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Dupilumab Treatment in Children Aged 6-11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
Maddalena Napolitano1, Gabriella Fabbrocini2, Iria Neri3
1Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy. maddy.napolitano@gmail.com.
Insights
Dupilumab effectively treats moderate-to-severe paediatric atopic dermatitis (AD) in children aged 6-11 years. Real-world data show significant improvements in skin severity, itch, sleep, and quality of life with a favorable safety profile.
Area of Science:
- Dermatology
- Paediatric Medicine
- Immunology
Background:
- Paediatric atopic dermatitis (AD) management is challenging, often relying on topical treatments.
- Dupilumab, a monoclonal antibody, is approved for moderate-to-severe AD in children aged 6-11 years unresponsive to topical therapies.
Purpose of the Study:
- To evaluate the real-life effectiveness and safety of dupilumab in treating children aged 6-11 years with moderate-to-severe AD.
Main Methods:
- Retrospective data collection from 24 centers on 55 children (aged 6-11) with moderate-to-severe AD treated with dupilumab.
- Dupilumab administered subcutaneously: 300 mg induction, then 300 mg every 4 weeks.
- Efficacy assessed using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS), Sleep NRS (S-NRS), and Children's Dermatology Life Quality Index (c-DLQI) at baseline and weeks 2, 4, and 16.
Main Results:
- Significant improvements observed in EASI, P-NRS, S-NRS, and c-DLQI from baseline to week 16.
- At week 16, 74.54% of patients achieved EASI75.
- Significant mean percentage reductions at week 16: P-NRS (68.39%), S-NRS (70.22%), and c-DLQI (79.03%).
Conclusions:
- Real-world data support dupilumab's effectiveness in paediatric AD across all disease aspects.
- Dupilumab improved disease severity, symptom intensity, sleep, and quality of life.
- The treatment demonstrated a good safety profile in this paediatric population.
Background:
The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6-11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable.
Objectives:
The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years.
Methods:
Demographic and clinical data of children aged 6-11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children's Dermatology Life Quality Index (c-DLQI) score.
Results:
A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively).
Conclusions:
Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.
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