Tapinarof nonsteroidal anti-inflammatory topical cream, applied once or twice daily, showed efficacy in treating mild-to-moderate plaque psoriasis, according to late-breaking research presented at the American Academy of Dermatology Annual Meeting in Orlando, Florida.
Tomoko Maeda-Chubachi, MD, presented research on a randomized, evaluator-blinded study of 227 adults with psoriasis; about 80% of patients had mild-to-moderate plaque-type psoriasis. The study included a screening, 12 weeks of treatment with tapinarof topical cream (GSK2894512, GlaxoSmithKline). Tapinarof is as synthetic hydroxylated stilbene molecule that acts as an anti-inflammatory agent. No novel nonsteroidal topical therapies for psoriasis have been approved in more than 25 years, according to the researchers, with current topical options limited to corticosteroids or vitamin D analogs.
The primary endpoint was proportion of patients with physician global assessment (PGA) score of 0 or 1 (clear or almost clear) at week 12, with a minimum 2-grade improvement in 5-point PGA score from baseline to week 12. The secondary endpoint was proportion of patients achieving a 75% improvement in Psoriasis and Severity Index (PASI 75) score.
Patients were treated with 1% tapinarof cream once or twice daily, 0.5% tapinarof cream once or twice daily or vehicle once or twice daily.
There were 174 patients who completed the study.
The researchers found that 65% and 56% of patients in the twice-daily and once-daily tapinarof 1% groups, respectively, achieved the primary endpoint, as did 46% and 36% of patients in the twice-daily and once-daily tapinarof 0.5% groups, respectively. Among vehicle patients, 11% and 5% of the twice-daily and once-daily patients, respectively, reached the primary endpoint.
PASI 75 results were achieved by 65% and 56% of patients in the tapinarof 1% twice-daily and once-daily groups, respectively, and by 46% of patients in both the once-daily and twice-daily tapinarof 0.5% groups. In the vehicle group, 16% of the twice-daily group and 5% of the once-daily group achieved PASI 75.
Four weeks after discontinuation, efficacy was maintained.
Ten percent of patients in the tapinarof treatment groups and 1% of the vehicle treatment groups discontinued the study due to adverse events, with contact dermatitis being the most common adverse event leading to drug discontinuation.
Maeda-Chubachi and colleagues concluded that the 1% cream demonstrated higher efficacy than the 0.5% cream, and the 1% had quicker onset of action, with no difference between once- or twice-daily applications.
“Tapinarof cream 0.5% and 1% [once-daily] or [twice-daily] showed efficacy for plaque psoriasis in this study … [and] is generally safe and well tolerated,” Maeda-Chubachi concluded. “Tapinarof cream could be an improved treatment option over existing therapy.” – by Bruce Thiel
Maeda-Chubachi T. F056 – Late-breaking Research Forum Clinical Trials. Presented at: American Academy of Dermatology Annual Meeting; March 3-7, Orlando.
Disclosure: Maeda-Chubachi reports being an employee of Glaxo-Smith-Kline, which sponsored the study.