New York—Options for psoriasis treatment have been greatly expanded with the availability of systemic oral phosphodiesterase type 4 (PDE-4) inhibitors.

Now, a report in the New England Journal of Medicine reports on a phase llb, double-blind trial of roflumilast cream that contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.

For the study, Icahn School of Medicine at Mount Sinai–led researchers randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or placebo cream once daily for 12 weeks. Among 331 patients who underwent randomization, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to the placebo.

Defined as the primary efficacy outcome was the investigator’s global assessment (IGA) of a status of clear or almost clear at week 6. Patients were assessed on a 5-point scale of plaque thickening, scaling, and erythema, with a score of 0 indicating clear, 1 almost clear, and 4 severe.

Researchers note that secondary outcomes included an IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score (range, 0 to 72, with higher scores indicating worse disease). The trial also assessed safety.

According to the results of the industry-funded trial, an IGA score indicating clear or almost clear at week 6 was observed in 28% of the patients in the roflumilast 0.3% group, in 23% in the roflumilast 0.15% group, and in 8% in the placebo group (P <.001 and P = .004 versus placebo for roflumilast 0.3% and 0.15%, respectively).

In addition, researchers report that, among the about 15% of patients overall who had baseline intertriginous psoriasis of at least mild severity, an IGA score at week 6 indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73% of the patients in the roflumilast 0.3% group, 44% of those in the roflumilast 0.15% group, and 29% of those in the vehicle group.

The mean baseline PASI scores were 7.7 in the roflumilast 0.3% group, 8.0 in the roflumilast 0.15% group, and 7.6 in the placebo group, with the mean change from baseline at week 6 calculated at −50.0%, −49.0%, and −17.8%, respectively. 

The authors note that application-site reactions occurred with similar frequency in the roflumilast groups and the placebo groups.

“Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at six weeks,” the researchers conclude. “Longer and larger trials are needed to determine the durability and safety of roflumilast in psoriasis.”

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