Evidence map›Paper›PMID 38348724›Full record

Trial reportActa dermato-venereologica2024

Clinically Meaningful Responses to Dupilumab Among Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis who did Not Achieve Clear or Almost Clear Skin According to the Investigator's Global Assessment: A Post Hoc Analysis of a Phase 3 Trial.

Michael J Cork, Benjamin Lockshin, Andreas Pinter, Zhen Chen, Brad Shumel, Randy Prescilla

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Acta dermato-venereologica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
4.3field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  3. Article
  4. Fixed Drug Eruption due to Dupilumab.Acta dermato-venereologica · 2024
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 3 countries.

Michael J CorkSheffield Children's Hospital, Sheffield, UK; Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK. m.j.cork@sheffield.ac.uk.
Benjamin LockshinUS Dermatology Partners, Rockville, MD, USA; Georgetown University, Washington, DC, USA.
Andreas PinterDepartment of Dermatology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany.
Zhen ChenRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Brad ShumelRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Randy PrescillaSanofi, Cambridge, MA, USA.
Regeneron (United States) · USGeorgetown University · USGoethe University Frankfurt · DESanofi (United States) · USUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In young children, atopic dermatitis (AD) imposes a multidimensional burden on many aspects of their quality of life (QoL) and that of their families. LIBERTY AD PRESCHOOL part B was a randomized, double- blinded, placebo-controlled phase 3 trial in 162 children (aged 6 months to 5 years) with moderate-to- severe AD receiving dupilumab or placebo, plus low-potency topical corticosteroids. Post hoc analyses were performed on the full analysis set (FAS) and a subset of patients with Investigator's Global Assessment score > 1 at week 16. The primary outcome was the proportion of patients at week 16 achieving a composite endpoint encompassing clinically meaningful changes in AD signs, symptoms and QoL: ≥ 50% improvement in Eczema Area and Severity Index; and/or ≥ 4-point reduction in worst scratch/itch numerical rating scale; and/or ≥ 6-point reduction in Children's Dermatology Life Quality Index/Infants' Dermatitis Quality of Life Index. Significantly more patients receiving dupilumab vs placebo achieved the composite endpoint in both the FAS (77.7% vs 24.6%, p < 0.0001) and subgroup (68.9% vs 21.5%, p < 0.0001). Dupilumab provided rapid and significant, clinically meaningful improvements in AD signs, symptoms, and QoL in the overall group and subgroup of patients who did not achieve clear or almost clear skin at week 16.

Indexed as

Antibodies, Monoclonal, HumanizedDermatitis, AtopicChildChild, PreschoolDouble-Blind MethodHumansInjections, SubcutaneousQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID38348724
PMCPMC10875623
OpenAlexW4391754341

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.