Topline data shows efficacy of teprotumumab in longer disease duration in patients with thyroid eye disease
Topline data from 2 clinical trials show that teprotumumab-trbw (Tepezza; Horizon Therapeutics) is safe and effective efficacy for the treatment of thyroid eye disease, according to a press release.
Teprotumumab-trbw is the only medication approved by the FDA for the treatment of thyroid eye disease.
In the OPTIC Phase 3 confirmatory clinical trial, patients with thyroid eye disease were treated with Teprotumumab-trbw or placebo once every 3 weeks for a total of 8 infusions over 24-weeks and a 48th-week off-treatment follow-up period, without receiving any treatment for thyroid eye disease.
The OPTIC-X open-label extension clinical trial included patients who were enrolled in the OPTIC clinical trial and were proptosis non-responders at Week 24 of OPTIC, or were proptosis responders at Week 24 but relapsed during the 48-week off-treatment follow-up period.
The majority of patients (89%) who received placebo during OPTIC and then received Teprotumumab-trbw during the OPTIC-X trial achieved the primary endpoint of a 2 mm or more reduction in proptosis at Week 24 (average reduction of -3.5 mm).
“Data from OPTIC-X provide evidence supporting the potential for Tepezza to meaningfully reduce proptosis in patients who have had thyroid eye disease for a longer period of time than what was originally studied in the Phase 2 and Phase 3 clinical trials,” said Elizabeth H.Z. Thompson, PhD, group vice president, development and external search, research and development, Horizon, in a release. “It is also promising to see that there are patients who may benefit from additional therapy with Tepezza, and the data suggest that they can experience these improvements without added safety concerns. We look forward to continuing our development program and further understanding the efficacy and safety of Tepezza among patients who are at various stages of their thyroid eye disease journey, from early diagnosis to chronic (inactive) patients.”
Read the full press release here.