Trial reportAmerican journal of clinical dermatology2024
Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study.
Trial report in American journal of clinical dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
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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.
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis
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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy, Safety, Quality of Life, and Adherence of Dupilumab in Pediatric Atopic Dermatitis: A Systematic Review.Clinical drug investigation · 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
- Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis.Paediatric drugs · 2026Trial
- Safety and Efficacy of Treatment with Dupilumab for up to 2 Years in Infants and Young Children with Atopic Dermatitis.American journal of clinical dermatology · 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
- Low Infection Rates With Long-Term Dupilumab Treatment in Patients Aged 6 Months to 5 Years: An Open-Label Extension Study.Pediatric dermatologyTrial
- Pharmacovigilance signals of dupilumab among pediatric patients: A real‑world analysis based on the FAERS database.Human vaccines & immunotherapeutics · 2026Article
- Healthcare resource utilization and costs in pediatric patients under 6 years old with atopic dermatitis in the United States: A retrospective, observational, cross-sectional study.JAAD international · 2026Article
- Atopic dermatitis management: integrating disease mechanisms with precision medicine and nanotechnology-based targeted therapies.Irish journal of medical science · 2026Review
- Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
- Dupilumab's Real-World Efficacy and Safety Across Age Groups for Children and Adolescents With Paediatric Atopic Dermatitis.The Australasian journal of dermatology · 2026Article
- Rituximab for autoimmune blistering diseases in pregnancy and children: a clinical review.International journal of women's dermatology · 2026Review
- Dupilumab as an effective therapy for eosinophilic esophagitis in pediatric patients weighing less than 15 kilograms.JPGN reports · 2026Article
- Review
- Supporting evidence and recommendations for the management of patients with systemic-eligible atopic dermatitis: A Canadian consensus document.JAAD international · 2026Article
- Diagnosis and Management of Comorbid Autoimmune Disorders in Children with Chronic Spontaneous Urticaria.Journal of inflammation research · 2026Review
- Alopecia Areata and Atopic Dermatitis: Common Mechanisms and Emerging Therapeutics.Journal of inflammation research · 2026Review
- A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.Dermatology and therapy · 2026Article
- Anti-Inflammatory Therapies for Atopic Dermatitis: A New Era in Targeted Treatment.Journal of clinical medicine · 2025Review
- Comparative Efficacy and Safety of Tralokinumab and Dupilumab in Moderate-to-Severe Atopic Dermatitis: A Narrative Review.Journal of clinical medicine · 2025Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPediatric patients with moderate-to-severe atopic dermatitis (AD) often experience a high disease burden and have a high risk of persistent disease. Standard-of-care immunosuppressive systemic treatments have been used off-label for AD in pediatric patients despite concerns for suboptimal safety with continuous use and risk of relapse upon discontinuation. The biologic agent dupilumab is the first systemic treatment approved for moderate-to-severe AD in children as young as 6 months. Long-term safety and efficacy data in this patient population are needed to inform continuous AD management.
objectivesThe purpose of this work was to determine the long-term safety and efficacy of dupilumab treatment up to 1 year in an open-label extension (OLE) study [LIBERTY AD PED-OLE (NCT02612454)] in children aged 6 months to 5 years with moderate-to-severe AD who previously participated in the 16-week, double-blind, phase 3 LIBERTY AD PRESCHOOL trial (NCT03346434 part B; parent study) and were subsequently enrolled in PED-OLE.
methodsIn PED-OLE, patients received dupilumab every 4 weeks according to a weight-tiered regimen (body weight ≥ 5 kg to < 15 kg: 200 mg; ≥ 15 kg to < 30 kg: 300 mg).
resultsData for 142 patients were analyzed, 60 of whom had completed the 52-week visit at time of database lock. Mean age at baseline was 4.1 y [SD, 1.13; range, 1.0-5.9 years]. A majority (78.2%) of patients reported ≥ 1 treatment-emergent adverse event (TEAE), most of which were mild or moderate and transient. The most frequently reported TEAEs were nasopharyngitis (19.7%), cough (15.5%), and pyrexia (14.1%). One TEAE led to treatment discontinuation (severe urticaria, which resolved in 1 day). By week 52, 36.2% of patients had achieved an Investigator's Global Assessment score of 0/1 (clear/almost clear skin), and 96.6%, 79.3%, and 58.6% had at least 50%, 75%, or 90% improvement, respectively, in Eczema Area and Severity Index scores.
conclusionsConsistent with results seen in adults, adolescents, and older children (aged 6-11 years), treatment with dupilumab for up to 1 year in children aged 6 months to 5 years with inadequately controlled moderate-to-severe AD demonstrated an acceptable long-term safety profile and sustained efficacy. These results support the long-term continuous use of dupilumab in this patient population.
trial registrationClinicalTrials.gov Identifiers: NCT02612454 and 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.