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American Journal of Clinical Dermatology
Published in: American Journal of Clinical Dermatology 1/2020

Open Access 01-02-2020 | Atopic Dermatitis | Original Research Article

Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial

Authors: Amy S. Paller, Ashish Bansal, Eric L. Simpson, Mark Boguniewicz, Andrew Blauvelt, Elaine C. Siegfried, Emma Guttman-Yassky, Thomas Hultsch, Zhen Chen, Paola Mina-Osorio, Yufang Lu, Ana B. Rossi, Xinyi He, Mohamed Kamal, Neil M. H. Graham, Gianluca Pirozzi, Marcella Ruddy, Laurent Eckert, Abhijit Gadkari

Published in: American Journal of Clinical Dermatology | Issue 1/2020

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Abstract

Background

Atopic dermatitis is a chronic inflammatory condition with substantial burden and limited treatment options for adolescents with moderate-to-severe disease. Significantly more patients treated with dupilumab vs. placebo achieved Investigator’s Global Assessment 0/1 at week 16.

Objective

The objective of this study was to assess the impact of dupilumab treatment vs. placebo on the achievement of clinically meaningful improvements in atopic dermatitis signs, symptoms and quality of life.

Methods

R668-AD-1526 LIBERTY AD ADOL was a randomized, double-blinded, parallel-group, phase III clinical trial. Two hundred and fifty-one adolescents with moderate-to-severe atopic dermatitis received dupilumab 300 mg every 4 weeks (q4w; n = 84), dupilumab 200 or 300 mg every 2 weeks (q2w; n = 82), or placebo (n = 85). A post-hoc subgroup analysis was performed on 214 patients with Investigator’s Global Assessment > 1 at week 16. Measures of atopic dermatitis signs, symptoms, and quality of life were assessed. Clinically meaningful improvement in one or more of three domains of signs, symptoms, and quality of life was defined as an improvement of ≥ 50% in Eczema Area and Severity Index, ≥ 3 points in Peak Pruritus Numerical Rating Scale, or ≥ 6 points in the Children’s Dermatology Life Quality Index from baseline.

Results

Of patients receiving dupilumab q2w, 80.5% [66/82] experienced clinically meaningful improvements in atopic dermatitis signs, symptoms, or quality of life at week 16 (vs. placebo, 20/85 [23.5%], difference 57.0% [95% confidence interval 44.5–69.4]; q4w vs. placebo, 53/84 [63.1%], difference 39.6% [95% confidence interval 25.9–53.3]; both p < 0.0001). Results were similar in adolescents with Investigator’s Global Assessment > 1 at week 16 (q2w, 46/62 [74.2%] vs. placebo, 18/83 [21.7%], difference 52.5% [95% confidence interval 38.5–66.6]; q4w, 38/69 [55.1%] vs. placebo, difference 33.4% [95% confidence interval 18.7–48.1]; both p < 0.0001).

Conclusions

Dupilumab provided clinically meaningful improvements in signs, symptoms, and quality of life in adolescents with moderate-to-severe atopic dermatitis among patients with Investigator’s Global Assessment > 1 at week 16. Treatment responses should be interpreted in the context of such clinically relevant patient-reported outcome measures.

Trial Registration

ClinicalTrials.gov; NCT03054428.

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Metadata
Title
Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial
Authors
Amy S. Paller
Ashish Bansal
Eric L. Simpson
Mark Boguniewicz
Andrew Blauvelt
Elaine C. Siegfried
Emma Guttman-Yassky
Thomas Hultsch
Zhen Chen
Paola Mina-Osorio
Yufang Lu
Ana B. Rossi
Xinyi He
Mohamed Kamal
Neil M. H. Graham
Gianluca Pirozzi
Marcella Ruddy
Laurent Eckert
Abhijit Gadkari
Publication date
01-02-2020
Publisher
Springer International Publishing
Published in
American Journal of Clinical Dermatology / Issue 1/2020
Print ISSN: 1175-0561
Electronic ISSN: 1179-1888
DOI
https://doi.org/10.1007/s40257-019-00478-y

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