According to a story from morningstar.com, the pharmaceutical company Horizon Therapeutics plc recently announced the completion of enrollment for its phase 3 clinical trial in Japan. This trial is testing TEPEZZA as a treatment for active thyroid eye disease. This medication has been approved in the US for this disease, but currently there is no approved therapy for thyroid eye disease in Japan. This trial includes adult patients with moderate to severe disease.
About Thyroid Eye Disease (TED)
Thyroid eye disease, which is also known as Graves’ ophthalmopathy, is an inflammatory disorder affecting the eyes and the surrounding tissues. The disease is autoimmune in nature and most common appears alongside Graves’ disease, an autoimmune illness that affects the thyroid. Hyperthyroidism is a significant risk factor. It can also appear in patients with Hashimoto’s thyroiditis. Women are more likely to affected than men, but men tend to be affected at older ages and have worse prognosis. Regardless it can also appear on its own without comorbidity. Symptoms of the disease include lid lag, upper eyelid retraction, eye bulging, swelling, eye inflammation, and redness around the eyes. Severe cases, while rare, are a medical emergency that can threaten vision and inflict severe pain. In mild cases thyroid eye disease may eventually resolve on its own. Treatment may include corticosteroids, surgery, topical lubrication, and selenium supplementation. To learn more about thyroid eye disease, click here.
Trial Info
Participants in the trial will receive either a placebo or TEPEZZA once every three weeks. A total of eight doses will be administered, with the first at 10 mg/kg and the remaining seven being 20 mg/kg. The primary endpoint for this trial will be proptosis (eye bulging) rate of response at 24 weeks. This will be assessed by the percentage of patients who see a reduction in proptosis of at least 2 mm.
Hopefully this trial will be an important step in getting a treatment for this debilitating illness approved in Japan.
