Press Release Meetings & Events

First FDA-approved drug for thyroid eye disease effective regardless of age, gender

Washington, DC March 31, 2020

Teprotumumab, the first FDA-approved medicine for thyroid eye disease, provides significant improvement in eye bulging, regardless of patient gender, age or smoking status, according to a study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society. 

Though it is a rare condition, thyroid eye disease is devastating to those who have it, affecting their relationships with family, friends and co-workers. Until recently, no medicine was approved by the U.S. Food and Drug Administration for the treatment of thyroid eye disease. Teprotumumab was approved by the FDA in January 2020.

“Teprotumumab decreases inflammation in the eye and the build-up of tissues behind the eye that produce the long-term symptoms that reduce quality of life for patients with thyroid eye disease,” said lead researcher George J. Kahaly, M.D., Ph.D., of Johannes Gutenberg University Medical Center in Mainz, Germany. “It offers thyroid eye disease patients new hope.”

The disease is associated with the outward bulging of the eye that can cause a variety of symptoms, such as eye pain, double vision, light sensitivity or difficulty closing the eye. The symptoms can lead to the progressive inability to perform important daily activities, such as driving or working. Thyroid eye disease affects more women than men.

The researchers analyzed data from two 24-week studies, with a total of 171 patients with thyroid eye disease. Prior analyses of these studies showed 77.4% of patients had a reduction in eye bulging, compared with 14.9% of those receiving a placebo, after 24 weeks of therapy. The researchers performed the new analysis to see whether patients’ gender, smoking status and age influenced the drug’s response rate.

The participants were randomly assigned to receive teprotumumab or a placebo. At week 24, significantly more patients receiving teprotumumab had improvements in their eye bulging compared with those who received a placebo, regardless of their gender, smoking status or age: (male: 73.1% vs. 5.0%, female: 79.3% vs. 17.9%; smokers: 70.0% vs. 23.1%, non-smokers 79.7% vs. 11.5%; younger than age 65: 76.1% vs. 16.2%, age 65 or older: 84.6% vs. 7.7%).

The average reduction in eye bulging was also significantly greater after 24 weeks of treatment in all subgroups of patients treated with teprotumumab compared with the placebo group.

The trial was sponsored by Horizon Therapeutics, plc.

The Endocrine Society canceled its annual meeting, ENDO 2020, amid concerns about COVID-19. Visit our online newsroom for more information on accepted abstracts, which will be published in a special supplemental section of the Journal of the Endocrine Society.

###

Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.


All Press Releases

Media Contacts

Colleen Williams Manager, Public Relations Phone: (202)-971-3611 [email protected]

Jenni Glenn Gingery Associate Director, Communications and Media Relations Phone: (202)-971-3655 [email protected]

All News & Advocacy

Hill Event
Patient Resources

The Hormone Health Network

Hormone Health Network
From bench to bedside and all the stages in between, the Hormone Health Network is committed to supporting patient and public education.

From bench to bedside and all the stages in between, the Hormone Health Network is committed to supporting patient and public education.

Podcast

Endocrine News Podcast

EndocrineNewsPodcast
The Endocrine News podcast brings you the latest research and clinical advances from experts in the field, whether you are in your car, office, or out for a run.

The Endocrine News podcast brings you the latest research and clinical advances from experts in the field, whether you are in your car, office, or out for a run.

Bench to Bedside

Endocrine Society Journals

Research
Our top-ranked peer-reviewed journals are among the first to publish major developments and discovery milestones.

Our top-ranked peer-reviewed journals are among the first to publish major developments and discovery milestones.

Back to top
Short on time?

We'll come to you...

Get updates on the latest breakthroughs, clinical practice guidelines, and career development opportunities, straight to your inbox

Then take the next step: Set up your free website account and get exclusive access to even more great tools & content!