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Advancing Knowledge. Enhancing Care.

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EADV 2020 | Tapinarof Cream 1 Percent Once Daily for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials

Research 2020

Presented by Mark Lebwohl, MD

A report from the 29th Congress of the European Academy of Dermatology and Venereology

Intro and design: Two identical randomized, vehicle-controlled studies of tapinarof, a first-in-class, non-steroidal topical aryl hydrocarbon receptor modulating agent (TAMA). This study assessed PGA(0,1) and PASI-75 response in adults aged 18-75 with predominantly moderate psoriasis

Results: At week 12 both endpoints achieved, all outcomes with p < 0.0001:

  • Primary endpoint, PGA(0,1): 35.4% / 40.2% (tapinarof) vs 6.0% / 6.3% (vehicle)
  • Secondary Endpoint, PASI-75 response: 36.1% / 47.6% (tapinarof) vs 10.2% / 6.9% (vehicle).
Adverse effects: Most were mild-moderate. Discontinuation rate 5.6% and 5.8% in tapinarof arms, due to folliculitis (1.8% and 0.9%), contact dermatitis (1.5% and 2.0%), headache (0.3% and 0.6%).

Conclusion: Tapinarof cream demonstrates significant, clinically meaningful efficacy, and has the potential to be the first TAMA treatment option for psoriasis.

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