Phase II and III clinical trials of Tepezza shows reduction in proptosis in thyroid eye disease.- Horizon Therapeutics

Horizon Therapeutics announced new pooled efficacy data from the Phase II and III clinical trials of Tepezza (teprotumumab-trbw) showing that the recently approved medicine effectively reduces proptosis (eye bulging) in patients with Thyroid Eye Disease (TED) regardless of age, gender and smoking status. Prior analyses of combined data from two 24-week, randomized, double-masked, parallel-group clinical trials (Phase II and Phase III) for Tepezza have demonstrated a proptosis response (at least 2 mm reduction) rate of 77.4 percent in Tepezza patients compared to only 14.9 percent in placebo patients (p<0.001) at Week 24.

This new analysis was conducted to determine if there are any differences in proptosis response based on patient demographic characteristics, including age, gender and smoking status. At Week 24 of treatment, across all subgroups, significantly more patients receiving Tepezza (n=84) experienced an improvement of at least 2 millimeters in proptosis compared to those receiving placebo (n=87) (p<0.001 for all). For younger than age 65 (n=145): 76.1% vs. 16.2%. For age 65 and older (n=26): 84.6% vs. 7.7%. For male (n=46): 73.1% vs. 5.0% and for female (n=125): 79.3% vs. 17.9%. For smokers (n=46): 70.0% vs. 23.1% and for non-smokers (n=125): 79.7% vs. 11.5%. The mean reduction in proptosis from baseline was also significantly greater at Week 24 in Tepezza-treated patients compared to placebo-treated patients (male: -3.34 vs. -0.07 mm; female: -3.10 vs. -0.42 mm; smokers: -2.99 vs. -0.72 mm; non-smokers: -3.20 vs. -0.31 mm; younger: -3.10 vs. -0.39 mm; older: -3.55 vs. -0.22 mm; all p<0.001).

The majority of adverse events experienced with Tepezza were manageable in the trials, with few discontinuations or therapy interruptions. The analysis was accepted for presentation during an oral session at ENDO 2020, the Endocrine Society’s annual meeting, and will also be published in a special supplemental section of the Journal of the Endocrine Society.