Terry J Smith1,2. 1. Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, Ann Arbor, Michigan, USA. 2. Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Abstract
BACKGROUND: Thyroid-associated ophthalmopathy (TAO), an autoimmune process affecting the tissues surrounding the eye, most commonly develops in individuals with Graves' disease. It is disfiguring, can cause vision loss, and dramatically lessens the quality of life in patients. There has been an absence of approved medical therapies for TAO with proven effectiveness and safety in multicenter, placebo-controlled, and adequately powered clinical trials. SUMMARY: The following is a brief overview of the rationale for developing a monoclonal antibody inhibitor of the insulin-like growth factor-I receptor into a treatment for TAO. This area of fundamental research has yielded an effective and safe medication, namely teprotumumab, based on two multicenter, placebo-controlled trials. Teprotumumab, marketed as Tepezza, has been approved recently by the US Food and Drug Administration for the treatment of TAO. Given its remarkable effectiveness, Tepezza is poised to become the first-line standard of care for TAO. KEY MESSAGES: Introduction of Tepezza into our armamentarium of therapeutic strategies for TAO represents a paradigm shift in the management of the disease. I proffer that the drug will replace glucocorticoids as a first-line treatment for TAO.
BACKGROUND: Thyroid-associated ophthalmopathy (TAO), an autoimmune process affecting the tissues surrounding the eye, most commonly develops in individuals with Graves' disease. It is disfiguring, can cause vision loss, and dramatically lessens the quality of life in patients. There has been an absence of approved medical therapies for TAO with proven effectiveness and safety in multicenter, placebo-controlled, and adequately powered clinical trials. SUMMARY: The following is a brief overview of the rationale for developing a monoclonal antibody inhibitor of the insulin-like growth factor-I receptor into a treatment for TAO. This area of fundamental research has yielded an effective and safe medication, namely teprotumumab, based on two multicenter, placebo-controlled trials. Teprotumumab, marketed as Tepezza, has been approved recently by the US Food and Drug Administration for the treatment of TAO. Given its remarkable effectiveness, Tepezza is poised to become the first-line standard of care for TAO. KEY MESSAGES: Introduction of Tepezza into our armamentarium of therapeutic strategies for TAO represents a paradigm shift in the management of the disease. I proffer that the drug will replace glucocorticoids as a first-line treatment for TAO.
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Authors: D G Maloney; A J Grillo-López; C A White; D Bodkin; R J Schilder; J A Neidhart; N Janakiraman; K A Foon; T M Liles; B K Dallaire; K Wey; I Royston; T Davis; R Levy Journal: Blood Date: 1997-09-15 Impact factor: 22.113
Authors: Terry J Smith; George J Kahaly; Daniel G Ezra; James C Fleming; Roger A Dailey; Rosa A Tang; Gerald J Harris; Alessandro Antonelli; Mario Salvi; Robert A Goldberg; James W Gigantelli; Steven M Couch; Erin M Shriver; Brent R Hayek; Eric M Hink; Richard M Woodward; Kathleen Gabriel; Guido Magni; Raymond S Douglas Journal: N Engl J Med Date: 2017-05-04 Impact factor: 91.245
Authors: Lelio Baldeschi; Antonella Lupetti; Phung Vu; Iris M M J Wakelkamp; Mark F Prummel; Wilmar M Wiersinga Journal: Ophthalmology Date: 2007-02-22 Impact factor: 12.079