The disease can vary in severity, but for some, it can be life-altering — a total loss of body hair, including eyelashes and eyebrows, even nose hair and hair in the ears. And, until recently, for those with alopecia areata, there was no treatment to make the hair grow back.
But on Monday, the Food and Drug Administration approved baricitinib, a drug made by Eli Lilly that regrows hair by blocking the immune system from attacking hair follicles. Two other companies, Pfizer and Concert Pharmaceuticals, are close behind with similar drugs, known as JAK inhibitors. The drugs are already on the market for the treatment of rheumatoid arthritis and other autoimmune diseases. F.D.A. approval is important for insurance coverage of these expensive drugs, which have a list price of nearly $2,500 a month.
The Lilly drug was studied in two trials, sponsored by the company and published last month in the New England Journal of Medicine, involving 1,200 patients with severe alopecia areata. Nearly 40 per cent who took the drug had complete or near-complete hair regrowth after 36 weeks. After a year, nearly half of the patients had their hair back.
Dr Brett King, a dermatology professor at Yale University, was the principal investigator for the two Lilly trials and is also leading trials sponsored by the other companies. He said he was optimistic that the success rate for the drugs would get better. Manufacturers may be able to improve the JAK inhibitors for alopecia areata. And when all three companies have drugs on the market, patients who do not respond to one company’s drug might respond to one of the others.
Patients in the Lilly study experienced relatively mild side effects, including a small increased risk of acne, urinary tract infections and other infections. Those side effects were easily treatable or improved without treatment.
The Lilly trial results “are impressive,” wrote Dr Andrew Messenger of the University of Sheffield and Matthew Harries of the University of Manchester in an accompanying editorial. They added that the findings “represent the first published phase 3 trials of any treatment for this condition.”
More than 300,000 Americans live with severe alopecia areata, according to the F.D.A. The impact of the disease is hard to overstate, Dr King said.
For most people with alopecia areata, the disease manifests as one or a few small bald patches on the head. But those with severe cases have something much worse. They may notice small bald spots on their heads one day. Three months or even three weeks later, they have no hair on their bodies.
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