Evidence map›Paper›PMID 31595499›Full record

Trial reportThe British journal of dermatology2020

Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension.

M J Cork, D Thaçi, L F Eichenfield, P D Arkwright, T Hultsch, J D Davis, Y Zhang, X Zhu, Z Chen, M Li and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03054428 (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), which is not on this map. Cited by 57 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 4 pooled it
–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.

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
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
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  14. Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026
    Review
  15. Article
  16. Review
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  18. Observational
  19. 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

22 authors.

M J CorkThe University of Sheffield, Sheffield Children's Hospital, Sheffield, U.K.
D ThaçiUniversity of Lübeck, Lübeck, Germany.
L F EichenfieldUniversity of California San Diego, Rady Children's Hospital, San Diego, CA, U.S.A.
P D ArkwrightUniversity of Manchester, Royal Manchester Children's Hospital, Manchester, U.K.ORCID 0000-0002-7411-5375
T HultschSanofi Genzyme, Cambridge, MA, U.S.A.
J D DavisRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
Y ZhangRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
X ZhuRegeneron Pharmaceuticals, Inc., Basking Ridge, NJ, U.S.A.
Z ChenRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
M LiSanofi, Bridgewater, NJ, U.S.A.
M ArdeleanuRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
A TeperSanofi, Bridgewater, NJ, U.S.A.
B AkinladeRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.ORCID 0000-0003-2334-5717
A GadkariRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
L EckertSanofi, Chilly-Mazarin, France.ORCID 0000-0002-7801-4125
M A KamalRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
M RuddyRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
N M H GrahamRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
G PirozziSanofi, Bridgewater, NJ, U.S.A.
N StahlRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
A T DiCioccioRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
A BansalRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.ORCID 0000-0002-7371-6486

Funding

Regeneron PharmaceuticalsSanofi
6 · The paper itself

Abstract

backgroundDupilumab (monoclonal antibody inhibiting IL-4/IL-13 signalling) is approved for use in adolescents aged ≥ 12 years with inadequately controlled moderate-to-severe atopic dermatitis (AD). Dupilumab significantly improved AD signs/symptoms in a 16-week, randomised, placebo-controlled phase III trial in adolescents (NCT03054428).

objectivesTo characterize the pharmacokinetics of dupilumab, and long-term safety and efficacy in adolescents.

methodsThis was a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study with a phase III open-label extension (OLE) in adolescents with moderate-to-severe AD. In the phase IIa study, patients received one dupilumab dose (2 mg kg

resultsForty adolescents received dupilumab in the phase IIa study; 36 enrolled in the OLE. Dupilumab showed nonlinear, target-mediated pharmacokinetics. Mean ± SD trough dupilumab concentrations in serum at week 48 (OLE) were 74 ± 19 mg L

conclusionsIn adolescents with moderate-to-severe AD, dupilumab's pharmacokinetic profile was similar to that in adults. These 52-week safety and efficacy data support long-term use of dupilumab in this patient population. What's already known about this topic? Adolescents with moderate-to-severe atopic dermatitis (AD) have high unmet medical need, with significant disease burden and limited treatment options. Dupilumab (monoclonal antibody against interleukin-4 receptor α) is approved for the treatment of adolescents with moderate-to-severe AD who are inadequately responsive to standard of care (U.S.A.) or candidates for systemic therapy (European Union). A 16-week, randomized, placebo-controlled phase III trial in adolescents demonstrated significant improvements in AD signs/symptoms with an acceptable safety profile. What does this study add? These studies demonstrate the long-term safety and efficacy of dupilumab in adolescents with moderate-to-severe AD for up to 52 weeks of treatment, thus extending and reinforcing the findings from the 16-week dupilumab phase III trial. The data from these studies also support the use of dupilumab in combination with current standard of care (topical corticosteroids), which was not evaluated in the 16-week phase III monotherapy trial.

Indexed as

Dermatitis, AtopicEczemaAdolescentAntibodies, Monoclonal, HumanizedCohort StudiesDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID31595499
PMCPMC6972638

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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.