Photo Credit: Ablokhin
The following is a summary of “Efficacy and Safety of Teprotumumab in Patients With Thyroid Eye Disease of Long Duration and Low Disease Activity,” published in the October 2023 issue of Ophthalmology by Douglus et al.
Early Thyroid Eye Disease (TED) can lead to chronic proptosis (bulging eyes). Teprotumumab, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) inhibitor, shows promise in acute, high-inflammation TED, but its efficacy in chronic, low-activity cases remains unknown.
Researchers initiated a retrospective study to analyze data from the first placebo-controlled trial utilizing teprotumumab in chronic, low-disease-activity TED.
They initiated a double-masked, placebo-controlled trial across 11 US centers, enrolling adults with TED(2 to 10 years), Clinical Activity Score (CAS) ≤ 1 or no additional inflammation or progression in proptosis/diplopia for ≥1 year, proptosis ≥3 mm from before TED and/or from normal, euthyroid/mildly hypo/hyperthyroid, no prior teprotumumab, and no steroids within 3 weeks of baseline. Participants were randomly assigned to receive intravenous teprotumumab or placebo every three weeks for eight infusions in a 2:1 ratio. The main endpoint assessed proptosis (mm) improvement at Week 24, and AEs were monitored.
The results showed 62 patients (42 teprotumumab and 20 placebo) at week 24, teprotumumab showed greater least squares mean (SE) proptosis improvement (−2.41 [0.228]) compared to placebo (−0.92 [0.323]), with a difference of −1.48 (95% CI −2.28, −0.69; P = .0004).AE rates were comparable between groups. Hyperglycemia was observed in 15% vs. 10%, and hearing impairment in 22% vs. 10% with teprotumumab and placebo, respectively.AEs led to discontinuation in 1 teprotumumab (left ear conductive hearing loss with congenital anomaly) and 1 placebo patient (infusion-related), with no deaths reported.
They concluded that teprotumumab reduced proptosis in chronic, low-inflammation TED, proving effective regardless of disease duration or activity.
Source: academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgad637/7334391
