Terry J. Smith, MD
Shortage of Tepezza disrupts treatment of thyroid eye disease
Terry J. Smith, MD
The COVID-19 pandemic has abruptly affected drug manufacturing in the United States. This now includes the production of Tepezza, the only FDA-approved medical therapy for thyroid eye disease.
The temporary suspension has disrupted its supply chain, delaying the initiation of treatment of many patients in whom it is medically indicated. In addition, ongoing therapy with Tepezza (teprotumumab-trbw) has been interrupted. Horizon Therapeutics, the manufacturer of Tepezza, has publicly reported that this disruption in drug availability may extend through the first quarter of 2021. During this period, many of our patients with thyroid eye disease (TED) will continue to be confronted with delayed treatment.
Because of my deep involvement studying and treating TED, several colleagues have requested my personal advice concerning management of patients during this unfortunate disruption of Tepezza availability. Because Tepezza remains the only medical treatment for TED that reliably improves important aspects of its severity, including proptosis and diplopia, we must temporarily rely on traditional, albeit unapproved and unproven, drugs such as systemic glucocorticoids, rituximab, tocilizumab and mycophenolate. In my view, we must consider each patient individually and respond to their immediate medical needs with those treatment options currently available to us. For patients with moderate to severe active TED, those who are highly symptomatic and those with vision-threatening disease, a trial of high-dosage steroids may be appropriate. Glucocorticoids have been used for decades with some benefit in these patients, although clinical responses are unpredictable and may be complicated by side effects. Should these off-label treatments fail to sufficiently lessen disease symptoms, severity and activity, acute surgical options could be considered, especially in patients with unabated disease progression and evidence of vision loss.
With regard to deciding how to resume Tepezza treatment once the drug again becomes available, I will generally advise administration of the next scheduled dose and completion of the full eight infusion course that was used in both clinical trials. Further, the vast majority of real-world experience has involved eight infusions over 24-weeks. To my knowledge, there has been little experience with any material deviation from this course of Tepezza administration. Thus, the potential negative impact of fewer doses or reduced dosing on either completeness or durability of response is uncertain. It is unlikely that circumstances would justify repeating initial infusions in patients who have already begun therapy. Again, as stated earlier, the particular needs of each patient must be considered before any decisions are made concerning the medical management of individuals with TED. This includes deciding how to resume dosing patients with Tepezza. Strict adherence to best medical practices remains advisable in all circumstances.
To summarize, the delay in Tepezza availability has resulted in substantial concern among patients with TED and their doctors. Frequently asked questions pertain to whether this interruption might lessen effectiveness of the therapy or cause more side effects. While I cannot speak to the potential for TED progression or worsening during this period when Tepezza continues to be unavailable, the importance of frequent patient monitoring by health care providers cannot be overemphasized. Of note, immunogenicity of Tepezza has not been detected to date. Treating physicians are strongly advised to provide personalized guidance to their patients, regardless of whether completion of the full course has been interrupted or whether initiation of Tepezza therapy has been delayed.
Horizon Therapeutics is providing updated information through its website at www.horizontherapeutics.com. In addition, patients can reach out directly to support organizations such as the Graves’ Disease and Thyroid Foundation at www.gdatf.org.
- For more information:
- Terry J. Smith, MD, at Michigan Medicine Eye Plastic, Facial Cosmetic & Orbital Surgery, Kellogg Eye Center, University of Michigan Medical School, 1000 Wall St., Ann Arbor, MI 48105-1912; email: firstname.lastname@example.org. .