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
; 91(3): 457-465, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38777187
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Índice de Gravidade de Doença
/
Dermatite Atópica
/
Creme para a Pele
Limite:
Adolescent
/
Adult
/
Aged
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article