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Teprotumumab for Treatment of Thyroid Eye Disease Meets Endpoints in Phase 3 Study
Results from the phase 3 OPTIC study showed more patients treated with teprotumumab had a meaningful improvement in proptosis compared with those who received placebo.
The confirmatory trial evaluated teprotumumab for the treatment of active thyroid eye disease.
The primary endpoint of the study was met, with 82.9% of 41 teprotumumab-treated patients achieving a 2 mm or more reduction of proptosis compared with 9.5% of 42 placebo patients, a statically significant difference (P < .001), according to a press release from Horizon Pharma.
All secondary endpoints were met in the study. A greater percentage of teprotumumab-treated patients experienced a 2 point or greater reduction in clinical activity score and a 2 mm or greater reduction in proptosis from baseline, with no deterioration in clinical activity score or proptosis in the fellow eye, compared with the placebo group.
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