@article{d8f50b5adb1b434aa6a4e52d3967ea31,
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",
abstract = "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). [MediaObject not available: see fulltext.]",
keywords = "Anatomical regions, Atopic eczema, Contact dermatitis, Cytokines, Dupilumab, Facial erythema, Immunology, Patients, Pediatric dermatology, Signs",
author = "Simpson, {Eric L.} and Paller, {Amy S.} and Siegfried, {Elaine C.} and Diamant Tha{\c c}i and Andreas Wollenberg and Cork, {Michael J.} and Danielle Marcoux and Rui Huang and Zhen Chen and Rossi, {Ana B.} and Brad Shumel and Debra Sierka and Ashish Bansal",
note = "Funding Information: Eric L. Simpson has been an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron Pharmaceuticals, Inc.; and received a consultant{\textquoteright}s honorarium from AbbVie, Boehringer Ingelheim, Dermavant, Eli Lilly, Fort{\'e} Biosciences, Incyte, LEO Pharma, Menlo Therapeutics, Pfizer, Pierre Fabre Dermo-Cosm{\'e}tique, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and Valeant. Amy S. Paller has been an investigator for AbbVie, AnaptysBio, Eli Lilly, Incyte, Janssen, Lenus Pharma, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., and UCB; and a consultant for AbbVie, Abeona Therapeutics, Almirall, Asana Biosciences, Boehringer Ingelheim, BridgeBio Pharma, Dermavant, Dermira, Eli Lilly, Exicure, Fort{\'e}, Galderma, Incyte, InMed Pharmaceuticals, Janssen, LEO Pharma, LifeMax, Novartis, Pfizer, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sol–Gel, and UCB. Elaine C. Siegfried has been a consultant for Dermavant, Eli Lilly, Pfizer, Regeneron Pharmaceuticals, Inc., and Verrica Pharmaceuticals; a member of data safety monitoring boards for GlaxoSmithKline, LEO Pharma, and Novan; and a Principal Investigator for Eli Lilly, Janssen, Regeneron Pharmaceuticals, Inc., Stiefel, and Verrica Pharmaceuticals. Diamant Tha{\c c}i has been a consultant, advisory board member, and/or investigator for AbbVie, Almirall, Amgen, Beiersdorf, Boehringer Ingelheim, Dermira, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, and UCB. Andreas Wollenberg has been an investigator for Beiersdorf, Eli Lilly, Galderma, LEO Pharma, MedImmune, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; a consultant for AbbVie, Almirall, Anacor Pharmaceuticals, Eli Lilly, Galapagos, Galderma, LEO Pharma, MedImmune, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; and received research grants from Beiersdorf, LEO Pharma, and Pierre Fabre. Michael J. Cork has been a consultant and/or advisory board member and/or received research grants from Astellas Pharma, Atopix, Boots, Dermavant, Eli Lilly, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, Kymab, L{\textquoteright}Oreal, LEO Pharma, Menlo, National Eczema Society, UK, Novartis, Oxagen, Perrigo (ACO Nordic), Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and UCB Pharma. Danielle Marcoux has been an investigator for AbbVie, Amgen, Eli Lilly, Janssen, LEO Pharma, Novartis, and Pfizer; a Principal Investigator for Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme; a consultant for AbbVie, Amgen, BMS, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and UCB; and a speaker for AbbVie, Amgen, BMS, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme. Rui Huang , Zhen Chen , Brad Shumel , and Ashish Bansal are employees and shareholders of Regeneron Pharmaceuticals, Inc. Ana B. Rossi and Debra Sierka are employees of and may hold stock and/or stock options in Sanofi Genzyme. Funding Information: The authors thank the patients and their families for their participation in these studies; their colleagues for their support; and Linda Williams (Regeneron Pharmaceuticals, Inc.), El-Bdaoui Haddad and Adriana Mello (Sanofi Genzyme) for their contributions. This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Funding Information: This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. The journal Rapid Service Fee was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = oct,
doi = "10.1007/s13555-021-00568-y",
language = "English (US)",
volume = "11",
pages = "1643--1656",
journal = "Dermatology and Therapy",
issn = "2190-9172",
publisher = "Springer Verlag",
number = "5",
}