Delgocitinib ointment shows efficacy for atopic dermatitis in phase 3 trial

  • Nakagawa H & al.
  • J Am Acad Dermatol
  • 03/02/2020

  • Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Delgocitinib 0.5% ointment is associated with clinical efficacy and good safety in patients with moderate to severe atopic dermatitis (AD), according to results from a phase 3 trial.

Why this matters

  • Novel topical treatment options with a good efficacy-safety profile are needed for AD.

Key results

  • Delgocitinib was associated with a greater least-squares mean percentage change from baseline compared with vehicle at 4 weeks: −44.3% vs 1.7% (P<.001>
  • Compared with vehicle, delgocitinib was associated with higher rates of patients achieving ≥50% improvement on:
    • Modified Eczema Area and Severity Index (mEASI-50): 51.9% vs 11.5% (P<.001>
    • mEASI-75: 26.4% vs 5.8% (P<.01>
  • 50.6% of patients who received delgocitinib experienced adverse events (44.2% mild, 6.5% moderate).
    • The most common adverse event was nasopharyngitis (19.5%).

Study design

  • 158 patients with moderate to severe AD were randomly assigned to receive delgocitinib 0.5% ointment (n=106) or vehicle (n=52), and followed for efficacy and safety outcomes.
  • Funding: Japan Tobacco Inc.

Limitations

  • Short trial duration.