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Clinical Trial
. 2020 Nov;83(5):1282-1293.
doi: 10.1016/j.jaad.2020.06.054. Epub 2020 Jun 20.

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  1 , Elaine C Siegfried  2 , Diamant Thaçi  3 , Andreas Wollenberg  4 , Michael J Cork  5 , Peter D Arkwright  6 , Melinda Gooderham  7 , Lisa A Beck  8 , Mark Boguniewicz  9 , Lawrence Sher  10 , Jamie Weisman  11 , John T O'Malley  12 , Naimish Patel  12 , Megan Hardin  12 , Neil M H Graham  13 , Marcella Ruddy  13 , Xian Sun  13 , John D Davis  13 , Mohamed A Kamal  13 , Faisal A Khokhar  13 , David M Weinreich  13 , George D Yancopoulos  13 , Bethany Beazley  13 , Ashish Bansal  13 , Brad Shumel  14
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Free article
Clinical Trial

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 et al. J Am Acad Dermatol. 2020 Nov.
Free article

Erratum in

  • Correction.
    [No authors listed] [No authors listed] J Am Acad Dermatol. 2021 Jan;84(1):230. doi: 10.1016/j.jaad.2020.10.013. Epub 2020 Oct 15. J Am Acad Dermatol. 2021. PMID: 33172720 No abstract available.

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.

Keywords: atopic dermatitis; children; dupilumab; pediatric; severe.

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