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). 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.

© 2021. The Author(s).

Figures

Fig. 1

Analysis of value in EASI regional scoresa (from baseline to week 16)b. aEASI regional scores nonweighted for % BSA. bFor graphical purposes, figures have been constructed to represent the right side of the body being treated with placebo and the left side being treated with dupilumab. In patients receiving dupilumab, similar responses were achieved on both sides of the body. BSA body surface area, EASI Eczema Area and Severity Index, LS least squares, q2w every 2 weeks, q4w every 4 weeks, TCS topical corticosteroid

Fig. 2

LS mean percentage change in EASI regional scorea from baseline to week 16 by visit in four anatomical regions. *p < 0.05; **p < 0.001; ***p < 0.0001; vs. corresponding placebo. aEASI regional scores weighted for % BSA. BSA body surface area, EASI Eczema Area and Severity Index, LS least squares, q2w every 2 weeks, q4w every 4 weeks, SE standard error, TCS topical corticosteroid

Fig. 3

Median percentage change in BSA affecteda from baseline to week 16 by visit in four anatomical regions. *p < 0.05; **p < 0.001; ***p < 0.0001; vs. corresponding placebo. aThe median difference and 95% CI were calculated with the Hodges–Lehmann method. The median estimates and 95% CI were calculated with the quantile regression method. BSA body surface area, CI confidence interval, q2w every 2 weeks, q4w every 4 weeks, TCS topical corticosteroid

Fig. 4

LS mean percentage change from baseline in EASI sign scorea (erythema) in four anatomical regions. *p < 0.05; **p < 0.001; ***p < 0.0001; vs. corresponding placebo. aEASI sign score is calculated as composite of the intensity (0–3) and extent of involvement (0–6). EASI Eczema Area and Severity Index, LS least squares, q2w every 2 weeks, q4w every 4 weeks, SE standard error, TCS topical corticosteroid