TY - JOUR
T1 - Rapid Onset of Itch Relief With Tapinarof in Two Phase 3 Trials in Atopic Dermatitis
AU - Simpson, Eric L.
AU - Silverberg, Jonathan I.
AU - Bissonnette, Robert
AU - Stein Gold, Linda
AU - Armstrong, April
AU - Hebert, Adelaide A.
AU - Serrao, Rocco T.
AU - Jakus, Jeannette R.
AU - Brown, Philip M.
AU - Rubenstein, David S.
AU - Piscitelli, Stephen C.
AU - Tallman, Anna M.
AU - Eichenfield, Lawrence F.
N1 - Publisher Copyright:
Copyright © 2025.
PY - 2025/6
Y1 - 2025/6
N2 - 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. Do Not Copy Methods: Eight hundred thirteen (813) patients were randomized Penalties to tapinarof Apply 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).
AB - 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. Do Not Copy Methods: Eight hundred thirteen (813) patients were randomized Penalties to tapinarof Apply 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).
UR - https://www.scopus.com/pages/publications/105008301739
U2 - 10.36849/JDD.8860R1
DO - 10.36849/JDD.8860R1
M3 - Article
C2 - 40465504
AN - SCOPUS:105008301739
SN - 1545-9616
VL - 24
SP - 600
EP - 607
JO - Journal of Drugs in Dermatology
JF - Journal of Drugs in Dermatology
IS - 6
ER -