Liu, Catherine Y.

Purpose: This study assesses intersurgeon variability in proptosis reduction after orbital decompression for thyroid eye disease. Methods: This multicenter retrospective study included patients with thyroid eye disease who underwent orbital decompression from 1 of 7 surgeons at 7 different institutions between January 2002 and December 2018. Data were included if a single decompression technique was performed on ≥10 patients by ≥2 surgeons. The primary outcome was postoperative change in proptosis with emphasis on comparison among surgeons utilizing similar surgical techniques. Statistical analysis was performed with χ 2 and ANOVA testing, and a multivariable logistic regression model was generated. Results: Six hundred thirty-three orbits that underwent orbital decompression were included. Five different decompression techniques were analyzed: medial wall (n = 29), fat + lateral wall (n = 113), medial wall + floor (n = 123), fat + lateral wall + medial wall (n = 140), and fat + lateral wall + medial wall + floor (n = 228), without significant difference in proptosis reduction among surgeons. Surgeons did not demonstrate significant differences in outcomes at different time points compared with each other or themselves. Outcomes when comparing endoscopic versus open medial wall decompression varied among surgery types. Multivariate modeling revealed a statistically significant association between postoperative change in proptosis with preoperative proptosis ( p < 0.001). Conclusions: Postoperative change in proptosis did not differ significantly between surgeons utilizing similar orbital decompression techniques for patients with thyroid eye disease. This study may strengthen the statistical validity of multicenter clinical trials assessing orbital decompression outcomes performed by surgeons employing uniform surgical techniques, thereby advancing our understanding of optimal surgical management strategies for thyroid eye disease.

AbstractContextEarly inflammatory thyroid eye disease (TED) can lead to symptomatic chronic disease, including disabling proptosis. Teprotumumab, an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, previously demonstrated efficacy in acute, high-inflammation TED trials.ObjectiveWe present data from the first placebo-controlled trial with teprotumumab in chronic/low disease activity TED.MethodsThis randomized double-masked, placebo-controlled trial, conducted at 11 US centers, enrolled adult participants with TED duration of 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. Patients received (2:1) intravenous teprotumumab or placebo once every 3 weeks (total 8 infusions). The primary endpoint was proptosis (mm) improvement at Week 24. Adverse events (AEs) were assessed.ResultsA total of 62 (42 teprotumumab and 20 placebo) patients were randomized. At Week 24, least squares mean (SE) proptosis improvement was greater with teprotumumab (−2.41 [0.228]) than with placebo (−0.92 [0.323]), difference −1.48 (95% CI −2.28, −0.69; P = .0004). Proportions of patients with AEs were similar between groups. Hyperglycemia was reported in 6 (15%) vs 2 (10%) and hearing impairment in 9 (22%) vs 2 (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). There were no deaths.ConclusionTeprotumumab significantly improved proptosis vs placebo in longstanding/low inflammation TED, demonstrating efficacy regardless of disease duration/activity. The safety profile was comparable to that previously reported.