Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials

Document Type

Article

Publication Date

9-1-2024

Publication Title

Journal of the American Academy of Dermatology

Keywords

Humans, Dermatitis, Atopic, Male, Female, Adult, Severity of Illness Index, Adolescent, Skin Cream, Middle Aged, Young Adult, Infant, Treatment Outcome, Double-Blind Method, Drug Administration Schedule, Resorcinols, Pruritus, Child, Preschool, Aged, Stilbenes

Abstract

BACKGROUND: Tapinarof cream 1% once daily (QD), a topical aryl hydrocarbon receptor agonist, downregulates pro-inflammatory Th2 cytokines, upregulates skin-barrier components, and reduces oxidative stress.

OBJECTIVE: To assess tapinarof efficacy and safety in adults and children down to 2 years of age with atopic dermatitis (AD).

METHODS: Eight hundred and thirteen patients were randomized to tapinarof or vehicle QD in two 8-week phase 3 trials.

RESULTS: The primary efficacy endpoint, Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and ≥2-grade improvement from baseline at Week 8, was met with statistical significance in both trials: 45.4% versus 13.9% and 46.4% versus 18.0% (tapinarof vs vehicle; both P < .0001). Significantly superior Eczema Area and Severity Index 75 (EASI75) responses were also observed with tapinarof versus vehicle at Week 8: 55.8% versus 22.9% and 59.1% versus 21.2% (both P < .0001). Rapid improvements in patient-reported pruritus were also significant with tapinarof versus vehicle. Common adverse events (≥5%) of folliculitis, headache, and nasopharyngitis were mostly mild or moderate, with lower discontinuations due to adverse events in the tapinarof groups than with vehicle.

LIMITATIONS: Long-term efficacy was not assessed.

CONCLUSION: Tapinarof demonstrated highly significant efficacy and favorable safety and tolerability in a diverse population of patients with AD down to 2 years of age.

Medical Subject Headings

Humans; Dermatitis, Atopic; Male; Female; Adult; Severity of Illness Index; Adolescent; Skin Cream; Middle Aged; Young Adult; Infant; Treatment Outcome; Double-Blind Method; Drug Administration Schedule; Resorcinols; Pruritus; Child, Preschool; Aged; Stilbenes

PubMed ID

38777187

ePublication

ePub ahead of print

Volume

91

Issue

3

First Page

457

Last Page

465

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