Understanding Eyebrow and Eyelash Involvement in Patients with Alopecia Areata and Responsiveness to Treatment with Baricitinib.

BACKGROUND

Eyebrow and eyelash (EB/EL) involvement is an important consideration in the assessment of alopecia areata (AA) severity.

OBJECTIVES

We report integrated results from BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) characterising EB/EL involvement at baseline in patients with AA and response to baricitinib treatment.

METHODS

BRAVE-AA1 and BRAVE-AA2 were randomised, double-blind, placebo-controlled trials conducted at 169 centres in 10 countries. Patients were randomised to placebo, baricitinib 2 mg, or baricitinib 4 mg. Pooled data from patients continually treated with baricitinib through Week 52 were included. Outcomes were assessed using the Clinician-Reported Outcome (ClinRO) measure for EB/EL and Severity of Alopecia Tool (SALT) score for scalp.

RESULTS

At baseline, patients with more severe EB/EL involvement had more severe scalp hair loss, with mean SALT scores ranging from 70.6 to 96.0 for patients with no gaps to complete absence of hair, respectively, at EB/EL sites. EB/EL response rates [ClinRO (0,1) with ≥1-point improvement] at Week 36 were significantly higher in patients treated with both baricitinib 2 mg (28.2%, odds ratio [OR]=3.27, 25.1% OR=2.95) and baricitinib 4 mg (44.3% OR=6.84, 46.4% OR=8.21) as compared with placebo (12.6%, 12.4%). There was high concordance between EB response and EL response, with approximately 80% of patients who achieved hair regrowth at one site, achieving regrowth at the other with baricitinib 4 mg. Among scalp responders (SALT score <20 at Week 52), 78.5% and 82.6% achieved an EB and EL response, respectively, and 71.1% of patients achieved a response in both EB and EL with baricitinib 4 mg. Among scalp nonresponders (SALT score >20 at Week 52), 46.7% and 48.7% achieved EB and EL responses, respectively, and 35.4% achieved responses in both EB and EL. Similar trends but lower response rates were observed with baricitinib 2 mg.

CONCLUSIONS

Baseline severity of EB/EL involvement parallels that of the scalp. Baricitinib was efficacious in achieving holistic response across all three hair-bearing sites in a majority of Week 52 scalp responders. These data detail the benefits of baricitinib across important hair-bearing sites involved in AA and highlight that individual patient treatment success should account for the totality of the clinical presentation.

TRIAL REGISTRATION NUMBER

BRAVE-AA1, ClinicalTrials.gov number, NCT03570749, start date, September 24, 2018; BRAVE-AA2, ClinicalTrials.gov number, NCT03899259, start date, July 8, 2019.