Evidence map›Paper›PMID 34462864›Full record

Trial reportPaediatric drugs2021

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial.

Amy S Paller, Andreas Wollenberg, Elaine Siegfried, Diamant Thaçi, Michael J Cork, Peter D Arkwright, Melinda Gooderham, Xian Sun, John T O'Malley, Faisal A Khokhar and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Paediatric drugs, 2021. 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 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.9field-weighted citation impact, top 6% 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

14 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. How to Understand Personalized Medicine in Atopic Dermatitis Nowadays?International journal of molecular sciences · 2023
    Review
  11. Article
  12. Review
  13. Review
  14. 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

15 authors at 9 institutions in 4 countries.

Amy S PallerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Andreas WollenbergLudwig Maximilian University of Munich, Munich, Germany.
Elaine SiegfriedSaint Louis University, St. Louis, MO, USA.
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Michael J CorkSheffield Dermatology Research, University of Sheffield, Sheffield, UK.
Peter D ArkwrightLydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.
Melinda GooderhamProbity Medical Research, Peterborough, ON, Canada.
Xian SunRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, USA.
John T O'MalleySanofi, Cambridge, MA, USA.
Faisal A KhokharRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, USA.
Jignesh VakilSanofi, Bridgewater, NJ, USA.
Ashish BansalRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, USA.
Karli RosnerSanofi Genzyme, Cambridge, MA, USA.
Brad ShumelRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, USA.
Noah A LevitRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, USA. noah.levit@regeneron.com.ORCID http://orcid.org/0000-0002-0797-5121
Regeneron (United States) · USSanofi (United States) · USLudwig-Maximilians-Universität München · DENorthwestern University · USQueen's University · CASaint Louis University · USUniversity of Lübeck · DEUniversity of Manchester · GBUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies of dupilumab in adolescents and adults with moderate-to-severe atopic dermatitis (AD) showed no clinically meaningful adverse changes in laboratory parameters.

objectiveThe aim of this study was to assess laboratory outcomes in children aged 6-11 years with severe AD in a randomized, placebo-controlled, phase III trial of dupilumab.

methodsChildren aged 6-11 years with severe AD were randomized 1:1:1 to 16 weeks of dupilumab 300 mg every 4 weeks, 100 or 200 mg every 2 weeks, or matching placebo, all with concomitant topical corticosteroids (TCS). Blood samples were collected at baseline and Weeks 4, 8, and 16; urine samples were collected at baseline and Weeks 4 and 16.

resultsOf 367 patients enrolled in the study, 362 were included in the safety analysis, 351 completed study treatment, and 4 withdrew due to treatment-emergent adverse events not related to laboratory abnormalities. Both dupilumab + TCS groups showed overall trends toward increases in mean blood levels of eosinophils and alkaline phosphatase, and decreases in mean blood levels of platelets, neutrophils, and lactate dehydrogenase levels, without corresponding mean changes in the placebo + TCS group. None of these changes were associated with symptoms or clinically meaningful adverse outcomes, and none led to treatment modification. No clinically significant changes or trends were observed for other measured laboratory parameters.

conclusionThere were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.

trial registrationClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic dermatitis? (MP4 180482 kb).

Indexed as

Dermatitis, AtopicAdolescentAdultAntibodies, Monoclonal, HumanizedChildDouble-Blind MethodHumansLaboratoriesSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID34462864
PMCPMC8418591
OpenAlexW3169209842

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.