Atopic dermatitis: dupilumab found safe, effective in pooled analysis

  • Thaçi D & al.
  • J Dermatol Sci
  • 12 Mar 2019

  • International Clinical Digest
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Takeaway

  • Pooled analysis of the phase 3 LIBERTY AD SOLO 1 and 2 trials indicates that dupilumab (Dupixent) is associated with clinical improvement of patients with moderate to severe atopic dermatitis (AD).

Why this matters

  • Dupilumab has been approved in the United States; this pooled analysis further explores the efficacy and safety outcomes from the pivotal trials.

Key results

  • Dupilumab was associated with improved clinical severity compared with placebo (≥50% improvement in Eczema Area and Severity Index [EASI-50], EASI-75, EASI-90; P<.0001 for all>
  • Dupilumab was associated with a higher proportion of patients achieving an Investigator’s Global Assessment score of 0/1 or a reduction of ≥2 points vs baseline compared with placebo (P<.0001 for all>
  • Dupilumab was associated with significant improvement in quality of life (Dermatology Life Quality Index) and anxiety/depression (Hospital Anxiety and Depression Scale; P<.0001 all>
  • Placebo and dupilumab were associated with a similar incidence of adverse events (68.6% vs 69.0%).

Study design

  • The LIBERTY AD SOLO 1 and 2 trials (identical design) included 1379 adults with moderate to severe disease randomly assigned to receive dupilumab 300 mg once weekly (N=462), dupilumab 300 mg every 2 weeks (N=457), or placebo (N=460) over the course of 16 weeks.
  • Funding: Sanofi; Regeneron Pharmaceuticals, Inc.

Limitations

  • Short trial duration.