This protocol addresses Graves' disease in patients who have developed active, moderate-to-severe thyroid eye disease (Graves' orbitopathy) — a clinical subset with significant orbital involvement that requires targeted first-line systemic intervention.

Clinical Scenario

Active moderate-to-severe thyroid eye disease involves meaningful orbital inflammation and functional impairment. Intravenous glucocorticoids are considered first-line therapy in this setting, and current guidelines support a combined treatment approach as the preferred strategy.

Treatment Approach (partial overview)

First-line management is built around intravenous glucocorticoid therapy, delivered as part of a structured multi-week course and combined with an additional immunosuppressive agent. The complete protocol — including sequencing, monitoring, and the full evidence-based regimen — is available via the link below.

Clinical Goals at 24 Weeks

Treatment response is evaluated at 24 weeks. Key targets include improvement in Clinical Activity Score (CAS), reduction in proptosis, and improvement in diplopia, visual acuity, and soft tissue swelling.

References

Intravenous glucocorticoids (IVGC) are considered first-line therapy in patients with moderate-to-severe TED.
The 2021 EUGOGO Clinical Practice Guidelines recommend combined use of IVGC and mycophenolate as first line therapy for active moderate-severe TED.
In a trial comparing mycophenolate mofetil 50 mg BID for 24 weeks with glucocorticoids 0.5 g IV daily for 3 days, followed by 60 mg oral daily for eight weeks and then tapered in 174 Chinese patients with active moderate-to-severe TED, the overall result was better with mycophenolate at 24 weeks (91.3% versus 67.9%) with concurrent improvement in 3 or more features including CAS, diplopia, proptosis, visual acuity, soft tissue swelling, or diplopia.

DOI: 10.1016/j.ecl.2021.12.004.

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Treatment of Graves' Disease with Active Moderate-to-Severe Thyroid Eye Disease

References