Evidence map›Paper›PMID 32969489›Full record

Trial reportThe British journal of dermatology2021

Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study.

M J Cork, D Thaçi, L F Eichenfield, P D Arkwright, X Sun, Z Chen, B Akinlade, S Boklage, I Guillemin, M P Kosloski and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
8.3field-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.

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

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026
    Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Observational
  14. Review
  15. Article
  16. Review
  17. Pustular Psoriasis Induced by Dupilumab: A Case Report.Journal of inflammation research · 2024
    Article
  18. Article
  19. Article
  20. Unanswered questions on the use of biologics in pediatric asthma.The World Allergy Organization journal · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 4 countries.

M J CorkSheffield Dermatology Research, Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK.
D ThaçiInstitute and Comprehensive Center of Inflammation Medicine, University of Lübeck, Lübeck, Germany.
L F EichenfieldDepartments of Dermatology, University of California San Diego School of Medicine, San Diego, CA, USA.
P D ArkwrightLydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.ORCID 0000-0002-7411-5375
X SunRegeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA.
Z ChenRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
B AkinladeRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0003-2334-5717
S BoklageRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
I GuilleminSanofi, Chilly Mazarin, France.
M P KosloskiRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
M A KamalRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
J T O'MalleySanofi, Cambridge, MA, USA.
N PatelSanofi, Cambridge, MA, USA.
N M H GrahamRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
A BansalRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0002-7371-6486
Regeneron (United States) · USSanofi (United States) · USSanofi (France) · FRSheffield Children's Hospital · GBUniversity of Lübeck · DEUniversity of Manchester · GBUniversity of San Diego · US

Funding

NIHR Manchester Clinical Research Facility, Royal Manchester Children's Hospital, U.K.Regeneron PharmaceuticalsSanofi
6 · The paper itself

Abstract

backgroundChildren aged ≥ 6 to < 12 years with severe atopic dermatitis (AD) have limited treatment options. In a 16-week, randomized, placebo-controlled, phase III trial in children, dupilumab, a monoclonal antibody inhibiting interleukin (IL)-4/IL-13 signalling, significantly improved signs and symptoms with acceptable safety; longer-term safety and efficacy data are lacking.

objectivesTo report the pharmacokinetic profile and long-term safety and efficacy of dupilumab in children (aged ≥ 6 to < 12 years) with severe AD.

methodsChildren (aged ≥ 6 to < 12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study and subsequent open-label extension (OLE) study. Patients received single-dose dupilumab 2 or 4 mg kg

resultsOf 38 children enrolled, 37 completed phase IIa and 33 continued to the OLE. Nonlinear, target-mediated pharmacokinetics characterized dupilumab concentrations (week 24-48 mean serum concentrations: 2 mg kg

conclusionsThese safety and efficacy results support the use of dupilumab as a continuous long-term treatment for children aged ≥ 6 to < 12 years with severe AD.

Indexed as

Dermatitis, AtopicAntibodies, Monoclonal, HumanizedChildCohort StudiesDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID32969489
PMCPMC8247037
OpenAlexW3087781368

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.