Secondary Efficacy Outcomes from a Phase 2b, Randomized Dose-Finding Study of Tapinarof Cream for the Treatment of Plaque Psoriasis
Gold LS, Bhatia N, Tallman AM, and Rubenstein D. Secondary Efficacy Outcomes from a Phase 2b, Randomized Dose-Finding Study of Tapinarof Cream for the Treatment of Plaque Psoriasis. J Psoriasis Psoriatic Arthritis 2019; 4(3):162-163.
J Psoriasis Psoriatic Arthritis
Introduction: Tapinarof is a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for the treatment of psoriasis and atopic dermatitis. Study: This phase 2b, double-blind, 6-arm, vehicle-controlled randomized study (NCT02564042) assessed the efficacy and safety of tapinarof cream in patients with psoriasis. Patients (aged 18-65 years) with chronic stable plaque psoriasis (≥6 months), body surface area involvement ≥1 and ≤15% and Physician Global Assessment (PGA) score ≥2 at baseline were randomized 1:1:1:1:1:1 to tapinarof cream 0.5% or 1.0% once (QD) or twice daily (BID) or vehicle QD or BID for 12 weeks. Secondary efficacy outcomes reported here include mean change from baseline in PGA, 50% reduction in Psoriasis Area and Severity Index (PASI50), PASI90, target lesion grading scores, and pruritus numeric rating scale. Results: Of 227 patients randomized, 174 completed the study. Higher PASI50 and PASI90 response rates, and greater reductions in mean PGA and total target lesion grading scores were observed in tapinarof groups versus vehicle at week 12; results were maintained for 4 weeks after the end of study treatment. Most treatment-emergent adverse events were mild or moderate, and the most common (≥5%) across all groups were folliculitis (9%) and contact dermatitis (5%). Most incidences of folliculitis and contact dermatitis were mild or moderate. Conclusion: These results support the primary analysis showing that tapinarof cream was efficacious and well tolerated in adults with psoriasis. A phase 3 program is planned to further investigate tapinarof cream (1% QD) as a new treatment option for psoriasis.