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

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.