25750 Tapinarof cream 1% once daily for plaque psoriasis: Secondary efficacy outcomes from two pivotal phase 3 trials
Gold LS, Blauvelt A, Armstrong A, Desai SR, Sofen H, Green LJ, Tyring SK, Ferris LK, Brown PM, Rubenstein DS, and Piscitelli SC. 25750 Tapinarof cream 1% once daily for plaque psoriasis: Secondary efficacy outcomes from two pivotal phase 3 trials. J Am Acad Dermatol 2021; 85(3):AB69.
J Am Acad Dermatol
Tapinarof is a novel therapeutic aryl hydrocarbon receptor modulating agent (TAMA) in development for treatment of psoriasis and atopic dermatitis. Tapinarof cream 1% once daily (QD) demonstrated highly statistically significant efficacy vs vehicle QD at 12 weeks and was well-tolerated in adults with mild to severe plaque psoriasis in two identical Phase 3 trials: PSOARING 1 (N = 510) and PSOARING 2 (N = 515). Here, we present secondary efficacy endpoints, including Physician Global Assessment (PGA) scores, body surface area (BSA) affected, and ≥90% reduction in Psoriasis Area and Severity Index (PASI90) – an endpoint more commonly assessed for systemic agents. Mean overall baseline PASI was 8.9 and 9.1 and BSA affected was 7.9% and 7.6% in PSOARING 1 and 2, respectively. At Week 12, significantly more patients achieved PGA score of 0 or 1 with tapinarof vs vehicle: 37.8% vs 9.9% (P =.0001) and 43.6% vs 8.1% (P ˂.0001); and mean BSA affected was significantly reduced with tapinarof vs vehicle: −3.5 vs −0.2 and −4.2 vs 0.1 (both P ˂.0001). A significantly higher proportion of tapinarof-treated patients achieved PASI90 at Week 12 vs vehicle: 18.8% vs 1.6% (P =.0005) and 20.9% vs 2.5% (P ˂.0001). All secondary endpoints were highly statistically significant, confirming the efficacy on the primary endpoint. Tapinarof significantly improved all measures of disease activity and showed clear and consistent separation vs vehicle. Tapinarof cream has the potential to provide physicians and patients with a novel nonsteroidal topical treatment option that is effective and well-tolerated.