in the phase 2/3 BRAVE-AA1 randomized trial, Brett King, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
The results with the 4-mg/day dose of the Janus kinase (JAK) 1 and -2 inhibitor were even more impressive. However, this higher dose, while approved in Europe and elsewhere for the treatment of rheumatoid arthritis, was rejected by the Food and Drug Administration because of safety concerns and is not available in the United States. The 2-mg dose of baricitinib is approved for RA in the United States.
There are currently no FDA-approved treatments for alopecia areata, noted Dr. King, a dermatologist at Yale University, New Haven, Conn.
He reported on 110 adults with severe alopecia areata as defined by a baseline Severity of Alopecia Tool (SALT) score of 87, meaning they averaged 87% scalp hair loss. They averaged a 16-year history of the autoimmune disease. The duration of the current episode was at least 4 years in more than one-third of participants. Clinicians rated more than three-quarters of patients as having no eyebrow or eyelash hair, or significant gaps and uneven distribution.
The primary outcome in this interim analysis was achievement of a SALT score of 20 or less at week 36, meaning hair loss had shrunk to 20% or less of the scalp. Fifty-two percent of patients on baricitinib 4 mg achieved this outcome, as did 33% of those randomized to baricitinib 2 mg and 4% of placebo-treated controls.
In addition, 60% of patients on the higher dose of the JAK inhibitor and 40% on the lower dose rated themselves as having either full eyebrows and eyelashes on both eyes at 36 weeks, or only minimal gaps with even distribution. None of the controls reported comparable improvement, Dr. King said at the conference, which was sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
There were no serious adverse events in this relatively small study. Six cases of herpes simplex and two of herpes zoster occurred in baricitinib-treated patients; there were none in controls.
Session moderator Andrea L. Zaenglein, MD, professor of dermatology and pediatric dermatology at Penn State University, Hershey, said that she was very impressed that baricitinib could achieve substantial hair regrowth in patients with a median duration of hair loss of about 16 years.
“It’s very interesting,” agreed comoderator Ashfaq A. Marghoob, MD, director of clinical dermatology at Memorial Sloan Kettering Cancer Center in Hauppauge, N.Y. “Having this kind of hair regrowth goes against what we learned in our residency, that the longer you’ve gone with hair loss, the less likely it is to ever come back.”
Separately, Eli Lilly issued a press release announcing that both the 2- and 4-mg doses of baricitinib had met the primary endpoint in the phase 3 BRAVE-AA2 trial, showing significantly greater hair regrowth compared with placebo in the 546-patient study. However, the company provided no data, instead stating that the full results will be presented at an upcoming medical conference.