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The results of a phase 3 clinical trial show promise for successfully treating alopecia areata. Edward Berthelot/Getty Images

  • Autoimmune disease alopecia areata attacks the body’s hair follicles, causing hair loss.
  • There is currently no cure for alopecia areata, which affects 147 million people globally.
  • Researchers recently published promising results from a phase 3 clinical trial for possibly the first treatment for alopecia areata approved by the United States Food and Drug Administration (FDA).
  • The trial found that 1 in 3 patients with the condition were able to regrow hair after treatment with baricitinib — a drug normally used for rheumatoid arthritis.

New research from the Yale School of Medicine in New Haven, CT, found that 1 in 3 people with alopecia areata are able to regrow hair following treatment with an arthritis drug.

This study is part of phase 3 clinical trial for potentially the first FDA-approved treatment for the skin condition.

The results from this study appear in The New England Journal of Medicine.

Alopecia areata is an autoimmune disease that causes the body to attack hair follicles. The disease destroys hair follicles all over the body, causing hair loss.

People of any age, gender, and ethnic background may develop alopecia areata. However, it is more common for a person to develop alopecia areata before the age of 40.

According to the National Alopecia Areata Foundation, about 6.8 million people in the United States and 147 million people globally have or will develop the condition.

There is currently no cure for alopecia areata. Some people with mild forms of the disease may spontaneously regrow hair over time. Current treatments include corticosteroids, topical minoxidil (i.e. Rogaine), and immunosuppressive drugs.

A team of researchers led by Dr. Brett King, an associate professor of dermatology at the Yale School of Medicine recently published results from a phase 3 clinical trial.

The study examines the use of baricitinib — a prescription medication for the treatment of moderate to severe rheumatoid arthritis. Baricitinib is a Janus kinase (JAK) inhibitor, which disrupts the body’s ability to communicate with specific proteins called cytokines associated with inflammation.

“We think baricitinib works by interrupting the messaging between hair follicles and immune cells that lead to immune cells attacking hair follicles and ultimately hair loss,” Dr. King told Medical News Today.

“When the messaging is interrupted, the immune cells leave hair follicles alone and the hair follicles can do what they are supposed to, that is, grow hair.”

For the study, Dr. King and his team studied 1,200 people in two large, randomized trials. The study sponsor, American pharmaceutical company Eli Lilly, designed the study trials.

Study participants included both males and females over the age of 18. All participants had severe alopecia areata defined by a Severity of Alopecia Tool (SALT) score of 50 or higher. SALT ranges from a score of 0 with no hair loss from the scalp to 100, which is the complete loss of all hair from the scalp.

During the 36-week trials, participants received either 2 milligrams or 4 milligrams of baricitinib each day, or a placebo.

According to the study results, about 39% of Trial 1 participants and 36% of Trial 2 participants given the 4-milligram dose of baricitinib grew enough hair back to move to a SALT score of 20 or less by week 36.

Study results also showed possible side effects of using baricitinib as an alopecia areata treatment. According to researchers, the most common side effects among study participants were acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol.

“The clinical trials are ongoing and participants continue to be monitored, so we will have more and more safety data over time,” Dr. King said.

MNT also spoke with Dr. Amy McMichael, a dermatologist at Atrium Health Wake Forest Baptist in Winston-Salem, NC. She says this study is a long-time coming.

“It is a great outcome of great science that will ultimately change the lives of alopecia areata patients for the good. […] These trials tell us that there is finally enough understood about the mechanism of alopecia areata that we can block the immunologic process causing hair loss with an oral medication.”

– Dr. McMichael

“It also means that patients who have had the most resistant disease to other treatments and those with severe disease (as measured by SALT score of at least 50) now have an option that is likely going to work to improve their disease,” she continued.

For the next steps in this research, Dr. King said these clinical trials are ongoing. “Participants continue to be monitored for both efficacy and safety and so we will have more and more data in the months ahead,” he added.

And Dr. McMichael would like to see a better characterization of what lab monitoring is appropriate and the timing for these tests in patients.

“We also need to look at trials of the drug in children and adolescents with alopecia areata,” she said. “Finally, long-term studies are very important moving forward to make sure safety is measured for a disease that may require a long-term treatment.”