Trial reportAdvances in therapy2024
Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis.
Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03346434 (A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis
Who cites it
15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Comparative efficacy of pediatric atopic dermatitis treatments: a network meta-analysis highlighting dupilumab and pimecrolimus for SCORAD and EASI improvement.Frontiers in immunology · 2026Pooled it
- Emerging treatments for dermatologic diseases in infants, children, and adolescents: a systematic review of clinical trials on biologics and small molecule inhibitors.Inflammopharmacology · 2025Pooled it
- Effects of dupilumab on quality of life in patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2025Pooled it
- Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis.Paediatric drugs · 2026Trial
- Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis.Advances in therapy · 2026Trial
- Pharmacovigilance signals of dupilumab among pediatric patients: A real‑world analysis based on the FAERS database.Human vaccines & immunotherapeutics · 2026Article
- Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Review
- Association betweenFrontiers in medicine · 2026Article
- Development of a clinical indicator-based severity scoring system for pediatric atopic dermatitis and evaluation of dupilumab treatment outcomes.American journal of translational research · 2026Article
- The potential of targeted IL-4 therapy for the comorbidity of atopic dermatitis and attention-deficit/hyperactivity disorder in children via the skin-brain axis.Frontiers in allergy · 2026Article
- Pediatric Atopic Dermatitis Exhibits Distinctive Patterns in JAK/STAT Pathway Activation and CD6-ALCAM Signaling.Immune network · 2025Article
- Targeting the IL-4/IL-4R Axis in Th2 Inflammatory Diseases: A Review of Clinical Efficacy and Safety.Journal of inflammation research · 2025Review
- Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China.Frontiers in immunology · 2025Article
- Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study.Frontiers in pediatrics · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
11 authors at 9 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTreatment 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.
methodsThis 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.
resultsThe 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.
conclusionDupilumab significantly improved AD signs, symptoms and quality of life in children aged 6 months to 5 years with severe AD with acceptable safety.
trial registrationThe trial was registered with ClinicalTrials.gov with ID number NCT03346434, part B.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.