Related Experiment Video
Updated: Jan 7, 2026
Resolving Water, Proteins, and Lipids from In Vivo Confocal Raman Spectra of Stratum Corneum through a Chemometric Approach
Published on: September 26, 2019
Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis
Audrey Lasek1, Nathalia Bellon2, Stéphanie Mallet3
1Dermatology Department, Saint Vincent de Paul Hospital, Lille, France.
Insights
Dupilumab effectively treated severe atopic dermatitis (AD) in young children. The study confirmed dupilumab
Area of Science:
- Immunology
- Dermatology
- Pediatrics
Background:
- Dupilumab, an anti-interleukin-4/13 antibody, is approved for severe atopic dermatitis (AD) in children aged 6 months to 5 years.
- A French Early Access Program (EAP) was initiated in October 2022 for pediatric patients with severe AD.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of dupilumab in children aged 6 months to 5 years with severe AD requiring systemic treatment.
- To assess treatment outcomes using validated clinical and quality-of-life measures.
Main Methods:
- Cumulative data from 198 children in the French EAP were analyzed.
- Dupilumab was administered every 4 weeks based on weight (200 mg for 5-15 kg, 300 mg for 15-30 kg).
- Clinical assessments included Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), Pruritus-Numerical Rating Scale (P-NRS), and quality-of-life indices (IDQOL/CDLQI) at baseline and follow-up months 1, 3, and 6.
Main Results:
- At 6 months, 83.7% of 116 evaluated patients achieved an IGA score of 0/1.
- Significant improvements were observed in EASI (50/75/90: 94.4%/75.0%/44.4%), P-NRS (≥4-point improvement: 67.6%), and quality-of-life scores.
- The safety profile was consistent with previously established data for dupilumab.
Conclusions:
- Dupilumab demonstrated significant effectiveness in improving skin clearance, pruritus, and quality of life in young children with severe atopic dermatitis.
- The observed safety and efficacy align with findings from clinical studies in moderate-to-severe pediatric AD populations.
Background:
Dupilumab, a human monoclonal anti-interleukin-4/13 antibody, is approved for treating severe atopic dermatitis (AD) in children aged 6 months-5 years. It received approval for an Early Access Program (EAP) for children by the French Health Authority in October 2022.
Objectives:
This EAP aims to evaluate the effectiveness and safety of dupilumab in children (aged 6 months-5 years) with severe AD requiring systemic treatment.
Methods:
Cumulative data from the French EAP were analysed. Children with severe AD were administered dupilumab 200 and 300 mg (children ≥5 to <15 kg and ≥15 to <30 kg, respectively) every 4 weeks via a pre-filled syringe. The Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) 50/75/90, Pruritus-Numerical Rating Scale (P-NRS), Infants' Dermatitis Quality of Life Index (IDQOL; for children aged <4 years) and Children's Dermatology Life Quality Index (CDLQI; for children aged ≥4 years) scores were assessed at baseline and follow-up months (M) 1, 3 and 6. Safety was evaluated.
Results:
A total of 198 children were enrolled (<2 years old: N = 27 [13.6%]; ≥2 years old: N = 171 [86.4%]). Of the 116 evaluated patients (exposed patients with at least ≥1 follow-up form), 83.7% achieved an IGA score of 0/1, 94.4%/75.0%/44.4% achieved an EASI 50/75/90, respectively, and 67.6% achieved a ≥4-point improvement in the P-NRS scores, at M6. The mean ± SD reduction from treatment initiation to M6 in the IGA, EASI and P-NRS scores was -2.1 ± 1.2, -17.5 ± 11.6 and -4.4 ± 2.8, respectively. The mean ± SD IDQOL and CDLQI scores reduced numerically from treatment initiation to M6 by -6.9 ± 6.6 and -8.8 ± 7.3, respectively. Safety was consistent with the established safety profile of dupilumab.
Conclusions:
The effectiveness and safety profile of dupilumab in children (aged 6 months-5 years) with severe AD were consistent with those reported in children with moderate-to-severe AD in clinical studies.
Related Concept Videos
01:29Drug Dosing: Infants and Children
01:30Skin Cancer
Basal Cell Carcinoma (BCC): BCC is the most common type of skin cancer, accounting for about 80% of cases. It typically develops in...
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:25Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...