A Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Plaque Psoriasis: Secondary Efficacy and Patient-Reported Outcomes

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Journal of the American Academy of Dermatology


BACKGROUND: Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for treatment of psoriasis and atopic dermatitis.

METHODS: 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).

RESULTS: 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.

LIMITATIONS: Analyses reported require confirmation in larger prospective studies.

CONCLUSIONS: Tapinarof may represent an important advance in the development of topical medicines for treatment of psoriasis.

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ePub ahead of print