The FDA approved tapinarof cream 1% (VTAMA), a steroid-free topical cream applied once daily for the treatment of mild, moderate, or severe plaque psoriasis in adults. It is the first FDA-approved steroid-free topical medication in this class, according to Dermavant, the manufacturer.
In the pivotal phase 3 clinical trial program tapinarof met all primary and secondary end points and demonstrated highly significant improvement in the Physician Global Assessment (PGA) score compared with placebo, with 36% of patients versus 6% receiving placebo achieving PGA treatment success (clear or almost clear skin with a minimum 2-grade improvement at week 12) in the first trial, and 40% of patients versus 6% receiving placebo achieving PGA treatment success in the second trial achieving (P<.0001 for both trials). The median duration of clear or almost-clear skin was approximately 4 months after cessation of treatment with tapinarof, and durability of response up to 52 weeks was demonstrated with intermittent use of tapinarof cream, with no observation of loss of response while on therapy.
Tapinarof was safe and well-tolerated even on sensitive skin areas. The most common adverse reactions in individuals treated with tapinarof cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
For full prescribing information consult product labeling.
