HealthDay News – Roflumilast cream is superior to placebo vehicle cream for reducing psoriasis severity, according to a study published in the July 16 issue of the New England Journal of Medicine.
Mark G. Lebwohl, MD, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a phase 2b, double-blind trial in which adults with plaque psoriasis were randomly assigned to use either roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) once daily for 12 weeks (109, 113, and 109 patients, respectively).
The researchers found that 28, 23, and 8% of patients in the roflumilast 0.3%, roflumilast 0.15%, and placebo groups had an investigator’s global assessment (IGA) score indicating clear or almost clear at week 6, respectively. An IGA score indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73, 44, and 29 percent of those in the roflumilast 0.3%, roflumilast 0.15%, and placebo groups, respectively. The mean baseline Psoriasis Area and Severity Index scores were 7.7, 8.0, and 7.6, respectively; the corresponding mean change from baseline to week 6 was −50.0%, −49.0%, and −17.8%.
“We found that roflumilast cream was efficacious in reducing the severity of psoriasis according to an investigator assessment of a state of clear or almost clear of plaque psoriasis,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Arcutis Biotherapeutics, which developed roflumilast and funded the study.