Dupilumab shows efficacy for atopic dermatitis in adolescents

  • Simpson EL & al.
  • JAMA Dermatol
  • 6 Nov 2019

  • International Clinical Digest
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Takeaway

  • Dupilumab is associated with significant treatment response compared with placebo in adolescents with inadequately controlled moderate-to-severe atopic dermatitis (AD), according to a multicentre, randomised, controlled, phase 3 trial.

Why this matters

  • These phase 3 trial results led to approval of dupilumab in this patient population.

Key results

  • Dupilumab was associated with a significantly higher rate of ≥75% improvement in the Eczema Area and Severity Index (EASI-75) compared with placebo (41.5% for Q2W, 38.1% for Q4W, 8.2% for placebo; P<.001>
  • Dupilumab was associated with a significantly higher rate of Investigator’s Global Assessment 0/1 compared with placebo (24.4% for Q2W, 17.9% for Q4W, 2.4% for placebo; P<.001>
  • Dupilumab was associated with numerically higher rates of conjunctivitis (9.8% for Q2W, 10.8% for Q4W, 4.7% for placebo) and injection-site reactions (8.5% for Q2W, 6.0% for Q4W, 3.5% for placebo) compared with placebo.

Study design

  • 251 adolescent patients with moderate-to-severe AD inadequately controlled with topical medications or for whom topical therapy was inadvisable were included and randomly assigned 1:1:1 to receive dupilumab Q2W, dupilumab Q4W, or placebo.
  • Funding: Sanofi, Regeneron Pharmaceuticals Inc.

Limitations

  • Relatively short treatment time (16 weeks).