Study of Teprotumumab Treatment for Adults with Active Thyroid Eye Disease and Related Thyroid Problems

What this Trial Is About

Researchers are evaluating the clinical outcomes of patients with active thyroid eye disease TED, a rare autoimmune condition that affects the eye muscles and tissues, causing symptoms like proptosis, pain, double vision, and swelling. The study focuses on adults with moderate to severe TED who show signs such as pain, diplopia, eyelid or orbital swelling, and redness. The condition can significantly impact vision and quality of life, and this research aims to assess treatment outcomes under medical supervision. The treatment under observation is teprotumumab Tepezza, a monoclonal antibody that targets the underlying inflammatory process in TED. Patients recommended for this infusion therapy will be evaluated by specialists including an oculoplastic surgeon and an endocrinologist. The study involves a retrospective review of medical records for adults without urgent optic nerve compression requiring surgery or radiation. The treatment period and follow-up span 6 to 12 months post-treatment to observe clinical activity and antibody levels. Participants will undergo clinical activity scoring and thyroid stimulating immunoglobulin testing between 6 and 12 months after treatment. Researchers will also analyze HLA subtypes to explore their relationship with treatment response. The study involves detailed monitoring of symptoms such as proptosis and diplopia, with safety considerations excluding patients with uncontrolled diabetes, inflammatory bowel disease, or pregnancy. Participation includes regular evaluations and laboratory testing to track disease activity and immune markers over time.

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction