A new consensus statement from the American Thyroid Association (ATA) and European Thyroid Association (ETA) offers recommendations for endocrinologists on the management of thyroid eye disease (TED), addressing key questions, including about important novel treatments, that transcend international borders.
The consensus statement is important as new therapies transform the treatment of TED that, notably, have even played a key role in simplifying the name of the disease, which has had numerous other, often confusing names over the years, ranging from thyrotropic exophthalmos to Graves ophthalmopathy, says Terry F. Davies, MD, of the Thyroid Research Unit, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York City, in an editorial published along with the statement in Thyroid.
“The emergence of novel therapies has changed the entire discussion concerning TED and not just its name,” he writes. “These are early and exciting days in the treatment of TED, which is likely to be a much more manageable disease in the years to come.”
However, Davies stressed to Medscape Medical News that there are still a lot of unanswered questions, particularly when it comes to newer therapies. For example, teprotumumab can cost up to $300,000 for one course of treatment for one patient, the consensus statement notes.
When to Consult an Ophthalmologist…
Graves disease is the most common cause of hyperthyroidism and affects > 1% of the US population. TED is the most common complication of Graves disease that occurs outside of the thyroid gland. TED causes a variety of eye-related signs and symptoms, which can be disfiguring and negatively affect quality of life, and in rare cases, threaten vision.
Key issues covered in the consensus statement include timely diagnosis of TED, assessment of disease activity and severity, initial care and referral for specialty care, and treatment recommendations for moderate to severe TED.
In terms of disease assessment, for instance, the statement authors note the important distinction in TED “between the two interdependent components of inflammatory activity, manifested by pain, redness, and edema, and disease severity, including proptosis, lid malposition, exposure keratopathy, impaired ocular motility, and optic neuropathy.”
“The presence of multiple features of inflammation usually signifies active disease,” they explain.
For initial care, input from endocrinologists as well as ophthalmologists with experience in TED management is urged, and “an ophthalmologist should be consulted when the diagnosis of TED is uncertain, in cases of moderate-to-severe TED, and when surgical intervention needs to be considered.”
Furthermore, “urgent referral is required when sight-threatening TED is suspected or confirmed,” the authors note.
Debate Over Some Treatment Recommendations
In terms of therapy, for initial care, “a single course of selenium selenite 100 μg twice daily for 6 months may be considered for patients with mild, active TED, particularly in regions of selenium insufficiency,” the consensus statement recommends.
Intravenous glucocorticoid (IVGC) therapy is meanwhile recommended as a preferred treatment for active moderate to severe TED specifically when disease activity is the prominent feature in the absence of significant proptosis or diplopia.
For patients with active moderate to severe TED who are glucocorticoid-resistant, the authors note that rituximab and tocilizumab may be considered and that teprotumumab has not been evaluated in this setting.
Teprotumumab, if available, is a preferred therapy for patients with active moderate to severe TED who have significant proptosis.
There is, however, some debate over the issue, editorial author Davies told Medscape Medical News.
“It is still argued over how bad the eyes need to be before recommending this new treatment,” he said. “I think the answer is in the proptosis — the amount of bulging present rather than just inflammation,” Davies said.
“There is also a real clinical problem in that we have no specific biomarker for the disease, however, high levels of TSH receptor antibody are often a good indicator of eye disease.”
The authors caution, however, that clinical trials with medical therapies have been limited by inclusion criteria and other factors, and biologics have meanwhile increased the cost of treatment “many-fold” compared with conventional agents.
Therefore, “clinicians should balance the demonstrated efficacy of recently introduced therapies [such as teprotumumab] against the absence of experience on sustained long-term efficacy, safety, and cost-effectiveness,” they note.
Importantly, “one course consisting of eight infusions of teprotumumab has a retail cost of approximately $300,000, depending on patient weight, [which is] approximately 2000 times that of IVGC,” they note.
“The process involved in selecting therapy with these drugs and other drugs includes a consideration of both short- and long-term efficacy, adverse effects that are both known and unknown, the likelihood of disease aggravation or relapse after a previously beneficial response, and the relative cost and availability,” said Henry B. Burch, MD, who is at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, in Bethesda, Maryland, and is on the consensus statement Task Force.
To help with those decisions, the consensus statement provides comprehensive tables that compare drug efficacy for key outcomes including inflammation, proptosis, diplopia, and quality of life, and importantly, comparisons also of drug costs and potential adverse effects for each of the current TED therapies.
Consensus Statement Not a Guideline
The groups note that the consensus statement is not meant to be a clinical practice guideline and was not written to “establish a standard of care, replace sound clinical judgment, or capture all nuances likely to be present in any particular patient,” and “specific outcomes are not guaranteed.”
What the statement is intended for is to “provide a concise and timely appraisal of a rapidly changing therapeutic arena” for practicing endocrinologists, they explain.
Overall, the authors recommend an individualized management approach, based on factors ranging from disease severity, duration, its impact on daily living, patient age, comorbidities, and importantly, the costs of therapies.
Ultimately, patient satisfaction is essential in TED management, Burch added.
“Consideration of the impact of TED on patient’s satisfaction with their appearance and visual functioning is a key component in management decisions concerning TED.”
Thyroid. Published online December 13, 2022. Consensus report, Editorial
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