罗氟司特乳膏能根治银屑病吗

Roflumilast cream does not cure psoriasis. Roflumilast cream has shown long-term efficacy in the treatment of plaque psoriasis in patients over 12 years of age, with a median duration of response of up to 10 months. Roflumilast cream is the first PDE-4 inhibitor for plaque psoriasis indications. It does not contain hormones and is a selective non-steroidal PDE-4 inhibitor that will not cause dependence in humans. Patients can apply it externally once a day for continuous and long-term use, and can be used on special areas such as the face, armpits, groin, etc., with no limit on the time of use.

Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [NCT04211363, Trial 1; n = 439] and DERMIS-2 [NCT04211389, Trial 2; n = 442]) were conducted at 40 centers (Trial 1) and 39 centers (Trial 2) in the United States and Canada, respectively. Plaque psoriasis affects 2 to 20 percent of the body surface area in people 2 years of age or older.

Patients were randomized 2:1 to receive 0.3% roflumilast cream (Trial 1: n = 286; Trial 2: n = 290) or vehicle cream (Trial 1: n = 153; Trial 2: n = 152) once daily for 8 weeks.

Results: Among 881 participants, the mean IGA (global assessment) score for roflumilast cream in trial 1 was 2.9 [SD, 0.52] and the mean IGA score for vehicle was 2.9 [SD, 0.45], and the mean IGA score for roflumilast cream in trial 2 was 2.9% [SD, 0.48] and the mean IGA score for vehicle was 2.9 [SD, 0.47].

At week 8, roflumilast cream-treated patients had significantly higher IGA success rates than vehicle-treated patients (Trial 1: 42.4% vs 6.1%; difference 39.6%; Trial 2: 37.5% vs 6.9%; difference 28.9%.

Statistically significant differences in favor of roflumilast cream versus vehicle were observed in 8 of 9 secondary endpoints in Trial 1 and 9 in Trial 2, including primary IGA success rate (71.2% vs 13.8% and 68.1% vs 18.5%), 75% reduction in PASI score (41.6% vs 7.6%; differences 36.1% and 39.0% vs vehicle 5.3%; difference 32.4%), WI-NRS success rate (67.5% vs 26.8%; difference 42.6% and 69.4% vs 35.6%; difference 30.2%).

Conclusions: In patients with chronic plaque psoriasis, treatment with roflumilast 0.3% cream for 8 weeks resulted in better clinical outcomes compared with vehicle cream.

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References

Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632. PMID: 36125472; PMCID: PMC9490499.