FDA Approves Yale Roots Treatment for Alopecia Areata

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In a June 13 announcement, the US Food and Drug Administration approved the use of the Janus kinase (JAK) inhibitor baricitinib to treat severe alopecia areata, a disfiguring skin condition.

It is the first approved treatment for alopecia areata, an autoimmune disease that affects approximately 7 million people in the United States. The often disfiguring disease, in which the body’s immune system attacks hair follicles, is characterized by patchy or complete loss of the scalp and sometimes eyebrows, eyelashes, facial hair, and body hair.

DR board kingassociate professor of dermatology at Yale Medical School, worked with pharmaceutical company Eli Lilly and Company to conduct a series of clinical trials of the new drug, a once-daily pill called Olumiant.

In the studies, Olumiant helped one in three patients with severe alopecia areata regrow their hair – nearly half of the patients had no scalp hair at the start of the studies – resulting in 80% or more scalp coverage. Improvements were also achieved in patients with severe hair loss on eyebrows or eyelashes.

Over the past decade, King has conducted innovative research using JAK inhibitors — originally developed to treat rheumatoid arthritis and certain blood disorders — to treat a number of intractable skin conditions, including eczema, vitiligo, granuloma annulare, sarcoid, and erosive lichen planus. Earlier this year, the American Academy of Dermatology named King a “Hero in Patient Care.”

King spoke to Yale News about the new treatment, how it fits into his overall research efforts, and what it means for patients.

What does this FDA approval mean for patients in the practice for the treatment of alopecia areata?

Brett King: Until now, there have been no FDA-approved treatments for alopecia areata, and the drugs that have historically been used to treat severe cases of alopecia areata are largely ineffective. However, there is plenty of data showing that a relatively new class of drugs called JAK inhibitors are effective in treating severe alopecia areata. However, patient access to these drugs is extremely limited because JAK inhibitors have not been approved by the FDA for this purpose. FDA approval will give patients greater access through insurance coverage.

FDA approval also has an added benefit. When a drug is approved to treat a disease, doctors feel more comfortable prescribing the drug for that purpose. Therefore, FDA approval will enable healthcare providers to treat patients with severe alopecia areata.

How did you get into the baricitinib studies?

King: I had been very actively investigating the use of JAK inhibitors, primarily tofacitinib, for the treatment of patients with alopecia areata when Eli Lilly became interested in treating alopecia areata with baricitinib, so I became a key advisor to her in the development of these clinical trials.

Do you remember the first patient or group of patients you treated with JAK inhibitors?

King: I vividly remember the first patient I treated. He had almost no hair on his head, was missing eyebrows and eyelashes and facial hair, and had red, scaly psoriasis plaques all over his body. That was in 2013. The JAK inhibitor tofacitinib was a new drug, not in dermatology but in rheumatology, and not even a year old. There was data suggesting that JAK inhibitors could interrupt alopecia areata in mice with this condition, so I thought about using tofacitinib in a human with this condition. This had never been done before and there were no instructions on how to do it. I explained to the patient that using tofacitinib on him would be exploratory, and he agreed to try it. I had to fight his insurance to get him the drug but I got it. Shortly after he started taking tofacitinib, his hair started growing out. Not long after, I published the results of his treatment and history was made that changed this disease forever.

What was the initial reaction from colleagues when you explored this treatment approach?

King: A lot of people were very intrigued. Some wanted to be there. Some thought I was crazy for using a new drug that doesn’t really exist in dermatology on so many people. Others were intrigued and thought i was crazy But I was forced to do what I was doing because so many people were asking for help – literally, I received hundreds and hundreds of emails in the days and weeks after my work was published. I was amazed by the stories and how much suffering there was with this disease. I had to try to help.

What advice would you give to other physicians and researchers with novel treatment ideas?

King: Make an effort. Whether we succeed or not, the process is incredibly rewarding and well worth the painful challenges.

How important is this development for you personally?

King: I am delighted and deeply grateful to have been able to accompany this discovery from the very first patient to now when the treatment will be available to countless people. I celebrate my mother who worked tirelessly, cleaning toilets among other thankless jobs to give me opportunities to do what I have done. It is an incredible joy to see a hypothesis unfold and become a life-changing treatment for people. My mother would be delighted too.

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