Evidence map›Paper›PMID 40971133›Full record

Observational studyAmerican journal of clinical dermatology2025

Systemic Treatments in Moderate-to-Severe Atopic Dermatitis in Pediatric Patients up to 12 Years of Age: Real-World Treatment Outcomes from the PEDISTAD Registry.

Amy S Paller, Danielle Marcoux, Michele Ramien, Eulalia Baselga, Vania Oliveira Carvalho, Ledit R F Ardusso, Marlies de Graaf, Suzanne Pasmans, Mirna Toledo-Bahena, Cory Rubin and 6 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in American journal of clinical dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03687359 (Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable), 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.

NCT03687359 active not recruitingnot on this map

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Typeobservational_patient_registrySponsorSanofiRan2019 to 2035Enrolled1,860ConditionsDermatitis AtopicArmsStandard of care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

16 authors.

Amy S PallerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA. apaller@northwestern.edu.ORCID http://orcid.org/0000-0001-6187-6549
Danielle MarcouxDepartment of Pediatrics, Division of Dermatology, University of Montreal, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0003-2079-9166
Michele RamienSection of Community Pediatrics, Department of Pediatrics, Alberta Children's Hospital, Calgary, Alberta, Canada.ORCID http://orcid.org/0000-0001-9191-3611
Eulalia BaselgaHospital Sant Joan de Déu, Barcelona, Spain.ORCID http://orcid.org/0000-0003-1086-8439
Vania Oliveira CarvalhoClinical Hospital, Federal University of Paraná, Paraná, Brazil.ORCID http://orcid.org/0000-0002-4578-8781
Ledit R F ArdussoAllergy and Immunology Department, Rosario School of Medicine, National University of Rosario, Rosario, Argentina.ORCID http://orcid.org/0000-0002-4179-2126
Marlies de GraafUniversity Medical Center Utrecht, Utrecht, Netherlands.ORCID http://orcid.org/0000-0001-9004-5111
Suzanne PasmansErasmus MC University Medical Center Rotterdam, Sophia Children's Hospital, Rotterdam, Netherlands.ORCID http://orcid.org/0000-0003-1018-4475
Mirna Toledo-BahenaDepartment of Dermatology, Hospital Infantil de México Federico Gómez, México City, México.ORCID http://orcid.org/0000-0001-9132-9001
Cory RubinMichigan Dermatology Institute, Waterford, MI, USA.
Joel C JoyceDivision of Dermatology, Department of Health, Endeavor Health, Evanston, IL, USA.
Lara Wine LeeDermatology and Dermatologic Surgery, Medical University of South Carolina, Charleston, SC, USA.ORCID http://orcid.org/0000-0001-6739-4508
Rajan GuptaSanofi, Cambridge, MA, USA.
Bryan AdamsSanofi, Cambridge, MA, USA.
Marius ArdeleanuRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.ORCID http://orcid.org/0000-0002-7712-6862
Annie ZhangSanofi, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtopic dermatitis (AD), a chronic systemic disease, can cause intense skin itching and negatively impact sleep, mood, and quality of life (QoL) for patients and families.

methodsPEDISTAD is an ongoing, 10-year, observational registry describing disease characteristics, atopic comorbidities, and treatment patterns in pediatric patients (aged <12 years at enrollment) with moderate-to-severe AD. This 3-year interim analysis evaluates clinician-reported and caregiver-reported/patient-reported outcomes (Eczema Area and Severity Index [EASI], percent body surface area affected, worst itching/scratching, Children's Dermatology Life Quality Index, and Dermatitis Family Impact) in children treated with dupilumab, methotrexate, and/or cyclosporine. Outcomes were assessed as change from therapy start to last observation (either data cutoff date or treatment discontinuation).

resultsMean (±SE) EASI scores at the time of the last 3-year interim observation were consistent with mild disease in the dupilumab cohort and moderate disease in the methotrexate and cyclosporine cohorts. Improvements in pruritus were numerically greater in the dupilumab cohort relative to the methotrexate and cyclosporine cohorts, while improvements in QoL were similar in the dupilumab and methotrexate cohorts, with no significant change in the cyclosporine cohort. Rates of AD exacerbation were numerically lower with dupilumab treatment relative to methotrexate treatment which were numerically lower than cyclosporine treatment. Dupilumab discontinuation rates were numerically lower relative to methotrexate which were numerically lower than cyclosporine.

conclusionsThis PEDISTAD 3-year interim analysis of dupilumab, methotrexate, and cyclosporine treatment in children with AD demonstrates numerically greater improvements in AD signs, symptoms and QoL with dupilumab treatment relative to methotrexate and cyclosporine [Video abstract and graphical abstract available]. CLINICAL

trial registrationNCT03687359. Supplementary file1 (MP4 58163 KB).

Indexed as

Dermatitis, AtopicDermatologic AgentsPruritusAntibodies, Monoclonal, HumanizedChildChild, PreschoolCyclosporineFemaleHumansInfantMaleMethotrexatePatient Reported Outcome MeasuresQuality of LifeRegistriesSeverity of Illness IndexAntibodies, Monoclonal, HumanizedCyclosporineDermatologic AgentsdupilumabMethotrexate

Identifiers

PMID40971133
PMCPMC12615528

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.