The results of two phase 3 trials of patients with severe alopecia areata (AA) indicate that oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks.
A summary of the two randomized, placebo-controlled trials at 36-weeks (BRAVE-AA1 [654 patients] and BRAVE-AA2 [546 patients]) was first presented at the European Academy of Dermatology and Venereology (EADV) 2021 sessions and published last week in the New England Journal of Medicine. Study results showed nearly 40% of adults with AA who were taking the oral Janus kinase (JAK) 1 and 2 inhibitor saw significant hair regrowth over 52 weeks.
Patients included in the study had a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). They were randomly assigned in a 3:2:2 ratio to receive once-daily baricitinib at a dose of 4 mg, 2 mg, or placebo. The primary endpoint was a SALT score of 20 or less (80% scalp hair coverage) at week 36.
The authors reported the estimated percentage of patients with a SALT score of 20 or less at week 36 in BRAVE-AA1 was 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo, and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2.
In an updated report presented at the annual scientific sessions of the American Academy of Dermatology in Boston, 52-week results from pooled data from both trials revealed that 39% of patients who received 4 mg baricitinib showed at least 80% scalp coverage. A total of 74.1% of that group had at least 90% scalp coverage, or a SALT score ≤10.
In patients who received 2 mg baricitinib, 22.6% had a SALT score ≤20 at 52 weeks, and 67.5% of that group had at least 90% scalp hair coverage at 52 weeks. (In the 52-week evaluation, the investigators noted that the placebo group had been concluded at 36 weeks, and these placebo patients were randomly assigned to either the 4 mg or 2 mg baricitinib groups.)
Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo.
The study authors wrote that longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata.