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Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis
INTRODUCTION: The 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 n...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6828922/ https://www.ncbi.nlm.nih.gov/pubmed/31641952 http://dx.doi.org/10.1007/s13555-019-00333-2 |
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author | Simpson, Eric L. de Bruin-Weller, Marjolein Eckert, Laurent Whalley, Diane Guillemin, Isabelle Reaney, Matthew Chen, Zhen Nelson, Lauren Qin, Shanshan Bansal, Ashish Gadkari, Abhijit |
author_facet | Simpson, Eric L. de Bruin-Weller, Marjolein Eckert, Laurent Whalley, Diane Guillemin, Isabelle Reaney, Matthew Chen, Zhen Nelson, Lauren Qin, Shanshan Bansal, Ashish Gadkari, Abhijit |
author_sort | Simpson, Eric L. |
collection | PubMed |
description | INTRODUCTION: The 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. METHODS: Data 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. RESULTS: A 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. CONCLUSION: In 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03054428. FUNDING: Sanofi and Regeneron Pharmaceuticals, Inc. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13555-019-00333-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6828922 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-68289222019-11-18 Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis Simpson, Eric L. de Bruin-Weller, Marjolein Eckert, Laurent Whalley, Diane Guillemin, Isabelle Reaney, Matthew Chen, Zhen Nelson, Lauren Qin, Shanshan Bansal, Ashish Gadkari, Abhijit Dermatol Ther (Heidelb) Brief Report INTRODUCTION: The 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. METHODS: Data 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. RESULTS: A 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. CONCLUSION: In 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03054428. FUNDING: Sanofi and Regeneron Pharmaceuticals, Inc. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13555-019-00333-2) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-10-22 /pmc/articles/PMC6828922/ /pubmed/31641952 http://dx.doi.org/10.1007/s13555-019-00333-2 Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Brief Report Simpson, Eric L. de Bruin-Weller, Marjolein Eckert, Laurent Whalley, Diane Guillemin, Isabelle Reaney, Matthew Chen, Zhen Nelson, Lauren Qin, Shanshan Bansal, Ashish Gadkari, Abhijit Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title | Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title_full | Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title_fullStr | Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title_full_unstemmed | Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title_short | Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis |
title_sort | responder threshold for patient-oriented eczema measure (poem) and children’s dermatology life quality index (cdlqi) in adolescents with atopic dermatitis |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6828922/ https://www.ncbi.nlm.nih.gov/pubmed/31641952 http://dx.doi.org/10.1007/s13555-019-00333-2 |
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