Atopic dermatitis: abrocitinib shows good efficacy and safety in phase 3 RCT

  • Silverberg JI & al.
  • JAMA Dermatol
  • 3 Jun 2020

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

Why this matters

  • These results support findings from JADE MONO-1, an earlier phase 3 trial of abrocitinib.

Key results

  • Abrocitinib was associated with superior efficacy compared with placebo:
    • Investigator’s Global Assessment score 0/1: 38.1% for 200 mg, 28.4% for 100 mg, 9.1% for placebo (P<.001>
    • 75% improvement in Eczema Area and Severity Index score: 61.0% for 200 mg, 44.5% for 100 mg, 10.4% for placebo (P<.001>
    • ≥4-point improvement in Peak Pruritus Numerical Rating Scale: 55.3% for 200 mg, 45.2% for 100 mg, 11.5% for placebo (P≤.001).
  • Adverse events were reported for 65.8% of patients receiving 200 mg abrocitinib, 62.7% of patients receiving 100 mg abrocitinib, and 53.8% of patients receiving placebo.
    • Rates of serious adverse events were 1.3%, 3.2%, and 1.3%, respectively.

Study design

  • Included 391 patients with moderate-to-severe atopic dermatitis, 155 who received 200 mg abrocitinib, 158 who received 100 mg abrocitinib, and 78 who received placebo.
  • Efficacy and safety outcomes were assessed.
  • Funding: Pfizer Inc.

Limitations

  • Short treatment duration and follow-up.