Rapid Onset of Itch Relief With Tapinarof in Two Phase 3 Trials in Atopic Dermatitis

Document Type

Article

Publication Date

6-1-2025

Publication Title

Journal of drugs in dermatology

Keywords

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

Abstract

BACKGROUND: In the ADORING 1 and 2 phase 3 trials, tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in adults and children down to 2 years of age with atopic dermatitis (AD). Here we evaluate the time to onset of itch relief in the trials.

METHODS: Eight hundred thirteen (813) patients were randomized to tapinarof cream 1% or vehicle QD for 8 weeks. Pruritus relief was assessed by Peak Pruritus Numerical Rating Scale (PP-NRS) scores (daily and by visit at weeks 1, 2, 4, and 8).

RESULTS: Mean baseline PP-NRS scores in ADORING 1 and 2 were 6.7 and 6.8, respectively. Greater reductions in mean daily PP-NRS scores were observed for tapinarof vs vehicle as early as day 1, 24 hours after initial application (-1.2 vs -1.0; pooled post hoc analysis), with significant improvements at day 2 (-1.6 vs -1.1, P=0.0115). Daily pruritus improvements continued through week 8. Significantly greater reductions in mean weekly PP-NRS scores with tapinarof vs vehicle were demonstrated at week 1 in ADORING 1, -2.0 vs -1.2 (P< 0.0001) and ADORING 2, -2.0 vs -1.3 (P=0.0010), continuing through week 8, -4.1 vs -2.6 and -4.1 vs -2.4 (both P< 0.0001).

CONCLUSION: Tapinarof demonstrated rapid and clinically meaningful pruritus relief in patients with AD, with improvements starting 24 hours after initial application and statistically significant improvements at day 2.

CITATION: Simpson EL, Silverberg JI, Bissonnette R, et al. Rapid onset of itch relief with tapinarof in two phase 3 trials in atopic dermatitis. J Drugs Dermatol. 2025;24(6):600-607. doi:10.36849/JDD.8860R1.

Medical Subject Headings

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

PubMed ID

40465504

Volume

24

Issue

6

First Page

600

Last Page

607

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