Baricitinib is effective in treating early- and late-onset alopecia areata at dosages of both 2 mg and 4 mg, according to research presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
Data from phase 2 of the ongoing, multicenter, randomized, double-blind, placebo-controlled, adaptive phase 2/3 BRAVE-AA1 trial (NCT03570749) were used to analyze baseline characteristics among groups and change in primary outcomes from baseline to week 36 in patients with early and late-onset alopecia areata.
Primary outcomes for this study were percent change from baseline on Severity of Alopecia Tool (SALT) score to week 36 and percentage of patients achieving a SALT score of 20 or less in that same period.
Participants (N=82) were randomly assigned to 1 of 3 groups: placebo (n=28), baricitinib 2 mg (n=27), and baricitinib 4 mg (n=27). Among patients in the placebo group, 15 and 13 patients, respectively, reported early- and late-onset alopecia areata, compared with 10 and 17 patients, respectively, in both the baricitinib 2 mg and 4 mg groups. At baseline, mean SALT score in patients with early-onset AA ranged from 82.8 to 94.1, and in the late-onset AA group, mean SALT scores ranged from 83.7 to 88.0; these scores were comparable.
By 36 weeks, SALT score improvements were seen in both baricitinib groups. Least squares mean percent changes from baseline were -49.7% in the early-onset group and -46.2% in the late-onset group among those treated with baricitinib 2 mg, and -46.5% and -63.8%, respectively, in the early- and late-onset groups among those treated with baricitinib 4 mg. Changes in the placebo group were -14.7% and -6.8% in patients with early- and late-onset alopecia areata, respectively.
“These results support the potential use of baricitinib in the treatment of early- and late-onset AA [alopecia areata] in patients who have greater than 50% hair loss,” the researchers concluded. “A longer duration of treatment and a larger sample size will be required to capture the full extent of the clinical response with both doses in patients with early- and late-onset AA [alopecia areata].”
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Disclosure: This clinical trial was supported by Eli Lilly and Company and Incyte Corporation. Please see the original reference for a full list of authors’ disclosures.
Ko J, Roberts J, Hordinsky M, et al. Response to baricitinib in the treatment of patients with early and late onset alopecia areata in the phase 2 portion of BRAVE-AA1 randomized controlled trial. Presented at: AAD VMX 2021; April 23-25, 2021. Abstract/Poster 27604.