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Grand Rounds

RCT Results: Does Baricitinib Treatment Promote Hair Regrowth for Patients with Severe Alopecia Areata?

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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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