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% FDA Approves Olumiant for Hair Loss From Alopecia Areata Everyday Health MenuNewslettersSearch Hair Loss
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Food and Drug Administration (FDA) approved the drug baricitinib (Olumiant) for severe alopecia areata (AA), an autoimmune disease that results in sudden and sometimes extreme hair loss. The once-a-day oral medication is the first FDA-approved systemic therapy for alopecia areata, meaning it treats the entire body rather than a specific area. Alopecia areata affects more than 300,000 people in the United States each year, often leading to bald patches on the scalp.
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People with severe alopecia areata may also lose eyebrows and eyelashes. “Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, MD, the director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in an FDA press release.
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“Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
Frustrated by the limited number of treatment options, many individuals with AA turn to wigs, false eyelashes, or eyebrow tattoos, says Lotus Mallbris, MD, the vice president of immunology development for Eli Lilly, the company that produces baricitinib. “People with alopecia areata face significant challenges, as the disease can be very stigmatizing,” Dr. Mallbris says.
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“With this approval, we now have a once-a-day medication that can help patients have significant hair growth and eyebrow and eyelash growth,” she says. Before the approval of baricitinib, there were zero FDA-approved therapies for the treatment of alopecia areata, says Kristen Lo Sicco, MD, associate professor of dermatology and the director of the skin and cancer unit at NYU Langone Medical Center in New York City. “This approval is huge, both for people with alopecia areata and the clinicians who have been advocating for them.
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It gives many patients better access to a medication that can help them get their hair back and improve their quality of life,” says Dr. Lo Sicco.
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Results from two phase 3 trials on baricitinib were published in The New England Journal of Medicine on May 5, 2022.
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A total of 1,200 people were included in the two trials: 51.7 percent of subjects were white, 36.3 percent were Asian, and 8.2 percent were Black. In both studies, participants were divided into three groups and received either 2 milligrams (mg) of baricitinib, 4 mg baricitinib, or placebo once a day, every day. To be included in the trial, people had to have severe alopecia, defined as at least 50 percent scalp hair loss for more than six months.
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In a pooled analysis of the two trials, patients had a mere 14.5 percent scalp hair coverage at the start of the study. The pooled analysis found that 39 percent of the people who took the 4 mg dose of baricitinib achieved significant scalp hair regrowth, defined as 80 percent or more scalp hair coverage. Reaching 80 percent scalp hair coverage is a dramatic improvement: At that point, the disease is no longer visible, says Mallbris.
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After a year, nearly 3 in 4 of those people achieved 90 percent scalp hair coverage. Lo Sico notes that 80 and 90 percent hair regrowth is a high bar that is set by the U.S. and European FDAs respectively.
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“Many patients are pleased when they have above 50 to 60 percent of hair coverage,” she says. Separately, more than 40 percent of study participants had full regrowth in eyebrow and eyelash hair or regrowth with minimal gaps. In the group that took 2 mg of baricitinib, 22.6 percent of participants reached the 80 percent threshold of hair growth.
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Separately, about 1 in 5 had regrowth in eyebrow hair and 1 in 4 had regrowth in eyelash hair. In many study participants who took the higher dose of baricitinib (Olumiant), hair loss was no longer visible.Massachusetts Medical Society
What Is Alopecia Areata
In people with alopecia areata, often referred to as simply “alopecia,” the immune system attacks hair follicles, causing inflammation and hair loss. As long as the immune system continues to attack the follicles, hair doesn’t grow back, according to the National Institutes of Health.
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In alopecia areata, many people lose clumps of hair in small circular patches about the size of a quarter. Hair loss typically begins suddenly, and people with the disease are usually healthy and have no other symptoms.
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Some people will go on to experience hair regrowth, while others will see additional bare patches develop, or small patches of hair loss join together and form larger areas of baldness. The condition, once relatively unknown, has been in the spotlight in the last few months.
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The actor and talk-show host Jada Pinkett Smith revealed she has alopecia and had made the choice to shave her head. Her husband, the actor Will Smith, slapped the comedian Chris Rock at the Academy Awards after Rock made a comment about Ms. Smith’s appearance.
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There are several forms of alopecia areata. Alopecia totalis involves total loss of hair on the head, while alopecia universalis causes complete loss of hair on the head, face, and body.
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Approval Helps Substantiate Alopecia Areata as a True Medical Condition
Historically, insurance companies have viewed hair loss as a cosmetic rather than a medical issue and used this rationale to deny coverage for treatment, says Lo Sicco. “That’s why this approval is so significant for this patient population — it helps substantiate alopecia areata as a true medical condition,” she says.
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Lo Sicco emphasizes that a patient’s decision about whether or not to pursue treatment for AA is a personal choice. “Most of the people who come to the clinic for their alopecia areata are interested in pursuing treatment to get their hair back, but I never press treatment on somebody,” she says.
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“It is my role as a clinician to provide information regarding therapeutic choices for my patients to make an informed decision regarding their AA treatment options.”
Baricitinib Works by Reducing Inflammation
Baricitinib is part of a class of drugs known as Janus kinase (JAK) inhibitors. JAKs are enzymes that transmit signals for cell processes, including immune response, stimulating immune cells to produce inflammatory proteins. JAK inhibitors interrupt the transmission of the signals and reduce inflammation.
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Researchers have been studying a number of JAK inhibitors as treatments for severe alopecia areata, including tofacitinib and ruxolitinib, according to the American Academy of Dermatology Association, which calls this a “major research breakthrough.” Baricitinib is the first JAK inhibitor to receive FDA approval for severe alopecia areata. People with alopecia areata have limited treatment options.
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Steroid injections to areas of hair loss can suppress the immune system so hair can regrow. Another therapy is the topical application of an irritant such as squaric acid, which creates a rash similar to poison ivy that distorts the immune system’s attack on the hair follicles, according to Yale Medicine.
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The FDA Has Also Approved Baricitinib to Treat People With RA and Hospitalized COVID-19 Patients
Baricitinib was approved by the FDA in 2018 to treat rheumatoid arthritis (RA), and it’s also been used to treat people who are hospitalized with COVID-19. Baricitinib was granted an emergency use authorization (EUA) in November 2020 to be used in combination with remdesivir for treating people 2 years old and older who are hospitalized with COVID-19 and who require supplemental oxygen or who are on a ventilator.
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In July 2021 the drug was granted an EUA to be used as a standalone treatment, and in May 2022, it was granted full approval, making it the first immunomodulatory treatment to receive FDA approval.
Common Side Effects and Warnings for People Taking Baricitinib
In both New England Journal of Medicine studies, baricitinib’s safety in treating alopecia areata was on par with that in patients who take the drug for rheumatoid arthritis.
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The most common side effects associated with baricitinib are upper respiratory tract infections, headache, acne, high cholesterol, increases in muscle-related blood markers (which can indicate muscle damage), urinary tract infection, liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (candida infections), anemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster), and weight increase. While the FDA has judged baricitinib to be safe and effective, the agency requires the medication to carry a black box warning for rare but potentially serious complications such as infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. A black box warning is the FDA’s most stringent warning for drugs and medical devices on the market.
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Each patient should talk to their doctor about their personal and family health history and specific risk factors when considering starting baricitinib for AA, says Lo Sicco.
How Much Will Baricitinib Cost
The list price of Olumiant is $2,497.20 for a 30-day supply of 2 mg tablets, but the actual cost of the drug for treating alopecia areata will vary according to the dose (2 mg or 4 mg) and insurance coverage.
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