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The topical drug was associated with adverse events that were mainly localized to the application site and mild to moderate in nature.
New data from Phase 3 trials of the nonsteroidal topical aryl hydrocarbon receptor-modulating agent tapinarof found that the cream, when administered once daily, was superior to vehicle control in reducing the severity of plaque psoriasis over a 12 week period.
However, tapinarof 1% was also associated with local adverse events and headaches.
Early reports of phase 2b dose-finding trial concluded with taponarof cream being deemed efficacious in adults with plaque psoriasis.
For the 2 phase 3 trials, PSOARING 1 and PSOARING 2, Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, and fellow investigators assessed the efficacy and safety of tapinarof 1% cream once daily in patients with plaque psoriasis.
PSOARING1 and 2 were identical, phase 3, multi-center, randomized, double-blind, vehicle-controlled trials.
Both trials were conducted at a total of 97 sites that spanned the United States and Canada, and involved patients 18 to 75 years of age.
A maximum screening period of 34 days was completed during the trials, resulting in a total of 692 patients for trial 1 and 674 patients for trial 2. A total of 510 and 515 adult patients with a baseline Physician’s Global Assessment (PGA) score of 2 (mild) to 4 (severe) were enrolled in each respective trial.
From there, eligible patients were randomly assigned in a 2:1 ratio to be treated with either tapinarof 1% cream or a vehicle cream, with stratification according to the baseline Physicians’ Global Assessment (PGA) score, with a score of 2 being “mild” and 4 being “severe” (based on a scale of 0 to 4).
With the exception of mornings of trial visits, patients were allowed to use nonmedicated emollients on non-lesioned skin, though skin lesions could only be treated with trial cream.
Medications that were prohibited during the trial and for a minimum period before baseline were biologic agents and other systemic treatments such as apremilast, methotrexate, and glucocorticoids for 4 weeks before baseline.
Trial visits occurred during weeks 2, 4, 8, 12, and at baseline of the screening period.
Patients reported outcomes were assessed at week 12 among patients with a baseline score of at least 4 points as a decrease from baseline of at least 4 points in the Peak Pruritus Numeric Rating Scale (PP-NRS) score assessed on an 11-point scale, with 0 indicating “no itch” and 10 being considered as the “worst imaginable itch”.
The primary end point of the phase 3 trials study was a PGA score of 0 (clear) or 1 (almost clear) and a decrease from baseline of at least 2 points at week 12. Secondary efficacy end points at week 12 were a reduction of at least 75% in the Psoriasis Area and Severity Index (PASI) score, a PGA score of 0 or 1, the mean change from baseline in the percent of body-surface area affected, and a reduction of at least 90% in the PASI score.
According to the data, PGA response occurred in 35.4% of the patients in the tapinarof group and in 6% of those in the vehicle group in trial 1.
Additionally, a PGA response was recorded in 40.2% of the tapinarof group and 6.3% of the vehicle group in trial 2 (P<0.001 for both comparisons).
Lebwohl and colleagues added that results for secondary endpoints and patient-reported outcomes were generally similar as those recorded for the primary endpoint.
Adverse events with tapinarof cream were folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus, which investigators believed warranted further studies.
“Larger and longer trials are needed to evaluate the efficacy and safety of tapinarof cream as compared with existing treatments for psoriasis,” the team wrote.
The study, “Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis,” was published online in the New England Journal of Medicine.