Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis

Research output: Contribution to journalResearch articleContributedpeer-review


  • Amy S Paller - , Northwestern University Feinberg School of Medicine (Author)
  • Andreas Pinter - , University Hospital Frankfurt (Author)
  • Lara Wine Lee - , Medical University of South Carolina (Author)
  • Roland Aschoff - , Department of Dermatology (Author)
  • Jacek Zdybski - , Klinika Zdybski Dermedic (Author)
  • Christina Schnopp - , Klinikum Rechts der Isar (MRI TUM) (Author)
  • Amy Praestgaard - , Sanofi-Synthelabo GmbH (Author)
  • Ashish Bansal - , Regeneron Pharmaceuticals, Inc. (Author)
  • Brad Shumel - , Regeneron Pharmaceuticals, Inc. (Author)
  • Randy Prescilla - , Sanofi-Synthelabo GmbH (Author)
  • Mike Bastian - , Sanofi-Synthelabo GmbH (Author)


INTRODUCTION: Treatment options for children younger than 6 years with severe atopic dermatitis (AD) are limited, as systemic immunosuppressants may present safety concerns in this young age group. Dupilumab is the first systemic treatment option approved for infants and young children with severe AD in the European Union. This study reports the efficacy and safety of dupilumab with concomitant low-potency corticosteroids in children aged 6 months to 5 years with severe AD.

METHODS: This was a pre-specified subgroup analysis of data for patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomised, double-blind, placebo-controlled, phase III trial of dupilumab. Patients were randomised to either subcutaneously administered dupilumab (200/300 mg) or matched placebo every 4 weeks, plus low-potency topical corticosteroids for 16 weeks. Co-primary endpoints at week 16 were the proportion of patients with IGA ≤ 1 (clear or almost clear skin) and the proportion of patients with ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI-75). Secondary endpoints at week 16 included mean changes in EASI, pruritus, skin pain, sleep loss and quality of life.

RESULTS: The analysis included 125 patients (63 receiving dupilumab vs. 62 placebo). At week 16, significantly more patients receiving dupilumab vs. placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%; P = 0.0085) and EASI-75 (46.0% vs. 6.6%; P < 0.0001). Significant improvements with dupilumab were observed in all secondary endpoints, including a least squares mean 48.9% reduction in pruritus. The overall incidence of adverse events (AEs) was similar between the dupilumab and placebo groups (66.7% vs. 73.8%). No dupilumab-related AEs were serious or led to treatment discontinuation.

CONCLUSION: Dupilumab significantly improved AD signs, symptoms and quality of life in children aged 6 months to 5 years with severe AD with acceptable safety.

TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov with ID number NCT03346434, part B.


Original languageEnglish
Pages (from-to)1046-1061
Number of pages16
JournalAdvances in therapy
Issue number3
Early online date9 Jan 2024
Publication statusPublished - Mar 2024

External IDs

Scopus 85181691342
Mendeley 624b441c-a1f7-3b98-91f8-000965e12654



  • Adrenal Cortex Hormones/adverse effects, Antibodies, Monoclonal, Humanized, Child, Child, Preschool, Dermatitis, Atopic/drug therapy, Dermatologic Agents/therapeutic use, Double-Blind Method, Eczema, Glucocorticoids/therapeutic use, Humans, Immunoglobulin A/therapeutic use, Injections, Subcutaneous, Pruritus/chemically induced, Quality of Life, Severity of Illness Index, Treatment Outcome, Dermatologic Agents/adverse effects, Infant, Antibodies, Monoclonal, Humanized/adverse effects, Immunoglobulin A, Pruritus/prevention & control