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Teprotumumab for Thyroid-Associated Ophthalmopathy
Terry J Smith1, George J Kahaly1, Daniel G Ezra1
1From the Department of Ophthalmology and Visual Sciences, Kellogg Eye Center (T.J.S., R.S.D.), and the Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine (T.J.S.), University of Michigan Medical School, Ann Arbor; the Department of Medicine, Johannes Gutenberg University Medical Center, Mainz, Germany (G.J.K.); Moorfields Eye Hospital, London (D.G.E.); the University of Tennessee Health Science Center, Memphis (J.C.F.); the Oculofacial Plastic Surgery Division, Oregon Health and Science University, Portland (R.A.D.); Eye Wellness Center, Neuro-Ophthalmology of Texas, Houston (R.A.T.); the Department of Ophthalmology, Medical College of Wisconsin, Milwaukee (G.J.H.); the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (A.A.), and the Endocrinology and Diabetology Unit, Fondazione IRCCS Ca' Granda, University of Milan, Milan (M.S.) - both in Italy; the Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles (R.A.G.); the University of Nebraska Medical Center, Omaha (J.W.G.); Barnes-Jewish Hospital, Washington University, St. Louis (S.M.C.); the Department of Ophthalmology, University of Iowa Hospitals and Clinics, Iowa City (E.M.S.); the Department of Ophthalmology, Emory University, Atlanta (B.R.H.); the Department of Ophthalmology, University of Colorado, Aurora (E.M.H.); and River Vision Development, New York (R.M.W., K.G., G.M.).
Teprotumumab, an inhibitor of the insulin-like growth factor I receptor (IGF-IR), significantly improved thyroid-associated ophthalmopathy compared to placebo. This novel therapy offers a promising new treatment for active, moderate-to-severe cases.
Area of Science:
- Ophthalmology
- Endocrinology
- Immunology
Background:
- Thyroid-associated ophthalmopathy (TAO), often linked to Graves' disease, has limited treatment options.
- Current therapies like glucocorticoids have restricted efficacy and safety concerns.
- Inhibiting the insulin-like growth factor I receptor (IGF-IR) presents a novel therapeutic strategy for TAO's autoimmune basis.
Purpose of the Study:
- To evaluate the efficacy and safety of teprotumumab, a monoclonal antibody targeting IGF-IR, in patients with active, moderate-to-severe TAO.
- To compare teprotumumab's effects against a placebo in a randomized, double-masked trial.
Main Methods:
- A multicenter, randomized, placebo-controlled trial involving 88 patients with active TAO.
- Patients received eight intravenous infusions of either teprotumumab or placebo every three weeks.
- Primary endpoint: reduction in Clinical Activity Score and proptosis at 24 weeks.
Main Results:
- 69% of patients receiving teprotumumab showed a response versus 20% on placebo at 24 weeks (P<0.001).
- Significant improvements were observed as early as week 6.
- Hyperglycemia was the only drug-related adverse event, manageable in diabetic patients.
Conclusions:
- Teprotumumab demonstrated superior efficacy over placebo in reducing proptosis and Clinical Activity Score in active TAO.
- The drug offers a new, effective treatment for active moderate-to-severe thyroid-associated ophthalmopathy.
- IGF-IR inhibition is a viable therapeutic approach for TAO.
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