Evidence map›Paper›PMID 35083774›Full record

ArticlePediatric dermatology2022

Infections in children and adolescents treated with dupilumab in pediatric clinical trials for atopic dermatitis-A pooled analysis of trial data.

Amy S Paller, Lisa A Beck, Andrew Blauvelt, Elaine C Siegfried, Michael J Cork, Andreas Wollenberg, Zhen Chen, Faisal A Khokhar, Jignesh Vakil, Annie Zhang and 2 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Pediatric dermatology, 2022. 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 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT03054428 phase3completednot on this map

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

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2017 to 2018Enrolled251ConditionsModerate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic, Eczema, Skin Diseases, Skin, Diseases Genetic, GeneticArmsDupilumab, Placebo
NCT03345914 phase3completednot on this map

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

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2017 to 2019Enrolled367ConditionsDermatitis, AtopicArmsDupilumab, Matching Placebo, Background Treatment: Topical Corticosteroids, Background Treatment: Moisturizers
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Dupilumab for the treatment of eczema molluscatum: A pediatric case report and systematic literature review.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026
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  6. Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026
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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

12 authors at 8 institutions in 3 countries.

Amy S PallerDepartments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Lisa A BeckUniversity of Rochester Medical Center, Rochester, New York, USA.
Andrew BlauveltOregon Medical Research Center, Portland, Oregon, USA.
Elaine C SiegfriedDepartments of Pediatrics and Dermatology, Saint Louis University School of Medicine, St. Louis, Missouri, USA.ORCID https://orcid.org/0000-0002-4794-9905
Michael J CorkSheffield Dermatology Research, University of Sheffield, Sheffield, UK.
Andreas WollenbergDepartment of Dermatology and Allergy, University Hospital, Ludwig-Maximilian University, Munich, Germany.
Zhen ChenRegeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
Faisal A KhokharRegeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
Jignesh VakilSanofi-Genzyme, Cambridge, Massachusetts, USA.
Annie ZhangSanofi-Genzyme, Cambridge, Massachusetts, USA.
Ashish BansalRegeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
Sonya L CyrRegeneron Pharmaceuticals Inc, Tarrytown, New York, USA.ORCID https://orcid.org/0000-0002-7231-0054
Regeneron (United States) · USAVEO Oncology (United States) · USLudwig-Maximilians-Universität München · DENorthwestern University · USOregon Medical Research Center · USSaint Louis University · USUniversity of Rochester Medical Center · USUniversity of Sheffield · GB

Funding

Biomarker Identification, Viral Susceptibility and Management in S. aureus Colonized AD PatientsU01AI152011 · NIAID · UNIVERSITY OF ROCHESTER · PI Lisa Ann Beck · 2020 to 2026
$3.2M
NIAID NIH HHS U01 AI152011Regeneron Pharmaceuticals, Inc.Sanofi
6 · The paper itself

Abstract

BACKGROUND/

objectivePatients with moderate-to-severe atopic dermatitis (AD) have increased risk of cutaneous and extracutaneous infections. Dupilumab has previously been associated with reduced risk of serious/severe infections and non-herpetic skin infections in adults with moderate-to-severe AD. This analysis assessed infection rates with dupilumab versus placebo in pediatric patients with moderate-to-severe and severe AD participating in clinical trials.

methodsThis is a pooled analysis from two 16-week, randomized, placebo-controlled, phase 3 clinical trials of dupilumab: monotherapy in adolescents aged 12-17 years with moderate-to-severe AD (LIBERTY AD ADOL, NCT03054428) and with concomitant topical corticosteroids in children aged 6-11 years with severe AD (LIBERTY AD PEDS, NCT03345914). Data were pooled according to treatment received: placebo/approved dupilumab doses/other studied dupilumab doses/all dupilumab doses. Exposure-adjusted rates (patients with ≥1 event per 100 patient-years [nP/100 PY]) were used to compare treatment groups.

resultsOverall, 612 patients were included: 205 received placebo and 407 received dupilumab (261 received approved dupilumab doses and 146 received other studied dupilumab doses). Overall infection rates were numerically lower with dupilumab versus placebo (nP/100 PY: placebo, 227; approved dupilumab, 173; other dupilumab, 206; all dupilumab, 184). Total skin infections were numerically less frequent in all dupilumab-treated groups versus placebo (nP/100 PY: placebo, 67; approved dupilumab, 30; other dupilumab, 46; all dupilumab, 36).

conclusionsThese data suggest that dupilumab treatment in children and adolescents with AD does not increase infection risk overall and is associated with lower rates of skin infections compared with placebo.

Indexed as

Dermatitis, AtopicSkin Diseases, InfectiousAdolescentAdultAntibodies, Monoclonal, HumanizedChildDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumabatopic dermatitisdupilumabherpetic skin infectionsIL-13IL-4skin infectionssystemic infections

Identifiers

PMID35083774
PMCPMC9302614
OpenAlexW4210339708

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.