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Teprotumumab more effective than placebo in treating active ophthalmopathy
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Teprotumumab may be an effective therapeutic strategy to inhibit the insulin-like growth factor 1 receptor and reduce proptosis in patients with thyroid-associated ophthalmopathy, according to a study.
The multicenter, double-masked, randomized, placebo-controlled trial included 87 patients with active moderate to severe ophthalmopathy, randomly assigned to treatment with placebo or teprotumumab (River Vision Development) administered intravenously once every 3 weeks for eight total infusions; 45 patients were in the placebo group and 42 in the teprotumumab group. The intervention lasted for 24 weeks.
Sixty-nine percent of patients in the teprotumumab group had a response at week 24 compared with 20% in the placebo group (P < .001). By week 6, 43% of patients in the teprotumumab group had a therapeutic response compared with 4% in the placebo group (P < .001).
The reduction in proptosis at weeks 6, 12, 18 and 24 was significantly higher in the teprotumumab group than the placebo group (P < .001); 40% of patients in the teprotumumab group experienced a reduction in proptosis of 4 mm or more compared with 0% of patients in the placebo group at week 24.
“At weeks 6, 12, 18 and 24, the reduction in the Clinical Activity Score in the teprotumumab group was also significantly greater than that in the placebo group (P < .001 for all comparisons), although this score also decreased markedly and progressively in the placebo group,” the study authors wrote.
At all time points, scores on the Graves’ ophthalmopathy-specific quality-of-life questionnaire were significantly increased in the teprotumumab group. – by Robert Linnehan
Disclosure: Smith reports grant support from River Vision Development Corporation during the conduct of the study and other support from River Vision Development Corporation outside the submitted work. Smith reports a patent related to the detection of antibody-mediated inflammatory autoimmune disorders (US 6936426), a patent related to the diagnosis and therapy of antibody-mediated inflammatory autoimmune disorders (US 7998681 and US 8153121) and a patent related to diagnostic methods relating to Graves’ disease and other autoimmune disorders (US 8178304 ). Please see the study for all other authors’ relevant financial disclosures.
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Smith TJ, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1614949.
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