Long-term treatment with Vtama cream safe, effective for plaque psoriasis
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Results of a long-term efficacy study showed that treatment with Vtama for plaque psoriasis provided improvement beyond 12 weeks with nearly half of patients achieving full clearance.
Bruce Strober, MD, PhD, of Yale University, and colleagues wrote in their study, published in the Journal of American Academy of Dermatology, that loss of effectiveness over time with topical treatments has been reported often and there have been no topicals with a novel mechanism of action approved by the FDA for more than 25 years.
To assess long-term safety, efficacy and response durability of once-daily treatment with Vtama (tapinarof cream 1%, Dermavant Sciences), the researchers enrolled 763 patients who had completed 12 weeks of treatment and began a 40-week open-label trial with 4 weeks of follow-up.
Strober and colleagues noted that patients who had been previously treated with tapinarof had lower percentages of body surface area affected by psoriasis and lower PGA scores at baseline.
They found that adverse events, which were mostly mild and moderate, were consistent with previous trials. The most frequent treatment-emergent adverse events were folliculitis (22.7%), contact dermatitis (5.5%) and upper respiratory tract infection (4.7%). The incidence of these events, however, did not increase or worsen with long-term treatment compared with previous trials.
Based on investigator assessment, more than 90% of patients had no irritation during all visits that took place over the 40-week study and patient-reported burning, stinging or itching was rated as low by 86% to 92% of patients. Additionally, tolerability was still high when tapinarof was applied to sensitive and intertriginous skin.
Overall, 40.9% of patients achieved complete disease clearance at least once during the trial, including 34.3% who began the trial with a PGA score of 1 or higher.
More specifically, patients who entered the 40-week trial who had a PGA score of 2 or higher and were previously treated with tapinarof for a shorter period achieved a PGA score of 0 or 1 at least once during the long-term trial.
“Continuous and intermittent use of tapinarof cream 1% [once daily] was safe and efficacious for up to 1 year in patients with mild to severe psoriasis,” Strober and colleagues wrote. “Durable efficacy on therapy and a substantial remittive effect of at least 4 months off therapy were demonstrated. Consequently, tapinarof cream 1% [once daily] may represent a novel, nonsteroidal topical therapy for patients with plaque psoriasis that is effective and well tolerated with long-term use.”
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