Evaluating the Safety and Effectiveness of Tetuzumab and Hormone Therapy for Adults with Moderate to Severe Active Thyroid-Associated Ophthalmopathy After Glucocorticoid Treatment

What this Trial Is About

Thyroid-associated ophthalmopathy TAO is an autoimmune disease linked to thyroid problems, commonly seen in adults and often resulting from Graves disease. It can cause complex symptoms, ranging from mild issues to severe vision impairment or even blindness. This research evaluates the effects of Tetuzumab IBI311, an antibody that blocks specific growth factor receptors, in patients with moderate to severe active TAO who have previously undergone glucocorticoid treatment but did not respond well or had unsatisfactory outcomes. Participants receive different treatments based on their prior glucocorticoid use. Those who had more than 6 grams of glucocorticoids may receive 8 infusions of teprotumumab. Those with less than 6 grams of glucocorticoids may receive either 8 infusions of IBI311 or intravenous methylprednisolone injections, starting with 500 mg daily for 3 days, then every 2 weeks for a total of 8 treatments, not exceeding 12 grams in total. These therapies are given over a treatment period of up to 24 weeks. During the study, researchers assess treatment response after 4 infusions and at the end of treatment, measuring overall response, clinical activity scores, eye movement, eye protrusion, antibody response, quality of life, and changes in visual field. Safety is monitored by tracking adverse events through about one year after treatment. Participants undergo regular evaluations including clinical assessments and laboratory tests throughout the study period, which spans up to 24 weeks of treatment and follow-up.

Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment.