BACKGROUND AND PURPOSE:

• There are few treatment options for alopecia areata, an autoimmune condition that results in rapid hair loss in the scalp, eyebrows, and eyelashes
• Baricitinib is a selective, reversible inhibitor of Janus kinases 1 and 2, and it may interrupt cytokine signaling thought to be involved in the pathogenesis of alopecia areata
• King et al. (NEJM, 2022) performed two phase 3 randomized trials to assess the efficacy of baricitinib for treating alopecia areata

METHODS:

• Two randomized, placebo-controlled, phase 3 trials
  • BRAVE-AA1 and BRAVE-AA2
• Participants
  • Adults with alopecia areata
  • Severity of Alopecia Tool (SALT) score of ≥50
    • SALT range: 0 (no scalp hair loss) to 100 (complete scalp hair loss)
• Intervention
  • Once-daily baricitinib at a dose of 4 mg
  • Once-daily baricitinib at a dose of 2 mg
  • Placebo
• Study design
  • Participants were randomly assigned to an intervention group in a 3:2:2 ratio
  • Study period: 36 weeks
  • Patients and investigators were blinded to trial-group assignments
• Power analysis
  • 90% Power | two-sided 5% significance level
  • Planned sample size: 625 for BRAVE-AA1 and 476 for BRAVE-AA2 | Additional enrollment to account for drop out and missing data due to  COVID-19
• Primary outcome
  • A SALT score of ≤20 or at week 36

RESULTS:

• BRAVE-AA1: 653 participants | BRAVE-AA2: 546 participants
• Incidence of participants with a SALT score of ≤20 at week 36
  • 4-mg baricitinib
    • BRAVE-AA1: 38.8%
    • BRAVE-AA2: 35.9%
  • 2-mg baricitinib
    • BRAVE-AA1: 22.8%
    • BRAVE-AA2: 19.4%
  • Placebo
    • BRAVE-AA1: 6.2%
    • BRAVE-AA2: 3.3%
• There was a significant difference in the percentage of participants with SALT score of ≤20 between (P<0.001 for each dose vs. placebo)
  • 4-mg baricitinib and placebo
    • BRAVE-AA1: 32.6 percentage points (95% CI, 25.6 to 39.5)
    • BRAVE-AA2: 32.6 percentage points (95% CI, 25.6 to 39.6)
  • 2-mg baricitinib and placebo
    • BRAVE-AA1: 16.6 percentage points (95% CI, 9.5 to 23.8)
    • BRAVE-AA2: 16.1 percentage points (95% CI, 9.1 to 23.2)
• Compared to placebo, baricitinib was associated with increased levels of
  • Acne
  • Elevated levels of creatine kinase
  • Increased levels of low- and high-density lipoprotein cholesterol

CONCLUSION:

• At 36 weeks, patients with severe alopecia areata who received oral baricitinib had more hair regrowth than patients who received placebo
• More trials are needed to assess long term safety and efficacy of baricitinib

Learn More – Primary Sources:

Two Phase 3 Trials of Baricitinib for Alopecia Areata

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