Disclosures: Lebwohl reports he receives grant support from Ortho Dermatologics, UCB, AbbVie, Amgen, Eli Lilly, Incyte and Janssen Research and Development; grant support and consulting fees from Pfizer, Dermavant Sciences, Leo Pharma, Boehringer Ingelheim and Arcutis Biotherapeutics; and consulting fees from Allergan, Almirall, Avotres Therapeutics, BirchBioMed, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, EMD Serono, Evelo Biosciences, Inozyme Pharma, Meiji Seika Pharma, Menlo Therapeutics, Mitsubishi Pharma, NeuroDerm, Promius Pharma-Dr. Reddy’s Laboratories, Theravance Biopharma, Verrica Pharmaceuticals, Aditum Bio, BMD Skincare and Kyowa Kirin. Please see the study for all other authors’ relevant financial disclosures.
July 20, 2020
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Roflumilast cream superior to vehicle in treatment of plaque psoriasis

Disclosures: Lebwohl reports he receives grant support from Ortho Dermatologics, UCB, AbbVie, Amgen, Eli Lilly, Incyte and Janssen Research and Development; grant support and consulting fees from Pfizer, Dermavant Sciences, Leo Pharma, Boehringer Ingelheim and Arcutis Biotherapeutics; and consulting fees from Allergan, Almirall, Avotres Therapeutics, BirchBioMed, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, EMD Serono, Evelo Biosciences, Inozyme Pharma, Meiji Seika Pharma, Menlo Therapeutics, Mitsubishi Pharma, NeuroDerm, Promius Pharma-Dr. Reddy’s Laboratories, Theravance Biopharma, Verrica Pharmaceuticals, Aditum Bio, BMD Skincare and Kyowa Kirin. Please see the study for all other authors’ relevant financial disclosures.
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Roflumilast cream was superior to vehicle cream in attaining Investigator’s Global Assessment status of clear or almost clear at 6 weeks in patients with plaque psoriasis, according to a study in The New England Journal of Medicine.

“The topical PDE-4 inhibitor roflumilast, a once-daily cream consisting of roflumilast in a high-water-content moisturizing cream base vehicle containing the cosmetic solvent ethoxydiglycol, is being investigated for the treatment of plaque psoriasis,” Mark G. Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote. “In this phase 2b trial, we evaluated the efficacy and safety of two dose levels of roflumilast cream, administered daily over a period of 12 weeks, for the treatment of plaque psoriasis.”

In a double-blind trial, 331 patients with plaque psoriasis were assigned to randomly receive roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle cream once daily for 12 weeks. Study assessments included Investigator’s Global Assessment status of clear or almost clear at week 6, decrease in Psoriasis Area and Severity Index score as well as evaluation of adverse events.

IGA score was clear or almost clear at week 6 in 28% of patients in the roflumilast 0.3% group, 23% of patients in the roflumilast 0.15% group and 8% of patients in the vehicle group (P < .001 and P = .004 vs. vehicle for roflumilast 0.3% and 0.15%, respectively); IGA status of clear or almost clear continued through week 12 in 38% of patients, 32% of patients and 16% of patients in the respective groups.

Mean change in PASI score at week 6 was –50% in the roflumilast 0.3% group, –49% in the roflumilast 0.15% group and –17.8% in the vehicle group.

Application site reactions occurred in both roflumilast groups and the vehicle group, with local irritation as the main reported event.

“This phase 2b trial of roflumilast cream showed greater reductions in psoriasis signs and symptoms than placebo vehicle cream at 6 weeks,” Lebwohl and colleagues wrote. “Longer and larger trials are necessary to determine the effectiveness and safety of roflumilast.”