CHICAGO — Teprotumumab, an IGF-1 receptor antagonist antibody, demonstrated improvement of double vision in patients with thyroid eye disease, according to a study presented here.
If approved by the FDA, teprotumumab (Horizon Pharma) would be the first drug with an indication for thyroid eye disease, Raymond S. Douglas, MD, PhD, said at the American Academy of Ophthalmology annual meeting.
In the phase 2 trial, 42 patients were treated with the study drug and 45 patients made up the placebo control arm. At week 24, which marked the end of the controlled trial, statistically significantly more patients taking the study drug achieved the primary endpoint of improvement in clinical activity score and reduction of proptosis (P < .001). Diplopia improvement was “impressive” at week 24, and of the patients with diplopia at baseline who did improve, 70% continued to have that improvement 48 weeks later, Douglas said.
The most reported adverse event was hyperglycemia, which returned to normal after discontinuation of the drug, he said.
“Teprotumumab ... appears to have stable improvement and durability of improving the double vision, proptosis and clinical activity in these patients and appears to reverse the effects of thyroid eye disease,” Douglas said. “The phase 3 trial will also have the added benefit of having a crossover group who will receive open-label therapy if [patients are] nonresponders at week 24, which ... may make this even more universally applicable to patients with long-standing disease.” – by Patricia Nale, ELS
Douglas RS. Diplopia response in a controlled trial with teprotumumab, an IGF-1 receptor antagonist antibody for thyroid eye disease. Presented at: American Academy of Ophthalmology annual meeting; Oct. 27-30, 2018; Chicago.
Disclosure: Douglas reports no relevant financial disclosures.