Baricitinib Continuously Improves Hair Regrowth in Severe Alopecia Areata

In severe alopecia areata (AA), the efficacy of baricitinib continuously improves through week 52, according to study results published in the American Journal of Clinical Dermatology.

Researchers sourced data from the BRAVE-AA1 (ClinicalTrials.gov Identifier: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov Identifier: NCT03899259) studies, which are ongoing randomized, double-blind, parallel-group, placebo-controlled trials that started recruiting patients with severe AA in 2019.

In both trials, participants were randomly assigned in a 2:3:2 ratio to receive either oral baricitinib 2 mg, oral baricitinib 4 mg, or placebo daily for 36 weeks, followed by an extension through week 68. In this analysis, the subset of participants who were randomly assigned to receive baricitinib and remained on treatment through week 52 were evaluated for efficacy and safety. The primary efficacy outcome was Severity of Alopecia Tool (SALT) score of 20 or less. Severe AA was defined as a SALT score of at least 50 at baseline that did not improve between 6 months and 8 years.

In BRAVE-AA1, 184 participants received baricitinib 2 mg and 281 participants received baricitinib 4 mg. In BRAVE-AA2, 156 participants received baricitinib 2 mg and 234 participants received baricitinib 4 mg baricitinib. Participants in the 4 groups comprised 58.7% to 66.0% women, they had a mean age of 36.3 to 39.0 years, 43.9% to 61.5% were White, and the average duration of AA was 11.8 to 13.1 years.

The proportion of participants who achieved the primary efficacy outcome increased continuously throughout treatment. By week 52, 21.2% and 24.4% of the low-dose recipients and 40.9% and 36.8% of the high-dose recipients achieved a SALT score of 20 or less, depending on the trial.

Among the subset of participants with very severe disease at baseline (SALT 95-100), 10.3% and 15.1% of the low-dose and 27.7% and 27.7% of the high-dose recipients achieved a SALT score of 20 or less at week 52, depending on the trial.

In addition, among participants with a ClinRO Measure for Eyebrow Hair Loss score of 2 to 3 at baseline, 16.3% to 27.9% of the low-dose recipients and 39.4% to 49.7% of the high-dose recipients had at least a 2-point improvement in their eyebrow hair loss score at week 52.

Treatment-emergent adverse events (TEAEs) occurred among 58.5% to 74.2% of those who received baricitinib 2 mg and 69.6% to 77.3% of those who received baricitinib 4 mg. Most events were either mild (32.2%-38.6%) or moderate (23.5%-34.8%) in severity. Discontinuations due to TEAE occurred among 2.2% of low-dose recipients and 2.9% of high-dose recipients in BRAVE-AA1, and 2.6% of low-dose recipients and 4.3% of high-dose recipients in BRAVE-AA2.

The most common TEAEs were headache (6.0%-12.4%), upper respiratory tract infections (6.6%-11.0%), urinary tract infection (2.7%-10.3%), blood creatine phosphokinase increase (0%-9.3%), nasopharyngitis (3.2%-8.6%), acne (5.6%-7.1%), and COVID-19 infection (1.6%-5.6%).

The major limitation of the study was the lack of a comparator arm.

Study authors conclude, “Safety findings were consistent with the known safety profile of baricitinib. These results confirm the potential for baricitinib in the treatment of severe AA.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.