The condition, once relatively unknown, has been in the spotlight in the last few months. 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. Hair loss typically begins suddenly, and people with the disease are usually healthy and have no other symptoms. In alopecia areata, many people lose clumps of hair in small circular patches about the size of a quarter. As long as the immune system continues to attack the follicles, hair doesn’t grow back, according to the National Institutes of Health. In people with alopecia areata, often referred to as simply “alopecia,” the immune system attacks hair follicles, causing inflammation and hair loss. Separately, about 1 in 5 had regrowth in eyebrow hair and 1 in 4 had regrowth in eyelash hair. In the group that took 2 mg of baricitinib, 22.6 percent of participants reached the 80 percent threshold of hair growth. Separately, more than 40 percent of study participants had full regrowth in eyebrow and eyelash hair or regrowth with minimal gaps. “Many patients are pleased when they have above 50 to 60 percent of hair coverage,” she says. Lo Sico notes that 80 and 90 percent hair regrowth is a high bar that is set by the U.S. Reaching 80 percent scalp hair coverage is a dramatic improvement: At that point, the disease is no longer visible, says Mallbris.Īfter a year, nearly 3 in 4 of those people achieved 90 percent scalp hair coverage. 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. In a pooled analysis of the two trials, patients had a mere 14.5 percent scalp hair coverage at the start of the study. 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. 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. 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. Results from two phase 3 trials on baricitinib were published in The New England Journal of Medicine on May 5, 2022. Nearly 2 in 5 Study Participants Had Significant Hair Regrowth 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. “This approval is huge, both for people with alopecia areata and the clinicians who have been advocating for them. “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.īefore 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. “People with alopecia areata face significant challenges, as the disease can be very stigmatizing,” Dr. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”įrustrated 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. “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. People with severe alopecia areata may also lose eyebrows and eyelashes. 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.Īlopecia areata affects more than 300,000 people in the United States each year, often leading to bald patches on the scalp. 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.
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