Evidence map›Paper›PMID 31641952›Full record

ArticleDermatology and therapy2019

Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children's Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis.

Eric L Simpson, Marjolein de Bruin-Weller, Laurent Eckert, Diane Whalley, Isabelle Guillemin, Matthew Reaney, Zhen Chen, Lauren Nelson, Shanshan Qin, Ashish Bansal and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03054428 (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), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 9% 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.

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
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

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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

11 authors at 6 institutions in 4 countries.

Eric L SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA. simpsone@ohsu.edu.
Marjolein de Bruin-WellerUniversity Medical Center Utrecht, Utrecht, The Netherlands.
Laurent EckertSanofi, Chilly-Mazarin, France.
Diane WhalleyRTI Health Solutions, Manchester, UK.
Isabelle GuilleminSanofi, Lyon, France.
Matthew ReaneySanofi, Guildford, UK.
Zhen ChenRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Lauren NelsonRTI Health Solutions, Durham, NC, USA.
Shanshan QinRTI Health Solutions, Durham, NC, USA.
Ashish BansalRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Abhijit GadkariRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Regeneron (United States) · USRTI Health Solutions · USSanofi (France) · FROregon Health & Science University · USSanofi (United Kingdom) · GBUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe Patient-Oriented Eczema Measure (POEM) assesses patient-reported frequency of atopic dermatitis (AD) symptoms, while the Children's Dermatology Life Quality Index (CDLQI) measures the impact of skin disease on health-related quality of life (HRQoL) in children. There is currently no threshold for clinically meaningful within-person change in POEM or CDLQI scores in adolescents. Here we empirically derive within-person thresholds of meaningful within-person change in POEM and CDLQI scores in adolescents with moderate-to-severe AD.

methodsData were used from a phase 3, randomized, double-blind, placebo-controlled trial of dupilumab in adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD. Anchor-based methods were employed using the mean change in POEM and CDLQI scores from baseline to week 16 linked with a 1-point improvement in Patient Global Assessment of Disease (PGAD), a score of "a little better" on the Patient Global Assessment of Treatment effect (PGAT), a 50-74% improvement from baseline in the Eczema Area and Severity Index (EASI-50-74), and a 1-point improvement in Investigator's Global Assessment (IGA) score.

resultsA mean change of - 7.8 and - 5.6 in the POEM score was associated with PGAD and PGAT anchors, respectively. EASI-50-74 was associated with a mean change in POEM score of - 8.2, while the IGA anchor was associated with a mean change of - 7.9 in POEM score. The mean changes in CDLQI score associated with PGAD and PGAT anchors were - 6.4 and - 6.6, respectively, while CDLQI mean scores changed by - 8.3 and - 8.0 for the EASI and IGA anchors, respectively.

conclusionIn adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD, a within-person change of 6-8 points in POEM and CDLQI scores, independently, can be considered a reasonable responder threshold for clinically meaningful change in each of the two scales, respectively.

trial registrationClinicalTrials.gov Identifier: NCT03054428.

fundingSanofi and Regeneron Pharmaceuticals, Inc.

Indexed as

AdolescentsAtopic dermatitisCDLQIDupilumabPOEMQuality of lifeResponder thresholdValidation

Identifiers

PMID31641952
PMCPMC6828922
OpenAlexW2981554886

What OpenQuestion holds

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LicenceCC BY-NC
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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.