Phase 4 results show Vtama cream efficacious in head, neck plaque psoriasis
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Key takeaways:
- The phase 4 study achieved the primary endpoint of a proportion of patients reaching clear or almost clear target lesions.
- Vtama also demonstrated rapid onset of efficacy, the secondary endpoint.
In new phase 4 results, Vtama cream 1% demonstrated strong, rapid efficacy for the treatment of adults with plaque psoriasis in the head and neck, Dermavant announced in a press release.
“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body,” Philip M. Brown, MD, JD, chief medical officer of Dermavant, said in the press release. “In this phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability and cosmetic elegance of Vtama cream even when used in hair-bearing areas such as the head and neck region.”
In this open-label, phase 4 study, 31 adults with head and neck plaque psoriasis were treated with Vtama (tapinarof) cream once daily for 12 weeks with a follow-up 1 week after study completion.
The study achieved the primary endpoint with 88.5% (n = 23/26) of Vtama-treated patients achieving a target lesion PGA success score of clear or almost clear and a 2-grade or more improvement from baseline by week 12.
Vtama also demonstrated rapid onset of efficacy, the secondary endpoint, with patients achieving clearance at a median time of 4 weeks. At week 12, 80.8% (n = 21/26) of adult patients achieved complete clearance of the target lesion and 96.2% (n = 25/26) achieved PASI 75.
According to the release, Vtama cream was well tolerated with the most common adverse reactions being folliculitis, contact dermatitis, headache sinusitis and seborrheic keratosis. No new safety signals were observed.