Psoriasis Cream Succeeds in Early Trial- NEJM
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Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.

In this phase 2b, double-blind trial, researchers randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream once daily for 12 weeks. The primary efficacy outcome was the investigator’s global assessment (IGA) of a status of clear or almost clear at week 6. 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.

Results:
-- Among 331 patients, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream.
-- 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 vehicle group.
-- Among the approximately 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 group, 44% in the roflumilast group, and 29% of those in the vehicle group.
-- The mean baseline PASI scores were 7.7 in the roflumilast group, 8.0 in the roflumilast group, and 7.6 in the vehicle group; the mean change from baseline at week 6 was -50.0%, -49.0%, and -17.8%, respectively.
-- Application-site reactions occurred with similar frequency in the roflumilast groups and the vehicle group.

Conclusively, 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 6 weeks. Longer and larger trials are needed to determine the durability and safety of roflumilast in psoriasis.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2000073
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Dr. U●●●s B●●●●●●●r
Dr. U●●●s B●●●●●●●r Internal Medicine
Good information
Jul 17, 2020Like