FDA Approves Olumiant, a New Drug to Treat Alopecia Areata

FDA Approves Olumiant, a New Drug to Treat Alopecia Areata

Olumiant (baricitinib) — a drug used primarily to treat rheumatoid arthritis and other autoimmune diseases — was approved by the U.S. Food and Drug Administration (FDA) on Monday to regrow hair loss in patients with severe alopecia areata.

The oral medication, made by Eli Lilly, is the first systemic treatment (meaning it treats the entire body rather than a specific area) for the autoimmune skin disease.

“For the first time, we have truly amazing data showing that [for] 40% or perhaps more people who suffer from severe alopecia areata, there is treatment,” said study lead author Brett King, MD, associate professor of dermatology at Yale School of MedicineThe health. “This is truly historic because before 2014 no one thought this disease could be effectively treated.”

Alopecia areata occurs when the immune system attacks its own hair follicles, causing hair loss, usually on the scalp and face. In some cases, hair loss is more severe and widespread. According to the National Organization for Rare Disorders, approximately 2.5 million people in the United States live with alopecia areata. To date, no other treatment has been approved specifically for this condition, although medications can be used off-label to treat it.

“Access to safe and effective treatment options is critical for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, MD, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research, in a press release. “[The] approval will help address a significant unmet need for patients with severe alopecia areata.”

Here's what you should know about Olumiant, including how it works and who it's intended for.

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How Olumiant works

Olumiant is a Janus kinase (JAK) inhibitor; It works by blocking activity in one or more enzymes of a particular family, also known as Janus kinases. In patients with alopecia areata, JAK inhibitors silence the inflammatory chemicals produced around the hair follicle, allowing the inflammation to subside and the hair follicle to grow normally, said Melanie Palm, MD, a board-certified dermatologist at Art of Skin MDThe health.

FDA approval was based on Olumiant's safety and effectiveness in two Phase 3 clinical trials published in MayNew England Journal of Medicine. In both studies, researchers examined 1,200 adult patients with severe alopecia areata, which is defined as scalp hair loss of at least 50% according to the Severity of Alopecia Tool. According to Dr. These are people who have lost at least half or all of their head hair (alopecia universalis) for more than six months.

Patients were randomly assigned to one of three treatment options: a tablet containing 2 milligrams of Olumiant, 4 milligrams of Olumiant, or a placebo once daily. Researchers measured success by how many patients saw at least 80% hair coverage on the scalp after 36 weeks of treatment.

About 39% of patients who received the 4-milligram dose of Olumiant in the first study (BRAVE-AA1) saw complete or near-complete hair coverage after 36 weeks of treatment; In the second study (BRAVE-AA2), 36% of patients saw the same results at the same dose. Even patients taking the 2-milligram dose saw much better hair growth results compared to placebo (23% vs. 6%; 19% vs. 3%).

“This is an incredible advance toward an approved treatment that can help relieve the distress and suffering of patients with alopecia areata,” said study co-author Justin Ko, MD, clinical professor of dermatology at Stanford MedicineThe health. “Some of the patients I have treated successfully find that by growing their hair back, they feel like themselves again and have gotten their life back.”

Side effects associated with Olumiant were also mild or moderate, researchers said. Acne was more common in patients receiving baricitinib than placebo, as were urinary tract infections. Other common side effects include: headache, certain infections (upper and lower respiratory tract infections, fungal infections), and folliculitis (inflammation of hair follicles). The drug is also not recommended for use with other JAK inhibitors or types of immunosuppressants.

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Other treatments for alopecia areata

Olumiant is the first FDA-approved treatment for alopecia areata - specifically for use in serious conditions. However, some current treatments (although not FDA-approved) are known to help people with milder forms of the disease.

Corticosteroids — topical, intralesional and systemic — may be helpful in some patients, said Brittany Craiglow, MD, associate professor of dermatology at Yale School of MedicineThe health. Other treatments such as immunotherapy or solutions to stimulate hair growth may also be helpful in milder cases.

“The more severe a patient is, the less chance there is of improvement with what we have in our toolbox now,” said Dr. Craiglow. “Currently available therapies are not reliably effective, particularly for more serious illnesses.”

Two other pharmaceutical companies – Pfizer and Concert Pharmaceuticals – are also testing their own JAK inhibitors to treat alopecia areata.

Despite these promising treatments on the market (or soon to be on the market), patients should still seek the advice of a dermatologist or other healthcare provider if they suspect they are dealing with any form of alopecia, Stephanie Travato, MD, a board-certified dermatologist and assistant professor of dermatology at The Ohio State University Wexner Medical Center, toldThe health.

Because the severity of alopecia areata varies from person to person, there are also different treatment options - meaning that what works for one person may not work for another. “The good news is that it is not a permanent form of hair loss,” said Dr. palm. “If we can calm the noise around the hair follicle, the hair can grow back.”

Although Olumiant is now approved by the FDA, researchers say studies for the drug are ongoing and are expected to last up to 200 weeks to further assess safety and effectiveness. But overall, Olumiant's FDA approval — and the promise of other drugs in the pipeline for alopecia areata — is promising for the community as a whole.

"It's terrible not knowing if you're going to wake up tomorrow and you're missing an eyebrow. It's terrible not knowing if you're going to wake up tomorrow and literally your entire head of hair is going to be on the pillowcase," King said, adding that it's "incredibly exciting" to have a treatment available now.