IBI311 and Glucocorticoids: A New Approach for Severe Thyroid Eye Disease

Thyroid Associated Ophthalmopathies (TAO), also known as Thyroid Eye Disease (TED), is an autoimmune condition causing inflammation and damage to tissues around the eyes, leading to symptoms like bulging eyes, double vision, and vision loss. Current treatments, including glucocorticoids, often have limited efficacy or significant side effects, especially in moderate to severe active cases. This study aims to evaluate the efficacy and safety of a sequential treatment strategy combining glucocorticoids with IBI311, a novel anti-IGF-1R antibody, for patients who have not fully responded to initial glucocorticoid therapy.

As this is a recruiting study (NCT07152366), no results are available yet. However, the study aims to evaluate the efficacy and safety of the sequential treatment. Researchers will primarily assess the clinical activity score (CAS), expecting a significant reduction, and the overall response rate, aiming for a high percentage of patients achieving remission. They will also measure changes in proptosis (eye bulging) and diplopia (double vision) severity. > The primary outcome will be the percentage of patients achieving a clinical response, defined as a reduction in CAS by at least 2 points and no worsening of proptosis or diplopia, at 24 weeks post-treatment. Secondary outcomes will include the duration of response, the incidence of adverse events (AEs), and changes in quality of life scores, with an expected safety profile comparable to existing treatments. The study anticipates demonstrating a superior efficacy compared to glucocorticoids alone, with a lower recurrence rate over the 10-year follow-up period.