Proactive Management with Twice-Weekly Topical Cal/BD Foam Prolongs Treatment Efficacy Versus Reactive Management in Patients with Plaque Psoriasis

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Keywords

adult, area under the curve, comparative effectiveness, conference abstract, controlled study, double blind procedure, drug withdrawal, female, foam, follow up, human, learning, maintenance therapy, major clinical study, male, psoriasis vulgaris, randomized controlled trial, relapse, remission, topical drug administration

Abstract

Introduction: The PSO-LONG study showed that long-term proactive management with calcipotriol 50 μg/g/betamethasone dipropionate 0.5 mg/g (Cal/BD) foam was superior versus reactive management in patients with plaque psoriasis. This sub-analysis of PSO-LONG assessed the efficacy of four weeks daily treatment with Cal/BD foam and compared the sustained efficacy of proactive versus reactive management for up to 52 weeks Methods, Results: Following the initial four-week open-label lead-in phase (Cal/BD foam once daily [QD]), patients entered a 52-week randomised, double-blind maintenance phase and 8-week follow-up period. At maintenance phase entry, patients were randomised to proactive (continued Cal/BD foam) or reactive (vehicle foam) treatment twice weekly. Rescue treatment of Cal/BD QD for four weeks was given to patients experiencing a relapse (PGA ≥2), in either treatment group. If PGA was <2 after 4 weeks, maintenance therapy resumed, otherwise the patient was withdrawn if PGA was ≥2. mPASI and PGA scores were evaluated up to 52 weeks. In the 4-week open-label lead-in phase, 80% of patients (n = 521) achieved treatment success with significant improvements in mPASI and PGA scores (both P < 0.0001). After 4 weeks of the maintenance phase, a clear separation in mean PGA scores was observed, which was maintained throughout the study. The area under the curve (AUC) distribution for mean PGA score was 15% lower for proactive versus reactive therapy throughout the maintenance phase (1.35 versus 1.59; P = 0.0001) and was 20% lower for mean mPASI score (2.27 versus 2.84; P = 0.0005). The number of symptom-free days defined as PGA 0/1, mPASI 90, mPASI 75 or mPASI ≤3, was significantly higher with proactive versus reactive therapy (all P < 0.001). Conclusions: Proactive management of adult psoriasis patients with twice-weekly Cal/BD foam for up to 52 weeks was associated with sustained and significantly lower mean mPASI/PGA scores, and significantly more days in remission versus reactive management. Learning Objective To report the efficacy of four weeks of daily Cal/BD foam in the open-label lead-in phase of the PSO-LONG study To assess the sustained efficacy of proactive versus reactive management during the 52-week double-blind maintenance phase To compare the number of days in sustained remission between proactive and reactive management strategies Takeaway Message The efficacy of four weeks of daily treatment with Cal/BD foam is sustained when patients are transitioned to a proactive twice weekly maintenance regimen for up to 52 weeks.

Volume

25

Issue

1 SUPPL

First Page

66S

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