An analysis of PSOARING 1 and 2 data show the topical therapy is efficacious across a wide spectrum of psoriatic disease and patient demographics.
Tapinarof cream 1% (VTAMA) provides consistent benefit for patients with psoriasis across a variety of baseline disease severity and demographic factors, according to a new assessment.
In data derived from a pair of pivotal phase 3 trials involving the Dermavant topical therapy, a team of US investigators reported the agent was associated with efficacy and tolerability for patients with differing physician global assessment (PGA) and percentage body surface area (BSA) scores at baseline.
Led by Leon Kircik, MD, founder and medical director of DermResearch and Physicians Skin Care, the team of investigators assessed data from the phase 3 PSOARING 1 and PSOARING 2 clinical trials—from the pivotal program supporting tapinarof cream’s application and acceptance for use in treating psoriasis from the US Food and Drug Administration (FDA).
The supporting findings from the PSOARING program were “unheard of in a topical medicine” prior to tapinarof, Dermavant chief executive officer Todd Zavodnick told HCPLIve earlier this year.
“When you talk about remittance and staying clear for that time, you're always talking about injectable medicine,” Zavodnick said at the time. “And we're talking about a topical, that's going to allow cost control within a category and the ability to move from steroids to nonsteroidals.”
PSOARING 1 and 2 showed a once-daily regimen of the topical cream provided statistically significant benefit at 12 weeks versus vehicle in adults with mild to severe plaque psoriasis. Kircik and colleagues sought results for the trials’ primary efficacy endpoint of PGA response by scores of 0 or 1, or ≥2-grade improvement from baseline to week 12, based on baseline characteristics including PGA score, BSA, and duration of disease. They additionally sought efficacy data based on patient sex, age, race and country of enrollment—either US or Canada.
Patients with baseline PGA scores of ≥2 and BSA involvement ≥3 to ≥20% had been randomized 2:1 to tapinarof cream 1% or vehicle treatment for 12 weeks. The pooled analysis from Kircik and colleagues included 683 patients on therapy and 342 control patients.
A majority (82%) of patients had a PGA score of 3, indicating moderate disease, psoriasis for >10 years (57%), were male (57%), aged <65 years old (86%), White (85%), and enrolled in the US (76%). Just 26% had BSA ≥10% at baseline.
Investigators observed a PGA response outcome of 38.6% among treated patients versus 9.3% in vehicle among patients with baseline BSA <10%. PGA response outcome was observed in 35.6% of treated patients with baseline BSA ≥10% versus 9.3% of patients on vehicle.
PGA response was met by 34.8% of patients on tapinarof versus 7.8% on vehicle among those with <5 year disease duration. Such outcomes were 36.9% and 4.1%, respectively, among patients with baseline disease duration of 5-10 years, and 39.3% and 6.5%, respectively, among patients with baseline duration of >10 years.
Kircik and colleagues additionally observed a consistent PGA response among patients treated with tapinarof cream versus vehicle across sex, age, race and their country of enrollment.
“Tapinarof cream 1% once-daily was consistently efficacious and well tolerated irrespective of baseline PGA score, BSA affected, duration of psoriasis, sex, age, race and country of enrollment,” investigators concluded, “supporting its use across a broad spectrum of disease severity and patient populations.”
The study, “Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Efficacy by Baseline Disease Characteristics and Demographics in Two Pivotal Phase 3 Trials,” was published online in JDPA.