Evidence map›Paper›PMID 42771135›Full record

ArticleDermatology and therapy2026

Development of a Conceptual Disease Model of Atopic Dermatitis Using Data from the Phase 3 ARCADIA 1 Trial.

Jonathan I Silverberg, Patrick Daniele, Danielle Rodriguez, Sarah Mulnick, Gil Yosipovitch, Lawrence F Eichenfield, Melinda Gooderham, Richard Warren, Ramkumar Subramanian, Katrin Jack and 4 more

Registry-linked trialAbstract read
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In one paragraph

Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03985943 (A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03985943 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorGalderma R&DRan2019 to 2022Enrolled941ConditionsModerate-to-Severe Atopic DermatitisArmsPlacebo, Nemolizumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Jonathan I SilverbergGeorge Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID http://orcid.org/0000-0003-3686-7805
Patrick DanielePPD Evidera Patient Centered Research, Thermo Fisher Scientific, Waltham, MA, USA.
Danielle RodriguezPPD Evidera Patient Centered Research, Thermo Fisher Scientific, Waltham, MA, USA.ORCID http://orcid.org/0000-0002-1135-6999
Sarah MulnickPPD Evidera Patient Centered Research, Thermo Fisher Scientific, Waltham, MA, USA.
Gil YosipovitchUniversity of Miami Miller School of Medicine, 1600 NW 10th Ave, Miami, FL, USA.
Lawrence F EichenfieldSan Diego School of Medicine, University of California, San Diego, CA, USA.
Melinda GooderhamSKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, ON, Canada.ORCID http://orcid.org/0000-0001-8926-0113
Richard WarrenDermatology Centre, Northern Care Alliance NHS Foundation Trust and Division of Musculoskeletal and Dermatological Sciences, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
Ramkumar SubramanianGalderma, Zählerweg 10, 6300, Zug, Switzerland.ORCID http://orcid.org/0009-0001-0060-9540
Katrin JackGalderma, Zählerweg 10, 6300, Zug, Switzerland.
Liliana UlianovGalderma, Zählerweg 10, 6300, Zug, Switzerland.ORCID http://orcid.org/0009-0001-2897-6895
Christophe PikettyGalderma, Zählerweg 10, 6300, Zug, Switzerland.ORCID http://orcid.org/0000-0002-9969-2478
Rajesh RoutGalderma, Zählerweg 10, 6300, Zug, Switzerland.
Jorge PuellesGalderma, Zählerweg 10, 6300, Zug, Switzerland. jorge.puelles@galderma.com.ORCID http://orcid.org/0000-0003-3493-1252

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with atopic dermatitis (AD) often experience severe skin disease, intense itching, sleep disturbance, and impaired quality of life (QoL). This study aimed to generate a clinically credible, data-driven conceptual disease model (CDM) of AD using baseline data from the phase 3 ARCADIA 1 trial of nemolizumab in patients with moderate-to-severe AD (NCT03985943).

methodsLatent constructs were defined for skin severity, itch severity, sleep disturbance, and QoL/health status using validated clinical outcome assessments (COAs). Baseline COA data were obtained for the adult intent-to-treat population in ARCADIA 1. Structural equation modelling was conducted to assess direct and indirect relationships among AD domains. Factor loadings were calculated to evaluate COA-to-latent construct relationships, and regression coefficients were calculated to ensure that constructs had clinically interpretable directionality. To achieve consensus on the final model structure, model development and refinement were complemented by a modified Delphi process. Dermatologists with extensive experience managing moderate-to-severe AD and conducting AD clinical trials iteratively reviewed COA selection and latent construct definitions and proposed directional pathways.

resultsCOA data from 807 adults with moderate-to-severe AD were used to generate the CDM. In the model, itch severity has a substantial impact on QoL, exerting both a direct effect (β = 0.427) and an indirect effect via sleep disturbance (itch severity → sleep disturbance: β = 0.702; sleep disturbance → QoL: β = 0.431). A significant bidirectional relationship between skin severity and itch severity is also observed (β = 0.367). COAs show strong loadings on their respective latent constructs.

conclusionsThe CDM identifies itch severity as a central driver of the patient burden in moderate-to-severe AD and supports prioritization of itch and sleep disturbance in clinical assessment, therapeutic planning, and outcome evaluation in AD. Our model, whose validity is strengthened by expert consensus, can potentially guide clinical decision-making and evaluation of treatment responses across key domains of AD burden.

Indexed as

Atopic dermatitisConceptual disease modelItch severityPruritusQuality of lifeStructural equation modeling

Identifiers

PMID42771135

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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.