gms | German Medical Science

Objective: Type I phenotype thyroid eye disease (TED) is typically thought to occur in younger patients with proptosis due to orbital fat expansion, absence of restrictive myopathy, and low rates of dysthyroid optic neuropathy (DON). In contrast, type II TED affects older patients and is characterized by presence of restrictive myopathy, higher rates of DON and diplopia and. We assessed the teprotumumab efficacy in patients with type I and type II TED.

Methods: In this post hoc analysis, we included data of teprotumumab-treated patients from four trials: Acute TED patients from the phase 2 and OPTIC study had a clinical activity score (CAS)≥4 and TED duration ≤9 months and OPTIC placebo patients who received teprotumumab in OPTIC-X. Patients from the phase 4 study had longer TED duration (≥2 to <10 years) and CAS≤1. We assumed patients ≥40 and <40 years of age to have type I and type II TED, respectively. We evaluated proptosis response (=2 mm improvement), proptosis least squares mean (LSM) change, diplopia response (≥1 Gorman grade improvement) and Graves’ orbitopathy quality of life (GO-QOL) LSM change at week 24.

Results: 121 patients had acute TED. In patients ≥40 (n=99), mean age was 54.5 years, 72.7% were female, and 74.7% had diplopia. In patients <40 (n=22), mean age was 32.8, 59.1% were female, and 68.2% had diplopia. In patients ≥40 and <40, 79.8% and 86.4% (P=0.602) were proptosis responders, respectively, 66.2% and 73.3% were diplopia responders (P=0.619), and proptosis LSM change was -3.22 and -3.46 mm (P=0.525). Total GO-QOL LSM change was 15.96 and 19.09, respectively (P=0.446).

Forty-two patients had longer duration TED. Of 29 patients ≥40, mean age was 56.1, 75.9% were female, 34.5% had diplopia, and 20.7% had constant diplopia. Of 13 patients <40, mean age was 32, 76.9% were female, 30.8% had diplopia, and none had constant diplopia. Proptosis response was observed in 62.1% and 61.5%, respectively (P=1), diplopia response in 40% and 50%, (P=1), and LSM proptosis change was -2.60 and -2.00 mm (P=0.275). GO-QOL Appearance subscore LSM change was 8.32 and 12.95, respectively (P=0.625); Visual functioning LSM change was 8.68 and 5.00, respectively (P=0.158).

Conclusion: Comparable efficacy was observed with teprotumumab in patients with both acute and longer duration disease who were assumed to have type I and type II TED