We've got a treatment for thyroid eye disease!
The FDA just approved teprotumumab (Tepezza), the first and only treatment for thyroid eye disease.
Let's take 30 seconds to talk this out from the top.
The pituitary gland produces thyroid stimulating hormone (TSH), which binds to receptors on the thyroid and produces two important thyroid hormones: T3 and T4. When the thyroid produces too much T3 and T4, bingo—hyperthyroidism. Although hyperthyroidism can have several causes, the most common cause is an autoimmune condition known as Graves disease.
Stay with me, we're getting to thyroid eye disease.
Hyperthyroidism causes cell growth, partly because of the excess hormones and partly due to the IGF-1 (insulin-like growth factor) pathway (remember this pathway for later). Growth of fat, muscle, and fibrous cells can lead to EOM swelling, which is one reason for the clinical manifestations we see in patients with thyroid eye disease.
So how does Tepezza work?
If you want to sound smart, Tepezza is a fully human monoclonal antibody and a targeted inhibitor of the IGF-1 receptor. In simpler terms, researchers discovered that by blocking the receptor for IGF-1, they could lessen the effect of this new cell growth. Reduced new cell growth means reduced EOM swelling.
What about the clinical trials?
The phase 3 trial found statistically significant improvements in proptosis and diplopia at 6 weeks of treatment, and those improvements continued over the 24-week treatment period. Read more about the trial here and scroll to the bottom of that page to see an example of a patient before and after treatment.
How is Tepezza administered?
By intravenous infusions. In the study, patients received an infusion once every 3 weeks for 21 weeks for a total of eight infusions.
Any adverse effects?
Yes, although the majority of them were graded as mild to moderate. The highest were muscle spasms in 32% of patients, but others included alopecia (20%), nausea (15%), and fatigue (12%). Ten percent of patients experienced diarrhea, headache, dry skin, and dysgeusia (distorted sense of taste), and five patients had hearing impairment, but all cases resolved. (via)
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See you next week!