Thyroid eye disease (TED), also known as Graves’ orbitopathy, is a complex immune-mediated disorder characterized by the aberrant proliferation of orbital fibroblasts, adipogenesis, glycosaminoglycan and mucin deposition. This connective tissue remodeling results in edematous, fibrotic adipose tissue and inflammation within the orbit and underlies the consequential classic presentation of proptosis, where the eyes appear pushed forward and bulge outward, due to primarily autoimmune-mediated hyperthyroidism.

Patients with TED may experience a range of symptoms, including eye pain, dry or gritty eyes, double vision, light sensitivity, and disfigurement. Predominantly affecting women, TED places a significant disease burden on 25-50% of patients with Graves’ disease and can profoundly impact their quality of life, making even daily activities like driving or working challenging, and in rare cases, can potentially lead to vision loss.

This article will explore new advancements that have been made in TED management since the publication of the American Thyroid Association’s 2022 Management of Thyroid Eye Disease Consensus Statement and 2016 Diagnosis and Management of Hyperthyroidism guidelines and speculate on potential evolutions in future TED Clinical Practice Guidelines in light of new FDA-approved medications and emerging updates.

Part 1 – Current TED Guidelines

To start, here is a listing of the current TED Consensus Statement/Guidelines in the US:

Part 2 – FDA Approvals Since the Most Recent Guidelines

The medications/therapies that have been approved by the FDA since the last TED Guideline:

TEPEZZA (teprotumumab-trbw)

  • Horizon Therapeutics (Acquired by Amgen in 2023)
  • TEPEZZA is a fully human IgG1 monoclonal antibody injection that acts as an insulin-like growth factor-1 (IGF-1) receptor inhibitor, indicated for the treatment of Thyroid Eye Disease.
  • In April 2023, the Food and Drug Administration (FDA) approved an update to the Indications and Usage section of the TEPEZZA label, specifying its application for the treatment of Thyroid Eye Disease, irrespective of disease activity or duration.

Part 3 – Predictions

Now that we’ve covered the current available TED guidelines, the “what’s changed” and new FDA approvals since the most recent 2022 publication, we can jump into the predictions. As a reminder, this is a list of predictions focused specifically on treatment of TED and including pharmacological treatments. These predictions are not based on specific guidelines or a specific organization, but instead provide broad, high-level predictions covering potential next guideline(s) on the topic of TED, regardless of which organization produces them.

Prediction 1

  • Tepezza was originally FDA approved in January 2020. It is the first and only medicine to receive approval from the FDA to treat TED in adults. With the recent label update and the ongoing establishment of its long-term safety profile, we anticipate that guidelines will soon recommend the use of Tepezza for all patients, regardless of disease activity or duration.

Prediction 2

  • Regarding Tepezza, it is important to note that it has not yet been approved for use in the European Union (EU). However, Amgen has initiated the approval process with the European Medicines Agency. We anticipate approval will be granted within the upcoming year.

Prediction 3

  • Thyroid eye disease presents a wide range of severity levels, clinical manifestations, and responses to treatment among patients. It is anticipated that a personalized medicine approach will be implemented to customize treatments according to these individual variations with the advancement of more targeted therapies and expanded understanding on its mechanism of action.

There you have it – an overview of the current TED consensus statements/guidelines, updates on recent major changes and FDA approvals that have happened since publication, and our informal, but evidence-based, predictions for what the next guidelines on thyroid eye disease may include. Once the next TED guideline update happens, we will compare our predictions to reality to see how we measured up. 

In the meantime, are there other topics you would like to see covered in a future guideline predictions series article? Contact us today and let us know! Until next time…

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