41574 Tapinarof Cream 1% Once Daily (QD) for Plaque Psoriasis: Psoriasis Area and Severity Index Score by Body Region for the PSOARING 1 and 2 Trials

Tapinarof cream 1% QD demonstrated statistically significant efficacy and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week, vehicle-controlled, pivotal, phase 3 trials, PSOARING 1 and 2. All primary and secondary efficacy endpoints were met, including ≥75% and ≥90% improvement in Psoriasis Area and Severity Index (PASI). PASI is a composite assessing psoriasis severity and extent across four regions (head/neck, trunk [includes genitalia], upper extremities, lower extremities [includes buttocks]); scores range from 0–72. Local efficacy, including hard-to-treat areas, can be evaluated using regional treatment responses. We present post hoc analyses of PASI by body region in these pivotal trials. At baseline, 79.2%–83.9% of patients had a Physician Global Assessment score of 3 (moderate) and mean PASI score of 8.9–9.1, respectively. At Week 12 from baseline, least squares (LS) mean overall PASI improvements for tapinarof versus vehicle in PSOARING 1 and 2 were: –5.7 vs –2.1 and –5.7 vs –0.8, respectively (both P<0.0001). LS mean changes from baseline in PASI scores by body region were: head/neck –4.8 vs –1.5 and –5.0 vs –1.7 (both P<0.0001); trunk –4.3 vs –1.5 and –4.6 vs –0.4 (both P<0.0001); upper extremities –7.1 vs –3.4 and –7.2 vs –1.4 both P<0.0001); and lower extremities –6.1 vs –2.0 and –6.0 vs –0.5 (both P<0.0001). Tapinarof cream 1% QD demonstrated consistent efficacy overall and across body regions as measured by PASI, supporting its use in patients with mild to severe plaque psoriasis irrespective of location, including intertriginous and sensitive skin.