Treatment with roflumilast cream results in better clinical status at eight weeks versus vehicle cream among patients with chronic plaque psoriasis, according to a study published in the Sept. 20 issue of the Journal of the American Medical Association.

Mark G. Lebwohl, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues examined the efficacy of roflumilast cream, 0.3 percent, applied once daily for eight weeks in two multicenter trials involving patients with plaque psoriasis (DERMIS-1, 439 patients; DERMIS-2, 442 patients). Patients were randomly assigned to receive roflumilast cream or vehicle cream (trial 1, 286 and 153 patients, respectively; trial 2, 290 and 152 patients, respectively).

The researchers found that the mean Investigator Global Assessment (IGA) scores were all 2.9 for roflumilast and vehicle in both trials 1 and 2. Significantly greater percentages of roflumilast- versus vehicle-treated patients had IGA success at week 8 in both trials (trial 1: 42.4 versus 6.1 percent; trial 2: 37.5 versus 6.9 percent). Significant differences were seen favoring roflumilast in eight and nine of nine secondary end points in trials 1 and 2, respectively, including intertriginous IGA success, 75 percent reduction in the Psoriasis Area and Severity Index score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction.

"Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety," the authors write.

Several authors disclosed financial ties to biopharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.

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