injections.
Findings?
Following Tepezza, that the following was observed:
- Visual acuity in eyes with DON showed a meaningful improvement (with mean lines of improvement of 3.7 [23 patients], range 1-15, and a meaning improvement in mean deviation on visual field [VF] testing of -5.87 [7 patients]).
- Proptosis showed a mean reduction of 4.4 mm (19 patients).
- Diplopia showed a mean improvement of 0.75 grade (8 patients).
- Clinical Activity Score (CAS) showed a mean reduction of 5.1 (7 patients).
Any adverse events?
Those reported were in line with previous adverse events (AEs) observed in the clinical trials for Tepezza, including fatigue, dysgeusia, hearing impairment, hyperglycemia, nausea, and muscle spasms.
Significance?
According to study author Madhura A. Tamhankar, MD, eyecare practitioners looking for an option for TED patients suffering from DON should be encouraged by the real-world data and view it as evidence that Tepezza can potentially help alleviate patients' symptoms and preserve visual acuity.
This article has been corrected as of 5/1. Tepezza is intravenously administered via the arm, not the eye.