Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice - Archive ouverte HAL Access content directly
Journal Articles Journal of the European Academy of Dermatology and Venereology Year : 2022

Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice

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A. Lasek
J Mazereeuw‐hautier
C. Chiaverini
T. Hubiche
  • Function : Author
H. Aubert
C. Fievet
  • Function : Author
A. Bellissen
  • Function : Author
A. Nosbaum
  • Function : Author
A. Leymarie
  • Function : Author
P. Armingaud
  • Function : Author
E. Mahé

Abstract

Background: Dupilumab is the first biotherapy available for the treatment of moderate-to-severe childhood atopic dermatitis (AD). Objective: The aim of this study was to evaluate the effectiveness and safety of dupilumab in daily practice. Methods: Patients aged 6-11, who had received a first dose of dupilumab, were included in this multicentre retrospective cohort study. The primary endpoint was change in SCORAD after 3 months of treatment. Secondary endpoints were change in IGA score at 3 months, proportion of patients with SCORAD50 and SCORAD75, description of adverse events and proportion of children in our cohort who would be excluded from pivotal phase 3 clinical trial. Results: Eighty patients were included. After 3 months of treatment, there was a significant decrease in SCORAD (mean: 21.8 ± 13.8 vs 53.9 ± 18.5; P < 0.0001) and IGA (1.3 ± 0.8 vs 3.5 ± 0.7; P < 0.0001). Conjunctivitis was observed in 11.3% (n = 9/80); three patients experienced dupilumab facial redness (DFR); 17.5% (n = 14/80) reported injection site reactions; 6.3% (n = 5/80) discontinued treatment. 61.2% (n = 49/80) children were ineligible in the phase 3 trial. Limitations: There is no control group. Because it was a real life study based on information from patient medical records in a French multicentre cohort, we cannot rule out the presence of reporting bias generated by the use of patient reported characteristics and missing information. Conclusion: These real-life data confirm the efficacy and safety of dupilumab in children with moderate to severe AD extended to dyshidrosis and atopic prurigo, but it also revealed a lower frequency of DFR and conjunctivitis. However, administration in injectable form may be a barrier in this age group.
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Dates and versions

hal-03903398 , version 1 (16-12-2022)

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A. Lasek, N. Bellon, S. Mallet, E. Puzenat, A.C. Bursztejn, et al.. Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice. Journal of the European Academy of Dermatology and Venereology, 2022, 36 (12), pp.2423 - 2429. ⟨10.1111/jdv.18450⟩. ⟨hal-03903398⟩
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