FDA approves Olumiant to treat severe cases of alopecia areata

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FDA approves Olumiant for the treatment of severe alopecia. Image credit: Wirestock Creators/Shutterstock.
  • The Food and Drug Administration (FDA) originally approved Olumiant (baricitinib) in 2018 to treat rheumatoid arthritis.
  • The approval of Oluminant reportedly marks the first time the FDA approved a “systemic treatment” for this form of alopecia.
  • Olumiant is available in tablet form and is a daily medication.

There are several forms of alopecia, including alopecia areata, an autoimmune skin disease that causes bald patches. According to the American Academy of Dermatology Association (AAD), the immune system attacks the hair follicles, which leads to hair falling out.

The National Organization for Rare Disorders reports that alopecia areata affects around 2.5 million Americans. While many people experience mild cases of alopecia and only have one or two bald patches, others develop more severe cases and have a significant amount of hair loss.

People can develop alopecia at any time in their lives, but the AAD indicates that most people who have it first see symptoms by the time they are 30 years old.

While there is no cure for alopecia, there are some treatments available that can stimulate hair growth.

Corticosteroids can either be injected into the affected area or applied as a topical treatment. Doctors often prescribe topical corticosteroids to younger people with alopecia.

Another treatment is immunotherapy. According to the National Alopecia Areata Foundation, this treatment “causes an allergic rash (allergic contact dermatitis) that looks like poison oak or ivy, which ages the immune response.”

Finally, there is another type of drug called Janus kinase (JAK) inhibitors. JAK inhibitors treat a variety of inflammatory diseases.

The FDA has now approved another such drug, called Olumiant, traditionally used in the treatment of rheumatoid arthritis, for the treatment of alopecia areata.

cytokines, which are proteins involved in cell signaling, play a role in autoimmune diseases. When the body produces an excessive amount of cytokines, this can dysregulate the immune system.

Oluminant works by interrupting cytokine cell signaling as well as the signaling pathways of enzymes.

This affects the body by lowering its immune system. As a result, Olumiant creates an opportunity for the body to start growing hair again.

The FDA based its approval on two recent phase 3 trials, THRIVE-AA1 and THRIVE-AA2 that Olumiant manufacturer Eli Lilly conducted.

Participants had to have a severe case of alopecia to participate in the trials, with at least a 50% hair scalp loss occurring for at least 6 months.

Both trials consisted of three groups each. The first group received a 2-milligram (mg) daily dose of Oluminant, the second group received 4 mg of Oluminant daily, and the third group received a daily placebo.

The goal was for the participants to see “adequate scalp hair coverage,” which researchers defined as having at least 80% scalp hair coverage by week 36 of the trial.

Of the participants in the first trial, 22% who took 2 mg of Olumiant, and 35% of participants who took 4 mg saw adequate coverage. Of the placebo group, 5% had adequate coverage.

The results were slightly lower for the second trial.

Of the participants who took 2 mg of Olumiant, 17% saw adequate scalp hair coverage. Of the participants who took 4 mg, 32% saw adequate coverage, and 3% of the participants who took a placebo saw adequate coverage.

Olumiant reports a number of common side effects, including:

The drug also comes with a boxed warning that notes the medication can cause serious issues, such as tuberculosis. Additionally, Oluminant can cause people to have a higher risk for cancer, heart attacks, and strokes.

During the Olumiant trials, only 2.2% of participants quit due to adverse reactions.

dr Ken L. Williams Jr., surgeon and founder of Orange County Hair Restoration in Irvine, CA, spoke with Medical NewsToday about the FDA’s approval of Olumiant for alopecia areata.

dr Williams said that for patients with more advanced forms of alopecia who have emotional difficulty with the disease, “consideration of this medication for certain patients may be warranted.”

dr Williams also expressed some concerns about Olumiant and how it can possibly affect one’s health.

“This medication decreases a human’s ability to fight infections,” Dr. Williams said. “Other important serious side effects of immunosuppression are tuberculosis and susceptibility to environmental pathogens such as bacteria, fungi, and viruses.”

The doctor also noted that such infections can potentially be fatal.

“In my opinion, for the more common clinical presentation of alopecia areata such as localized patches of hair loss, the potentially serious effects of this medication limits its use,” commented Dr. Williams.

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