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

Eric L Simpson; Amy S Paller; Elaine C Siegfried; Diamant Thaçi; Andreas Wollenberg; Michael J Cork; Danielle Marcoux; Rui Huang; Zhen Chen; Ana B Rossi; Brad Shumel; Debra Sierka; Ashish Bansal

doi:10.1007/s13555-021-00568-y

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

Dermatol Ther (Heidelb). 2021 Oct;11(5):1643-1656. doi: 10.1007/s13555-021-00568-y. Epub 2021 Aug 24.

Authors

Eric L Simpson¹, Amy S Paller^{2

3}, Elaine C Siegfried^{4

5}, Diamant Thaçi⁶, Andreas Wollenberg⁷, Michael J Cork^{8

9}, Danielle Marcoux^{10

11}, Rui Huang¹², Zhen Chen¹³, Ana B Rossi¹³, Brad Shumel¹², Debra Sierka¹³, Ashish Bansal¹⁴

Affiliations

¹ Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
² Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
³ Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.
⁴ Saint Louis University, St. Louis, MO, USA.
⁵ Cardinal Glennon Children's Hospital, St. Louis, MO, USA.
⁶ Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
⁷ Ludwig-Maximilian University, Munich, Germany.
⁸ Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.
⁹ Sheffield Children's Hospital Clinical Research Facility, Sheffield, UK.
¹⁰ Department of Pediatrics, Université de Montréal, Montreal, QC, Canada.
¹¹ Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.
¹² Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
¹³ Sanofi Genzyme, Cambridge, MA, USA.
¹⁴ Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA. ashish.bansal@regeneron.com.

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). Does dupilumab provide improvement in atopic dermatitis across all anatomical regions in children and adolescents? (MP4 48,385 kb).

Keywords: Anatomical regions; Atopic eczema; Contact dermatitis; Cytokines; Dupilumab; Facial erythema; Immunology; Patients; Pediatric dermatology; Signs.

Associated data

ClinicalTrials.gov/NCT03054428
ClinicalTrials.gov/NCT03345914