Evidence map›Paper›PMID 34726270›Full record

ArticleThe British journal of dermatology2022

IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis.

A S Paller, J K L Tan, J Bagel, A B Rossi, B Shumel, H Zhang, A Abramova

9 registry-linked trialsOpen access · greenAbstract 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 9 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT01949311 phase3completednot on this map

An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2013 to 2022Enrolled2,733ConditionsAtopic DermatitisArmsDupilumab
NCT02260986 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled740ConditionsAtopic DermatitisArmsDupilumab, Placebo (for Dupilumab), Topical Corticosteroid (TCS)
NCT02277743 phase3completednot on this map

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled671ConditionsDermatitis, AtopicArmsDupilumab, Placebo (for Dupilumab)
NCT02277769 phase3completednot on this map

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled708ConditionsDermatitis, AtopicArmsDupilumab, Placebo (for Dupilumab)
NCT02395133 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients With Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2015 to 2016Enrolled422ConditionsAtopic DermatitisArmsDupilumab, Placebo
NCT02612454 phase3active not recruitingnot on this map

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2015 to 2026Enrolled880ConditionsAtopic DermatitisArmsDupilumab
NCT02755649 phase3completednot on this map

A Phase 3 Study Investigating the Efficacy, Safety, and Tolerability of Dupilumab Administered to Adult Patients With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Are Intolerant to Oral Cyclosporine A, or When This Treatment is Not Medically Advisable

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2016 to 2017Enrolled325ConditionsAtopic DermatitisArmsDupilumab, Matching Placebo
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
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

A S PallerDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.ORCID 0000-0001-6187-6549
J K L TanWindsor Clinical Research, Windsor, ON, Canada.ORCID 0000-0002-9624-4530
J BagelEczema Center of New Jersey, East Windsor, NJ, USA.ORCID 0000-0001-5241-0915
A B RossiSanofi Genzyme, Cambridge, MA, USA.ORCID 0000-0001-5345-678X
B ShumelRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0002-9285-8164
H ZhangRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
A AbramovaRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0001-7581-1359
Regeneron (United States) · USNorthwestern University · USSanofi (United States) · USWindsor Clinical Research · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccurate assessment of atopic dermatitis (AD) severity is critical when initiating and monitoring therapy. Use of existing research tools such as the Eczema Area and Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) is complex and time-consuming in clinical practice. A previous analysis found the product of validated Investigator's Global Assessment (vIGA) and affected body surface area (BSA) to be an accurate and practical tool for routine assessment of paediatric AD.

objectiveTo evaluate the IGAxBSA composite as an alternative to EASI or SCORAD for assessment of AD disease severity and disease responsiveness.

methodsThe relationship between IGAxBSA, EASI and SCORAD was assessed in a post hoc analysis of pooled data from the dupilumab clinical trial programme in adult and paediatric patients with moderate-to-severe AD who had received dupilumab or placebo, with or without topical corticosteroids (TCS). The trials are registered at ClinicalTrials.gov and EudraCT: LIBERTY AD SOLO 1 (NCT02277743, 2014-001198-15), LIBERTY AD SOLO 2 (NCT02277769, 2014-002619-40), LIBERTY AD SOLO-CONTINUE (NCT02395133, 2014-003384-38), LIBERTY AD CHRONOS (NCT02260986, 2013-003254-24), LIBERTY AD CAFÉ (NCT02755649, 2015-002653-35), LIBERTY AD ADOL (NCT03054428, 2015-004458-16), LIBERTY AD PEDS (NCT03345914, 2016-004997-16), LIBERTY AD OLE (NCT01949311, 2013-001449-15) and LIBERTY AD PEDS OLE (NCT02612454, 2015-001396-40).

resultsUsing datapoints from pooled dupilumab randomized controlled trials (n = 3473) and open-label extension trials (n = 3045), we found that IGAxBSA correlated well with EASI and SCORAD, irrespective of treatment group and race (white, Asian, black). IGAxBSA correlated better with objective measures (EASI, SCORAD) than with patient- or caregiver-reported subjective measures. IGAxBSA correlated strongly with EASI and SCORAD in assessing disease change over time (r = 0·90, r = 0·76, respectively; P < 0·0001), and concordance between IGAxBSA-50/75/90 and EASI-50/75/90 was excellent (88-94%).

conclusionsIGAxBSA is a valid alternative for assessment of AD disease severity and response over time, compared with EASI or SCORAD in patients with AD, irrespective of race.

Indexed as

Dermatitis, AtopicDermatologic AgentsAdultChildHumansSeverity of Illness IndexTreatment OutcomeDermatologic Agents

Identifiers

PMID34726270
PMCPMC9303952
OpenAlexW3211175351

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

and 3 more above

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.