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Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older
INTRODUCTION: In phase III trials in adolescents and children with atopic dermatitis (AD), dupilumab significantly decreased global disease severity. However, the effects of dupilumab on the extent and signs of AD across different anatomical regions were not reported. Here we characterize the effica...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484382/ https://www.ncbi.nlm.nih.gov/pubmed/34427891 http://dx.doi.org/10.1007/s13555-021-00568-y |
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author | Simpson, Eric L. Paller, Amy S. Siegfried, Elaine C. Thaçi, Diamant Wollenberg, Andreas Cork, Michael J. Marcoux, Danielle Huang, Rui Chen, Zhen Rossi, Ana B. Shumel, Brad Sierka, Debra Bansal, Ashish |
author_facet | Simpson, Eric L. Paller, Amy S. Siegfried, Elaine C. Thaçi, Diamant Wollenberg, Andreas Cork, Michael J. Marcoux, Danielle Huang, Rui Chen, Zhen Rossi, Ana B. Shumel, Brad Sierka, Debra Bansal, Ashish |
author_sort | Simpson, Eric L. |
collection | PubMed |
description | INTRODUCTION: In phase III trials in adolescents and children with atopic dermatitis (AD), dupilumab significantly decreased global disease severity. However, the effects of dupilumab on the extent and signs of AD across different anatomical regions were not reported. Here we characterize the efficacy of dupilumab in improving the extent and signs of AD across four different anatomical regions in children and adolescents. METHODS: A post hoc subset analysis was performed using data from two randomized, double-blind, placebo-controlled, international multicenter, phase III trials of dupilumab therapy in adolescents aged ≥ 12 to < 18 years with moderate-to-severe AD and children aged ≥ 6 to < 12 years with severe AD. Endpoints included mean percentage change in Eczema Area and Severity Index (EASI) signs (erythema, edema/papulation, excoriation, lichenification) and extent of AD (measured by percentage of body surface area [% BSA] involvement) from baseline to week 16 across four anatomical regions (head and neck, trunk, upper extremities, lower extremities). RESULTS: Dupilumab improved both the extent and severity of AD signs across the four anatomical regions. Improvements were shown to be similar across the four anatomical regions for % BSA involvement and for reduction in EASI signs. Improvements in all signs were seen early, within the first 4 weeks of treatment, and were sustained through week 16, across all regions. CONCLUSIONS: In pediatric patients 6 years of age and older, treatment with dupilumab resulted in rapid and consistent improvement in the extent and signs of AD across all anatomical regions. CLINICALTRIALS.GOV IDENTIFIERS: LIBERTY AD ADOL (NCT03054428) and LIBERTY AD PEDS (NCT03345914). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-021-00568-y. |
format | Online Article Text |
id | pubmed-8484382 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-84843822021-10-08 Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older Simpson, Eric L. Paller, Amy S. Siegfried, Elaine C. Thaçi, Diamant Wollenberg, Andreas Cork, Michael J. Marcoux, Danielle Huang, Rui Chen, Zhen Rossi, Ana B. Shumel, Brad Sierka, Debra Bansal, Ashish Dermatol Ther (Heidelb) Original Research INTRODUCTION: In phase III trials in adolescents and children with atopic dermatitis (AD), dupilumab significantly decreased global disease severity. However, the effects of dupilumab on the extent and signs of AD across different anatomical regions were not reported. Here we characterize the efficacy of dupilumab in improving the extent and signs of AD across four different anatomical regions in children and adolescents. METHODS: A post hoc subset analysis was performed using data from two randomized, double-blind, placebo-controlled, international multicenter, phase III trials of dupilumab therapy in adolescents aged ≥ 12 to < 18 years with moderate-to-severe AD and children aged ≥ 6 to < 12 years with severe AD. Endpoints included mean percentage change in Eczema Area and Severity Index (EASI) signs (erythema, edema/papulation, excoriation, lichenification) and extent of AD (measured by percentage of body surface area [% BSA] involvement) from baseline to week 16 across four anatomical regions (head and neck, trunk, upper extremities, lower extremities). RESULTS: Dupilumab improved both the extent and severity of AD signs across the four anatomical regions. Improvements were shown to be similar across the four anatomical regions for % BSA involvement and for reduction in EASI signs. Improvements in all signs were seen early, within the first 4 weeks of treatment, and were sustained through week 16, across all regions. CONCLUSIONS: In pediatric patients 6 years of age and older, treatment with dupilumab resulted in rapid and consistent improvement in the extent and signs of AD across all anatomical regions. CLINICALTRIALS.GOV IDENTIFIERS: LIBERTY AD ADOL (NCT03054428) and LIBERTY AD PEDS (NCT03345914). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-021-00568-y. Springer Healthcare 2021-08-24 /pmc/articles/PMC8484382/ /pubmed/34427891 http://dx.doi.org/10.1007/s13555-021-00568-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Simpson, Eric L. Paller, Amy S. Siegfried, Elaine C. Thaçi, Diamant Wollenberg, Andreas Cork, Michael J. Marcoux, Danielle Huang, Rui Chen, Zhen Rossi, Ana B. Shumel, Brad Sierka, Debra Bansal, Ashish Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title | Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title_full | Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title_fullStr | Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title_full_unstemmed | Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title_short | Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older |
title_sort | dupilumab demonstrates rapid and consistent improvement in extent and signs of atopic dermatitis across all anatomical regions in pediatric patients 6 years of age and older |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484382/ https://www.ncbi.nlm.nih.gov/pubmed/34427891 http://dx.doi.org/10.1007/s13555-021-00568-y |
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