Following promising results from the use of roflumilast 0.3% cream in phase 2b trials, researchers conducted 2 phase 3 trials, DERMIS-1 and DERMIS-2, to further define the efficacy of roflumilast in patients with plaque psoriasis. In their study, published in JAMA, the authors concluded that roflumilast induced more favorable 8-week outcomes compared with vehicle control.

The DERMIS-1 and DERMIS-2 trials were performed from December 9, 2019, to November 16, 2020, and December 9, 2019, to November 23, 2020, respectively. DERMIS-1 included 439 patients from 40 centers across the United States and Canada, and DERMIS-2 included 442 patients from 39 centers across those same regions. Eligible patients were aged 2 years or older and had plaque psoriasis involving 2% to 20% of body surface area. The final follow-up dates were November 20, 2020, and November 23, 2020, for DERMIS-1 and DERMIS-2, respectively.

The primary end point of the trials was treatment success according to improvement from baseline Investigator Global Assessment (IGA) score at week 8. Secondary end points included treatment successes in intertriginous sites, 75% reductions in Psoriasis Area and Severity Index score, and 4-point reductions in the Worst Itch Numeric Rating Scale.

According to the authors, a significantly higher proportion of patients treated with roflumilast achieved IGA success at week 8 compared with vehicle recipients (DERMIS-1, 42.4% vs 6.1%; 95% CI, 32.3-46.9; DERMIS-2, 37.5% vs 6.9%; 95% CI, 20.8-36.9; both P<.001). Furthermore, 8 of 9 and 9 of 9 secondary end points favored roflumilast in DERMIS-1 and DERMIS-2, respectively.

The researchers concluded that treatment with roflumilast 0.3% cream is an effective treatment option for patients with chronic plaque psoriasis. They also acknowledged that more studies are needed to evaluate long-term characteristics and compare efficacy with other treatments.

Reference: Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632

Link: https://jamanetwork.com/journals/jama/article-abstract/2796379