Experimental Cream Improves Plaque Psoriasis but Can Spark Local Side Effects, Headaches

By Reuters Staff

December 09, 2021

NEW YORK (Reuters Health) - A cream containing Dermavant Sciences' experimental drug tapinarof significantly improves plaque psoriasis in about a third of patients, but it may also spark headaches and other side effects such as folliculitis and contact dermatitis, according to results of two phase-3 trials.

The once-daily topical aryl-hydrocarbon-receptor-modulating agent is currently being evaluated by the U.S. Food and Drug Administration with a decision expected in the second quarter of next year.

Among 1,025 adult volunteers with mild-to-severe disease and 3% to 20% of their skin affected, 12 weeks of daily therapy produced a significant improvement in 37.8% of the patients, as judged by a decrease of at least two points on a 0-4 scale, where 2 represents mild disease, 3 indicates moderate disease and a 4 is the most severe disease.

By comparison, only 6.1% of the people given the same cream but without tapinarof showed the same degree of improvement, researchers report in the New England Journal of Medicine.

About 80% of the volunteers, all from the United States and Canada, started the trial with a score of 3.

Attempts to gather quality of life data were hampered by the COVID-19 pandemic.

"Unfortunately, no clear conclusions can be drawn with respect to patient-reported outcomes such as itching and quality of life, which are important aspects of interest for patients and physicians and particularly for third-party payers," said Dr. Thomas Bieber of the University Hospital Bonn, Germany, in a linked editorial.

Plaque psoriasis affects 80% to 90% of the estimated 125 million people worldwide with psoriasis, about 8 million of whom are in the United States.

Of all 683 patients randomly assigned to receive tapinarof in the two identical trials, 141 (or 20.1%) developed folliculitis, leading to treatment discontinuation in nine (1.3%). The rate of folliculitis was 0.9% with vehicle cream.

Contact dermatitis occurred in 5.4% of tapinarof recipients (37 patients) versus just one patient in the control group. The problem led to discontinuation of the therapy in 12 people (1.8%).

Headache occurred in 26 patients in the tapinarof group (3.8%) versus five in the control group (1.5%). Only three patients discontinued the treatment because of that side effect.

The results, combined from two studies known as PSOARING 1 AND 2, were originally released by Dermavant Sciences in August of 2020.

On September 30, the company released results from its PSOARING 3 open-label extension study, which found that after 40 additional weeks of treatment, 58% of the 519 volunteers who started with a score of 2 or higher achieved a score of 0 or 1. The company said that result demonstrated the drug's "continued improvement in efficacy beyond the 12-week pivotal studies."

Overall, 41% achieved a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) regardless of their starting score, according to Dermavant, which paid for the studies.

SOURCE: https://bit.ly/3poYUQ9 and https://bit.ly/3EryMu3 The New England Journal of Medicine, online December 8, 2021.