Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial

Amy S. Paller, Elaine C. Siegfried, Diamant Thaçi, Andreas Wollenberg, Michael J. Cork, Peter D. Arkwright, Melinda Gooderham, Lisa A. Beck, Mark Boguniewicz, Lawrence Sher, Jamie Weisman, John T. O'Malley, Naimish Patel, Megan Hardin, Neil M.H. Graham, Marcella Ruddy, Xian Sun, John D. Davis, Mohamed A. Kamal, Faisal A. KhokharDavid M. Weinreich, George D. Yancopoulos, Bethany Beazley, Ashish Bansal, Brad Shumel*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Background: Children with severe atopic dermatitis (AD) have limited treatment options. Objective: We report the efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies. Methods: In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight <30 kg; 200 mg q2w, baseline weight ≥30 kg), or placebo; with concomitant medium-potency TCS. Results: Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children <30 kg and 200 mg q2w in children ≥30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo + TCS. Limitations: Short-term 16-week treatment period; severe AD only. Conclusion: Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.

Original languageEnglish (US)
Pages (from-to)1282-1293
Number of pages12
JournalJournal of the American Academy of Dermatology
Volume83
Issue number5
DOIs
StatePublished - Nov 2020

Keywords

  • atopic dermatitis
  • children
  • dupilumab
  • pediatric
  • severe

ASJC Scopus subject areas

  • Dermatology

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