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
Recommended Citation
Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, and Kircik L. 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. J Am Acad Dermatol 2024.
Document Type
Article
Publication Date
9-1-2024
Publication Title
Journal of the American Academy of Dermatology
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
