A Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Plaque Psoriasis: Secondary Efficacy and Patient-Reported Outcomes.
Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for treatment of psoriasis and atopic dermatitis.In a phase IIb, double-blind, vehicle-controlled study, adults with plaque psoriasis were randomized to tapinarof cream 0.5% or 1% once (QD) or twice daily (BID) or vehicle QD or BID for 12 weeks with 4-week follow-up. Efficacy outcomes included Physician Global Assessment (PGA) scores, change in PGA and total target lesion grading scores, and proportion of subjects achieving ≥50%, ≥75%, and ≥90% reductions in Psoriasis Area and Severity Index scores from baseline (PASI50, 75, and 90).At week 12, improvements were observed in all tapinarof groups versus vehicle in PGA response, change in PGA and total target lesion grading scores, PASI50 (71-92% versus 10-32%), PASI75 (46-65% versus 5-16%), and PASI90 (18-40% versus 0%); all differences were statistically significant with tapinarof 1%QD. Tapinarof responses were apparent from week 2, with significant efficacy at week 8 maintained through week 16. Most adverse events were mild or moderate.Analyses reported require confirmation in larger prospective studies.Tapinarof may represent an important advance in the development of topical medicines for treatment of psoriasis.