Evidence map›Paper›PMID 37300760›Full record

Trial reportAmerican journal of clinical dermatology2023

Dupilumab Provides Clinically Meaningful Responses in Children Aged 6-11 Years with Severe Atopic Dermatitis: Post Hoc Analysis Results from a Phase III Trial.

Elaine C Siegfried, Michael J Cork, Norito Katoh, Haixin Zhang, Chien-Chia Chuang, Ryan B Thomas, Ana B Rossi, Sonya L Cyr, Annie Zhang

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase IIIVideo-Audio Media
In one paragraph

Trial report in American journal of clinical dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345914 (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), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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.

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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
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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

9 authors at 5 institutions in 4 countries.

Elaine C SiegfriedSaint Louis University, St. Louis, MO, USA.
Michael J CorkSheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield Children's Hospital, Sheffield, UK.
Norito KatohDepartment of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.
Haixin ZhangRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Chien-Chia ChuangSanofi, Cambridge, MA, USA.
Ryan B ThomasRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Ana B RossiSanofi, Cambridge, MA, USA.
Sonya L CyrRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Annie ZhangSanofi, Cambridge, MA, USA. annie.zhang@sanofi.com.
Regeneron (United States) · USSanofi (United States) · USKyoto Prefectural University of Medicine · JPSaint Louis University · USUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren with severe atopic dermatitis (AD) have a multidimensional disease burden.

objectiveHere we assess the clinically meaningful improvements in AD signs, symptoms, and quality of life (QoL) in children aged 6-11 years with severe AD treated with dupilumab compared with placebo.

methodsR668-AD-1652 LIBERTY AD PEDS was a randomized, double-blinded, placebo-controlled, parallel-group, phase III clinical trial of dupilumab with concomitant topical corticosteroids (TCS) in children aged 6-11 years with severe AD. This post hoc analysis focuses on 304 patients receiving either dupilumab or placebo with TCS and assessed the percentage of patients considered responsive to dupilumab treatment at week 16.

resultsAt week 16, almost all patients receiving dupilumab + TCS (95%) demonstrated clinically meaningful improvements in AD signs, symptoms, or QoL compared with placebo + TCS (61%, p < 0.0001). Significant improvements were seen as early as week 2 and sustained through the end of the study in the full analysis set (FAS) and the subgroup of patients with an Investigator's Global Assessment score greater than 1 at week 16. LIMITATIONS: Limitations include the post hoc nature of the analysis and that some outcomes were not prespecified; the small number of patients in some subgroups potentially limits generalizability of findings.

conclusionTreatment with dupilumab provides significant and sustained improvements within 2 weeks in AD signs, symptoms, and QoL in almost all children with severe AD, including those who did not achieve clear or almost clear skin by week 16.

trial registrationNCT03345914. Video Abstract: Does dupilumab provide clinically meaningful responses in children 6 to 11 years old with severe atopic dermatitis? (MP4 99484 kb).

Indexed as

Dermatitis, AtopicDermatologic AgentsAntibodies, Monoclonal, HumanizedChildDouble-Blind MethodHumansInjections, SubcutaneousQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentsdupilumab

Identifiers

PMID37300760
PMCPMC10460374
OpenAlexW4380203089

What OpenQuestion holds

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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.