Evidence map›Paper›PMID 35442530›Full record

ArticleThe British journal of dermatology2022

The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.

Eric L Simpson, Robert Bissonnette, Amy S Paller, Brett King, Jonathan I Silverberg, Kristian Reich, Jacob P Thyssen, Helen Doll, Luna Sun, Amy M DeLozier and 2 more

3 registry-linked trialsAbstract read
In one paragraph

Article in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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.

NCT03334396 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2019Enrolled660ConditionsAtopic DermatitisArmsBaricitinib, Placebo
NCT03334422 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Patients With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2018Enrolled615ConditionsAtopic DermatitisArmsBaricitinib, Placebo
NCT03435081 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2021Enrolled440ConditionsAtopic DermatitisArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Defining "Flares" in Atopic Dermatitis: A Narrative Review.American journal of clinical dermatology · 2025
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. A study on the clinical manifestations in lepidopterism.Archives of dermatological research · 2025
    Article
  15. Article
  16. Effect of herbal medicineFrontiers in pharmacology · 2025
    Article
  17. Article
  18. Article
  19. Review
  20. 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

12 authors.

Eric L SimpsonOregon Health and Science University, Portland, OR, USA.
Robert BissonnetteInnovaderm Research Inc., Montreal, QC, Canada.
Amy S PallerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Brett KingYale School of Medicine, New Haven, CT, USA.ORCID 0000-0002-4576-4616
Jonathan I SilverbergGeorge Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID 0000-0003-3686-7805
Kristian ReichCenter for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0001-5248-4332
Jacob P ThyssenDepartment of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Helen DollClinical Outcomes Solutions, Folkestone, UK.
Luna SunEli Lilly and Company, Indianapolis, IN, USA.
Amy M DeLozierEli Lilly and Company, Indianapolis, IN, USA.
Fabio P NunesJanssen Global Services, LLC, PA; this work performed previously while at Eli Lilly and Company, Indianapolis, IN, USA.
Lawrence F EichenfieldUniversity of California San Diego School of Medicine, La Jolla, CA, USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Eli Lilly and Company N/ANCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundThe validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD).

objectivesTo investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD.

methodsData were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies.

resultsAcross studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P < 0·001). Responsiveness was demonstrated vs. EASI (P < 0·001 for much improved vs. improved and improved vs. stable). Anchor- and distribution-based methods supported a vIGA-AD change of -1·0 as clinically meaningful. These findings are limited to populations defined by the studies' inclusion and exclusion criteria.

conclusionsThe vIGA-AD demonstrated sufficient reliability, validity, responsiveness and interpretation standards for use in clinical trials. What is already known about this topic? A description of the development of the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) has been published previously. What does this study add? The current study validates the vIGA-AD by demonstrating appropriate test-retest reliability, convergent validity, known-groups validity and responsiveness across three baricitinib clinical studies. In addition, a 1-point change was identified as a clinically meaningful patient-perceived change minimal clinically important difference in the vIGA-AD. What are the clinical implications of the work? The vIGA-AD is a measure for investigator assessment of atopic dermatitis suitable for use in clinical research.

Indexed as

Dermatitis, AtopicAdultAzetidinesClinical Trials, Phase III as TopicHumansOutcome Assessment, Health CarePurinesPyrazolesReproducibility of ResultsSeverity of Illness IndexSulfonamidesAzetidinesbaricitinibPurinesPyrazolesSulfonamides

Identifiers

PMID35442530
PMCPMC9804170

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.