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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 37.6% 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, where to buy generic zofran online no prescription 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 complete disease clearance regardless of their starting store, 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.

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