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Roflumilast Cream for Chronic Plaque Psoriasis

Patients with chronic plaque psoriasis had better outcomes when treated with roflumilast cream compared with vehicle cream, the DERMIS I and II trials conclude. The phase 3 randomized clinical trials of this potent phosphodiesterase 4 inhibitor included a combined 881 participants. Investigator Global Assessment success at 8 weeks in the group treated with roflumilast cream vs vehicle cream was 42.4% vs 6.1% in 1 trial and 37.5% vs 6.9% in the other trial. Both differences were statistically significant.

Treatment-emergent adverse events occurred in similar percentages of study participants: 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2.

Editorial: “Based on [these clinical trials], roflumilast cream is a promising addition to the psoriasis armamentarium, potentially filling an important treatment gap,” writes an editorialist. “As adherence to topical therapy is often low, the moisturizing cream vehicle of roflumilast has advantages and once-daily application is convenient. Given the availability of safe, effective, affordable, and well-tolerated topical treatments for psoriasis, the ultimate utility of roflumilast cream will be determined by cost and clinical effectiveness in nontrial settings. While vehicle-controlled trials have value in determining the efficacy and safety of active drugs, clinical trials that compare new topical drugs to active therapies are needed. Future studies should also include diverse populations. Nonetheless, the addition of a drug with a relatively new mechanism to the topical treatment options for psoriasis is an exciting development and may facilitate discovery of other novel therapies.”

Source: JAMA