Trial reportAmerican journal of clinical dermatology2025
The Safety Data of Dupilumab for the Treatment of Moderate‑to‑Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults.
Trial report in American journal of clinical dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 14 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 Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
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 Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe 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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Cutaneous T-cell lymphomas and dupilumab for atopic dermatitis: A systematic review and expert consensus.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Pooled it
- Revolutionizing dermatopathology using AI in skin diagnostics: scoping review.Frontiers in medicine · 2026Pooled it
- Type-2-Inflammatory-Diseases Share Comorbidities, Molecular Signatures, IL4/IL13 Genetics, and Response to IL4/IL13 Blockade.Allergy · 2026Article
- Minimal Disease Activity as A New Therapeutic Target in Atopic Dermatitis: A 5-Year Real-Life Experience With Dupilumab.International journal of dermatology · 2026Article
- From Barrier Disruption and Immune Dysregulation to Targeted Therapies in Atopic Dermatitis.Clinical reviews in allergy & immunology · 2026Review
- A real-world disproportionality analysis of dupilumab safety in children aged 0-5 years with atopic dermatitis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Cutaneous T-cell lymphoma and dupilumab for atopic dermatitis: Practical guidance for a clinical conundrum.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Summary of Research: Dupilumab Safety for Treating Infants to Adults with Moderate-to-Severe Atopic Dermatitis.Advances in therapy · 2026Article
- Prescribing Biologic Immune-Modifying Therapies for Patients with a History of Cancer: A Cross-Specialty Review.Current oncology (Toronto, Ont.) · 2026Review
- Calcineurin Inhibitors in Atopic Dermatitis: Balancing Tradition with Emerging Therapeutics.Medical sciences (Basel, Switzerland) · 2026Review
- Association betweenFrontiers in medicine · 2026Article
- Efficacy and safety of dupilumab in moderate-to-severe atopic dermatitis with stage 3-5 chronic kidney disease: a retrospective real-world study.Frontiers in medicine · 2026Article
- Hypereosinophilia With Organ Damage Secondary to Dupilumab Therapy: A Case Report and Literature Review.Case reports in dermatological medicine · 2026Article
- Safety of Dupilumab and Risk of Cutaneous T-Cell Lymphoma in Pediatric Patients With Atopic Dermatitis: A Data-Driven Guide to Counseling Patients and Families.Pediatric dermatologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAtopic dermatitis (AD) significantly affects quality of life in patients of all ages and requires long-term treatment. Dupilumab is approved for uncontrolled moderate-to-severe AD in patients aged ≥ 6 months and in other type 2 inflammatory diseases. Data from placebo-controlled, randomized clinical trials (RCTs) and long-term open-label extensions (OLEs) enable comprehensive assessment of dupilumab's safety profile for up to 5 years.
objectiveTo integrate short- and long-term dupilumab safety data in patients with moderate-to-severe AD.
methodsWe describe safety from eight phase 3 trials with > 7000 patient-years of dupilumab use: five 16-week RCTs in children (6 months-11 years, with concomitant topical corticosteroids [TCS]) and adolescents and adults (≥ 12 years, without TCS); one 52-week RCT in adults (with TCS); and two OLEs in children and adolescents (6-11- and 12-18-year cohorts, ± TCS, duration ≤ 1 year) and adults (± TCS, duration ≤ 5 years).
resultsThe proportion of patients experiencing ≥ 1 treatment-emergent adverse event (TEAE) in RCTs was lower with dupilumab versus placebo in children/infants and was similar with dupilumab versus placebo in adults/adolescents. Exposure-adjusted incidence rates with longer-term treatment in OLEs were similar to the RCTs. Most TEAEs reported in RCT and OLE studies were mild to moderate and not related to study drug (per investigators). Fewer patients in the dupilumab versus placebo treatment arms experienced serious TEAEs (16-week RCTs: infants/children 0.8% vs 3.0%; adults/adolescents 2.0-2.2% vs 4.6%; 52-week RCT: 3.2-3.6% vs 5.1%). Common TEAEs that had higher incidence rates with dupilumab compared with placebo in RCTs included injection-site reactions (Medical Dictionary for Regulatory Activities High Level Term) and conjunctivitis (clustered term). Serious infections and non-herpetic skin infections were more frequent with placebo.
conclusionsIn the most comprehensive dupilumab safety assessment to date, safety was consistent with the known dupilumab safety profile. [Graphical abstract and video abstract available.]
trial registrationClinicalTrials.gov Identifiers: NCT03346434; NCT03345914; NCT03054428; NCT02277743; NCT02277769; NCT02260986; NCT01949311; NCT02612454. EudraCT: 2016-000955-28; 2016-004997-16; 2015-004458-16; 2014-001198-15; 2014-002619-40; 2013-003254-24; 2013-001449-15; 2015-001396-40. The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children,Adolescents, and Adults(MP4 64,891 KB).
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Registered trials
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.