New findings from an additional 16 weeks of follow-up are also showing that continued treatment leads to additional improvement, a lead author of the BRAVE-AA1 and BRAVE-AA2 studies reported at the weekend meeting of the American Academy of Dermatology.
The patients began the study with enough hair loss to score a 50 or higher on a 100-point scale where zero meant no scalp hair loss and 100 was complete baldness.
After 36 weeks of oral therapy, a score of 20 or lower was achieved in 38.8% of patients on the 4 mg dose of baricitinib, 22.8% on the 2 mg dose, and 6.2% among patients given placebo in the larger phase 3 double-blind trial.
In the smaller trial of 546 patients, the respective rates were 35.9%, 19.4% and 3.3%.
In both tests, P<0.001 for each dose, according to the results formally published online Saturday by the New England Journal of Medicine.
The two trials are ongoing and lead author Dr. Brett King of the Yale School of Medicine, in New Haven, Connecticut, told Reuters Health in a telephone interview that at the 52-week mark, the success rate has reached 39.0% for higher-dose patients and 22.6% among recipients of the lower dose. Placebo patients have been switched into the active treatment group.
There is no approved treatment for the chronic autoimmune disorder, but three JAK inhibitors, including baricitinib, are in the process of being tested.
"It's truly life-changing to suffer from alopecia areata, and it is transformation when you can reverse it," Dr. King said.
More than half the patients in the study had very severe disease, reflected by a score of over 95 on the 100-point scale.
The good news from the two studies is the consistency of the results, said Dr. King. Depending on the dose, the drug is "achieving really dramatic hair regrowth in a third or more of patients over 36 weeks."
As the study continues, "future data cuts will show if 40% at week 52 is the plateau, or if 40% turns into 45%," he said.
Whether discontinuation of the drug will cause hair loss to resume is unknown. In a smaller phase 2 study of a different JAK inhibitor, he explained, "with withdrawal of the drug, patients had a relapse of disease over 12 to 24 weeks."
All JAK inhibitors come with a black box warning raising concerns about cancer, infection, and blood clots, but the BRAVE-AA studies have not seen such problems, said Dr. King, an associate professor of dermatology at Yale.
"It tells you there's nothing alarming, at least not on this time scale," he said. "At this moment in time, nothing jumps out."
Acne rates were elevated among baricitinib recipients. It was seen in 5.7% of the volunteers getting 4 mg, 5.5% getting 2 mg and 0.5% of placebo recipients involved in the larger BRAVE-AA1 study. In the smaller BRAVE-AA2 test, the respective rates were 4.7%, 5.8% and 1.9%.
Drug patients were also more prone to urinary tract infections.
"Increases in the LDL cholesterol level were observed in approximately one quarter of the patients who received baricitinib, and increases in the HDL cholesterol level were observed in approximately 40% of patients who received baricitinib," the researchers reported.
The results were collected from 169 centers in 10 countries.
Lilly sells baricitinib under the brand name Olumiant.
The treatment, if approved, is expected to be expensive but Dr. King said most patients would be willing to spend the money because "it is an often-devastating disease for patients and for their loved ones."
When the condition causes a loss of all hair including eyebrows and eyelashes, or leaves irregular patches of hair, "you don't recognize yourself, other people don't recognize you, and other people who look at you think you're dying," he said. "It truly means the world for people to get better."
SOURCE: https://bit.ly/3uuoS7l The New England Journal of Medicine, online March 26, 2022.
By Gene Emery
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