Evidence map›Paper›PMID 39470878›Full record

Trial reportAdvances in therapy2024

Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities.

Mark Boguniewicz, Lawrence D Sher, Amy S Paller, Peter D Arkwright, Shigemi Yoshihara, Zhen Chen, Parul Shah, Ainara Rodríguez Marco

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

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. 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 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT03346434 phase2 / phase3completednot on this map

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

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2017 to 2021Enrolled202ConditionsDermatitis, AtopicArmsDupilumab, Matching placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Biomarkers for therapeutic response and adverse outcomes in atopic dermatitis: A systematic review.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Pooled it
  2. Review
  3. Article
  4. Review
  5. Update on HDM Allergy: Principal Changes over the Years.International journal of molecular sciences · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Mark BoguniewiczUniversity of Colorado School of Medicine, Aurora, CO, USA. boguniewiczm@njhealth.org.ORCID 0000-0002-1015-4439
Lawrence D SherPeninsula Research Associates, Rolling Hills Estates, CA, USA.
Amy S PallerDepartments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Peter D ArkwrightLydia Becker Institute of Immunology & Inflammation, University of Manchester, Manchester, UK.
Shigemi YoshiharaDepartment of Pediatrics, School of Medicine, Dokkyo Medical University, Tochigi, Japan.
Zhen ChenRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Parul ShahRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Ainara Rodríguez MarcoSanofi, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with atopic dermatitis (AD) often have other comorbid type 2 inflammatory conditions. The aim of this study was to evaluate the impact of type 2 comorbidities on the response to and safety of dupilumab in young children with AD.

methodsLIBERTY AD PRESCHOOL part B was a randomized, placebo-controlled trial in children aged 6 months to 5 years with moderate-to-severe AD. In this post hoc analysis, patients were stratified by the presence or absence of caregiver-reported selected type 2 comorbidities at baseline: asthma, allergic rhinitis (AR), and food allergies (FAs).

resultsAt week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and AR, achieved an Investigator's Global Assessment (IGA) score of 0/1 and a ≥ 75% improvement in Eczema Area and Severity Index (all p < 0.05). Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). Numerically more patients receiving dupilumab versus placebo with asthma and significantly more patients without asthma achieved a ≥ 4-point reduction in the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) (p = 0.6 and p < 0.0001). Additionally, significantly more patients receiving dupilumab versus placebo with or without AR (p = 0.008 and p < 0.0001) and with or without FAs (p = 0.0002 and p = 0.004) achieved a ≥ 4-point reduction in the weekly average of daily score on the WSI-NRS. Overall safety was consistent with the known dupilumab safety profile.

conclusionsDupilumab treatment improves AD signs and symptoms in children aged 6 months to 5 years with and without type 2 comorbidities such as asthma, AR, and FAs.

trial registrationClinicalTrials.gov registration number NCT03346434. INFOGRAPHIC: Do type 2 comorbidities impact the response to dupilumab in children with atopic dermatitis? (MP4 103,451 KB).

Indexed as

Antibodies, Monoclonal, HumanizedAsthmaDermatitis, AtopicChild, PreschoolComorbidityDouble-Blind MethodFemaleFood HypersensitivityHumansInfantMaleRhinitis, AllergicSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizeddupilumabAtopic dermatitisComorbiditiesDupilumabPediatricsType 2 inflammation

Identifiers

PMID39470878
PMCPMC11550244

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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.