Therapies for Thyroid Eye Disease Management
Recommended Medical Therapies for Thyroid Eye Disease
For mild TED, the recently published ATA/ETA Consensus Statement¹ recommends the use of selenium for a 6-month course, especially in selenium deficient areas, based on a randomized placebo controlled trial showing some quality of life and disease activity benefit.² Corrective surgery is considered for patients affected by the body-image effects of eyelid retraction and mild proptosis once the disease is proven to be stable and inactive.
Active systemic medical treatment is recommended for patients with moderate-to-severe disease. A range of options is available, including intravenous or oral glucocorticoids, with or without mycophenolate, rituximab, tocilizumab, or teprotumumab. The authors preferred intravenous glucocorticoids in active disease, where the goal is disease inactivation, and control of soft tissue changes. Teprotumumab was recommended in patients for whom the predominant concerns are diplopia and/or proptosis. Rituximab and tocilizumab are considered acceptable alternatives, or second-line treatments. Intravenous glucocorticoids in a “rescue” protocol are recommended for TED-related optic nerve compression.³
Thyroid Eye Disease Treatment Approaches
There are no head-to head comparisons between the two predominant treatment options, intravenous glucocorticoids (IVGC) and teprotumumab. Teprotumumab has shown an unprecedented effect in decreasing proptosis and a significant improvement of diplopia,⁴ an effect that was not observed in a metanalysis of IVGC studies.⁵ Therefore, this medication should be used in patients in whom proptosis is a predominant component of TED, especially if diplopia is also present.
The ATA/ETA Consensus Statement considers glucocorticoids first choice when the main goal is “inactivation” of the disease and improvement of soft tissue changes. In the only (small) placebo-controlled trial of intravenous glucocorticoids, clinical activity score (CAS) dropped by ≥ 3 points in 4/6 patients in the treatment group vs. 1/9 in the placebo group. Soft tissue swelling improved in 3/6 treated patients and in 1/9 placebo patients.⁶ In the Phase 3 trial of teprotumumab, 59% of patients achieved a CAS of ≤ 1, a comparable ratio, given that the required CAS for inclusion was ≥ 4.⁷ This limited set of data suggests that the two drugs have comparable effect on CAS. The recommendation therefore reflects the wider availability of intravenous glucocorticoid (IVGC) treatment and its much lower cost.
How to Determine Appropriate Treatment
A complete and detailed clinical evaluation of the patient and of the protean manifestations of TED remain the basis for a correct decision process. However, external geographical and financial factors limiting the availability of teprotumumab are expected to continue to play a role in the decision process.
Key Updates in Thyroid Eye Disease Management
The effort made by the authors in summarizing the fragmented evidence available in this field in a single, readily accessible, and well-referenced document is to be highly commended. It is important to acknowledge that the authors managed to reconcile different perspectives from North America and Europe. The greatest innovation in the document is the assignment of somewhat different, if tentative, roles for IVGC and teprotumumab. This field is moving rapidly with novel indications for available drugs being sought and new drugs entering clinical trials, so expect these recommendations to need an update soon.
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