This protocol targets patients with active moderate-to-severe thyroid eye disease (TED) in whom heightened disease activity is the central clinical concern — specifically in the absence of significant proptosis and the absence of diplopia.
Active moderate-to-severe Graves' orbitopathy with sufficient impact on daily life to justify medical intervention. Disease activity is the prominent feature. There is no significant proptosis and no diplopia. The presentation falls outside sight-threatening categories but warrants targeted systemic treatment.
Intravenous glucocorticoid (IVGC) therapy is the preferred treatment in this setting. The complete structured regimen — including the specific schedule, monitoring criteria, and decision points — is available through the full protocol below.
Improvement in clinical activity score by more than 2 points and disease inactivation (CAS ≤2).
Patients without sight-threatening disease whose eye disease has sufficient impact on daily life to justify the risks of medical or surgical intervention.
IVGC therapy is a preferred treatment for active moderate-to-severe TED when disease activity is the prominent feature in the absence of either significant proptosis (see Section 2.1. for definition) or diplopia.
Standard dosing with IVGC consists of intravenous methylprednisolone (IVMP) at cumulative doses of 4.5 g over ~3 months (0.5 g weekly × 6 weeks followed by 0.25 g weekly for an additional 6 weeks).
Finally, in an RCT involving 159 patients with active moderate-to-severe TED, comparing three IVGC cumulative doses of 2.25, 4.98, and 7.47 g, improvement in CAS >2 points was found at 12 weeks in 81–83% using the two higher dose regimens and 58% of the low-dose treated patients.
Disease inactivation (defined in this study as CAS ≤2) occurred in 45–65% of patients.
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