Treatment of Active Moderate-to-Severe Graves’ Orbitopathy with Significant Proptosis or Diplopia
This protocol addresses the management of Graves’ orbitopathy in patients with active, moderate-to-severe thyroid eye disease (TED) presenting with significant proptosis and/or diplopia, for whom the impact on daily life justifies medical or surgical intervention.
Moderate-to-severe thyroid eye disease in the active phase, with significant proptosis of the eye and/or diplopia. Applies to patients without sight-threatening disease whose eye disease has sufficient impact on daily life to justify the risks of medical or surgical intervention.
When available, a targeted intravenous biologic therapy (teprotumumab) is the preferred first-line option. The protocol outlines alternative treatment strategies for situations where this therapy is unavailable or where the predominant clinical presentation calls for a different approach.
- Reduction in proptosis of ≥2 mm at 24 weeks
- Improvement in diplopia at 24 weeks
- Patients without sight-threatening disease whose eye disease has sufficient impact on daily life to justify the risks of medical or surgical intervention.
- TEP is a preferred therapy, if available, in patients with active moderate-to-severe TED with significant proptosis (see Section 2.1. for definition) and/or diplopia.
- In the OPTIC trial, a proptosis reduction of ≥2 mm (the study’s primary outcome) was achieved in 83% (34/41) of patients treated with TEP versus 10% (10/42) receiving placebo at 24 weeks, using an intention-to-treat analysis.
- Diplopia improved in 70% (46/66) of patients treated with TEP versus 31% (18/59) of patients given placebo.