Michael Kazim, Lelio Baldeshi, A Augusto Cruz, Peter J Dolman, Chrysoula Dosiou, Anja Eckstein, Don Kikkawa, Andrea L Kossler, Louise A Mawn, Naykky Singh Ospina, Petros Perros, Daniel B Rootman, Mario Salvi, Marius N Stan, Timothy J Sullivan, Sara T Wester
To best evaluate and use potential new therapeutic agents for TED, physicians with expertise in the field perceive the need for a novel set of metrics. The outlined Innovate TED Initiative can, through the design and execution of prospective validation studies, develop the requisite metrics for the mutual benefit of physicians, regulatory bodies, the pharmaceutical industry, and patients with TED.
IMPORTANCE: Advances in the understanding of the pathophysiology of thyroid eye disease (TED) provide an opportunity to use novel, targeted therapeutic agents. However, our capacity to assess the efficacy and indications for the new agents is potentially limited by the clinical metrics used in recent research trials, which fail to adequately capture the clinical complexity and diversity of TED.
OBJECTIVES: To review the features of TED that make it atypical among autoimmune diseases, review the limitations of the currently available metrics, and introduce the Innovate TED Initiative to develop new outcome metrics.
CONCLUSIONS AND RELEVANCE: To best evaluate and use potential new therapeutic agents for TED, physicians with expertise in the field perceive the need for a novel set of metrics. The outlined Innovate TED Initiative can, through the design and execution of prospective validation studies, develop the requisite metrics for the mutual benefit of physicians, regulatory bodies, the pharmaceutical industry, and patients with TED.