Enstilar泡沫剂治疗斑块型银屑病的效果能维持多久？

The effect of Enstilar foam in treating plaque psoriasis can last for 52 weeks or even more than 52 weeks. PSO-LONG results show that long-term, twice-weekly Enstilar foam treatment can help patients maintain skin lesions that are clear or nearly completely clear for up to 52 weeks.

About Enstilar Foam

Is a topical medication used to treat plaque psoriasis that contains calcipotriol (a vitamin D analog) and betamethasone dipropionate (a corticosteroid). This combination preparation has been approved in the United States for the treatment of plaque psoriasis in patients 12 years and older.

Duration of efficacy of Enstilar Foam in the treatment of plaque psoriasis

PSO-LONG is a Phase 3 clinical trial evaluating the efficacy and safety of Enstilar Foam, once daily for the first 4 weeks, in the long-term treatment (up to 52 weeks) of adults with plaque psoriasis. In this study, patients were randomly assigned to receive Enstilar foam or placebo foam twice weekly for up to 52 weeks.

The study results showed that at week 52, 92.5% and 92.4% of patients receiving active and reactive Cal/BD foam maintained BSA ≤ 3, and Enstilar foam was able to maintain its therapeutic effect and had a good safety profile. A fixed-dose combination of betamethasone dipropionate (BD) and calcipotriol (Cal) foam twice weekly for 52 weeks (active treatment) reduced the risk of relapse.

Enstilar Foam for the Treatment of Plaque Psoriasis

Research Background

Topical psoriasis treatment relies on a reactive approach rather than a long-term approach to preventing disease recurrence.

Research purpose

To evaluate the long-term efficacy and safety of twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% Enstilar foam in the treatment of psoriasis.

Research Methods

In a Phase III trial, there was a 4-week open-label run-in period and a 52-week randomized double-blind maintenance period. A total of 545 patients achieved treatment success, defined as a physician's global assessment of "clear" or "almost clear," ≥2 grade improvement from baseline, and were randomly assigned to active management (n=272) or reactive management (n=273) twice weekly, with rescue therapy with Cal/BD foam once daily for 4 weeks after relapse.

Results

A total of 251 randomized patients completed the trial, and the median time to first relapse was 56 days and 30 days. Over a year, patients in the active treatment group experienced 41 more days of remission than those in the passive treatment group. The number of relapses per year of exposure was 3.1 and 4.8.

In a randomized, multicenter trial, treatment with calcipotriol/betamethasone dipropionate foam for 4 weeks resulted in treatment success in a greater proportion of patients than treatment with a fixed-dose combination of calcipotriol/betamethasone dipropionate for 4 weeks as a foam vehicle, as individual components of a foam, or as an ointment, or for 8 weeks with a fixed-dose combination as a topical suspension.

Treatment with calcipotriol/betamethasone dipropionate foam resulted in significantly lower Modified Psoriasis Area and Severity Index scores and greater improvements in itch-related sleep loss and health-related quality of life from baseline to week 4 at assessments compared with the comparison group.

Usage and dosage

Enstilar foam needs to be shaken before use, and then applied to the affected area once a day for 4 weeks. Treatment should be stopped in time after symptoms are controlled. Do not use more than 60g every 4 days.

Summary

As a foam formulation, Enstilar is more convenient to use than traditional ointments, creams or gels. It is especially suitable for patients with large psoriasis lesions. It can save application time and may improve patients' treatment compliance.

References:

Lebwohl M, Kircik L, Lacour JP, Liljedahl M, Lynde C, Mørch MH, Papp KA, Perrot JL, Gold LS, Takhar A, Thaçi D, Warren RB, Wollenberg A. Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial). J Am Acad Dermatol. 2021 May;84(5):1269-1277. doi: 10.1016/j.jaad.2020.09.037. Epub 2020 Sep 18. PMID: 32950546.

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