Evidence map›Paper›PMID 40728026›Full record

Trial reportPediatric pulmonology2025

Dupilumab Plus Medium-Dose Inhaled Corticosteroid (ICS) Improves Outcomes Compared With Placebo Plus Continued High-Dose ICS in Children With Uncontrolled Moderate-to-Severe Type 2 Asthma.

Leonard B Bacharier, Jorge F Maspero, Nikolaos G Papadopoulos, Rémi Gagnon, Theresa W Guilbert, Changming Xia, Olivier Ledanois, Mena Soliman

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric pulmonology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02948959 (A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT02948959 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma

TypeinterventionalSponsorSanofiRan2017 to 2020Enrolled408ConditionsAsthmaArmsDupilumab, Placebo, Asthma Controller Therapies, Asthma Reliever Therapies
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

8 authors.

Leonard B BacharierMonroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID https://orcid.org/0000-0003-0432-2704
Jorge F MasperoFundación CIDEA, Buenos Aires, Argentina.
Nikolaos G PapadopoulosAllergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
Rémi GagnonClinique Spécialisée en Allergie de la Capitale, Quebec City, Quebec, Canada.
Theresa W GuilbertCincinnati Children's Hospital and University of Cincinnati, Cincinnati, Ohio, USA.
Changming XiaRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Olivier LedanoisSanofi, Paris, France.
Mena SolimanRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.

Funding

This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials. gov Identifier: NCT02948959.
6 · The paper itself

Abstract

backgroundDupilumab improved clinical outcomes in children (aged 6-11 years) with moderate-to-severe asthma and type 2 inflammation (baseline blood eosinophil count ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) in the phase 3 VOYAGE study (NCT02948959). We evaluated dupilumab plus medium-dose ICS versus placebo plus continued high-dose ICS in children in VOYAGE.

methodsChildren were randomized to dupilumab 100/200 mg by body weight or placebo every 2 weeks for 52 weeks. Annualized severe exacerbation rates, change from baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 s (ppFEV

resultsData from 184 children were analyzed (dupilumab plus medium-dose ICS, n = 134; placebo plus high-dose ICS, n = 50). At Week 52, dupilumab plus medium-dose ICS versus placebo plus high-dose ICS significantly reduced exacerbations by 74.3%, and significantly improved ppFEV

conclusionIn children with moderate-to-severe asthma and type 2 inflammation, treatment with dupilumab plus medium-dose ICS reduced exacerbations and improved lung function and asthma control compared with placebo plus continued high-dose ICS.

Indexed as

Adrenal Cortex HormonesAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedAsthmaAdministration, InhalationChildDouble-Blind MethodDrug Therapy, CombinationEosinophilsFemaleForced Expiratory VolumeHumansImmunoglobulin EMaleSeverity of Illness IndexTreatment OutcomeAdrenal Cortex HormonesAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizeddupilumabImmunoglobulin Easthma controldupilumabexacerbationsICS doselung functionpediatric asthma

Identifiers

PMID40728026
PMCPMC12305753

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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.