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ARTICLE | Clinical News

Teprotumumab meets in Phase II thyroid eye disease trial

May 11, 2017 10:20 PM UTC

Data published in The New England Journal of Medicine showed that teprotumumab (RV001), which Horizon Pharma plc (NASDAQ:HZNP) recently acquired, met the primary endpoint of a greater proportion of responders at week 24 compared to placebo in a Phase II trial to treat active thyroid eye disease (69% vs. 20%, p<0.001). A response was defined as achieving a reduction in clinical activity score of ≥2 points and a reduction in proptosis of ≥2 mm in the study eye.

Teprotumumab was well tolerated. The double-blind, international trial enrolled 88 patients with recent onset, moderate to severe thyroid eye disease to receive saline or IV teprotumumab every 3 weeks for a total of 8 infusions over 6 months. Quality of life (QOL) was a secondary endpoint in the trial...