SPRINGFIELD, Mo. - Thyroid eye disease (TED) is an autoimmune condition primarily driven by autoantibodies that contribute to inflammation and tissue changes around the eyes. Patients with TED experience signs and symptoms that impact their quality of life such as proptosis, eye pain, redness, dryness and double vision.
Treatment options for patients with TED include medical and surgical management. Physicians have widely used steroid therapy to manage the disease, but they do not work for all patients and can come with unwanted side effects. Teprotumumab, another medical option, is administered as an intravenous infusion every three weeks for up to eight treatments.
Researchers are exploring newer immunotherapy approaches to target the underlying cause of TED rather than broadly suppressing the immune system, like what which occurs with steroid therapy. The UplighTED research study is evaluating Efgartigimod (ef-GAR-ti-ji-mod) PH20 SC administered by weekly subcutaneous injection, for treatment of active, moderate-to-severe TED associated with autoimmune thyroid conditions. Efgartigimod alfa and hyaluronidase-qvfc is FDA approved for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
“Thyroid eye disease is primarily due to autoantibodies," said Dr. Johnson Thomas, endocrinologist at Mercy Springfield and principal investigator for Mercy Research for the enrolling UplighTED study investigating Efgartigimod. "Efgartigimod reduces the pathogenic antibodies there by attacking the root cause of the disease.”
About the Study
This Phase 3, randomized, double-masked, placebo-controlled clinical trial at Mercy Endocrinology-Smith Glynn Callaway and Mercy Clinic Eye Specialists - Ophthalmology - E. Seminole is currently investigating the therapy to address the root cause of the disease. The study is evaluating the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of Efgartigimod PH20 SC. Efgartigimod may offer an alternative to steroids and another non-surgical option.
“Steroids cause weight gain, increase the chance of diabetes, osteoporosis, and mood changes," Dr. Thomas said. "Efgartigimod was well-tolerated in myasthenia gravis, except for the possibility of mild infections. This may also induce longer-lasting reductions in autoantibody levels, potentially modifying disease progression.”
If investigators observe similar benefits in patients with TED, this study could help in determining whether Efgartigimod might provide a more sustainable long-term treatment option for TED patients.
