The Effect on BSA of Proactive Management versus Reactive Management of Psoriasis With Fixed-Dose Cal/BD Foam in the PSO-LONG Study

May 2021 | Volume 20 | Issue 5 | Features | 567 | Copyright © May 2021


Published online April 30, 2021

doi:10.36849/JDD.5870

Amrit Takhar MBChB MRCGP,a Henrik Thoning PhD,b Nanna Nyholm MSc,b Bibi Petersen MD,b Linda Stein Gold MDc

aWansford and Kings Cliffe Practice, Wansford, Cambridgeshire, UK
bLEO Pharma, Ballerup, Denmark
cDepartment of Dermatology, Henry Ford Hospital, Detroit, MI

Abstract
Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed.

Analyses found that after the PSO-LONG study’s four-week open-label lead-in phase, when all patients received once-daily Cal/BD foam, mean BSA was significantly reduced. Thereafter, mean BSA remained at lower levels in patients on proactive management compared to reactive management. This was reflected in AUC BSA, which was consistently lower in the proactive management arm. Treatment-related differences were statistically significant when analyzing the full analysis set (FAS) population, as well as when restricting the analysis to study completers.

Additional analyses restricted the dataset to include only observations from psoriasis remission periods, or periods of disease relapse. Treatment-related differences in AUC were statistically significant in observations during remission, but not during relapse. This could be expected given the trial’s design, wherein all patients who relapsed were offered the same rescue therapy with once daily Cal/BD foam. Similarly, for patients who dropped out, there was no treatment-related difference in mean BSA during the two weeks preceding dropout, likely due to the common occurrence of relapse in these patients. This paper found that proactive management, in addition to preventing more relapses as previously shown, also maintained BSA at a lower level during remission than reactive management.

J Drugs Dermatol. 20(5):567-570. doi:10.36849/JDD.5870

INTRODUCTION

Arecent Phase III clinical study (PSO-LONG, NCT02899962) assessed the benefit of proactive management of psoriasis using twice-weekly calcipotriene/betamethasone dipropionate (Cal/BD) foam in patients successfully treated with once-daily Cal/BD foam. Patients who achieved treatment success, defined as Physician’s Global Assessment (PGA) ‘clear’ or ‘almost clear’ scores, and a ≥2 grade improvement from baseline during an open-label phase of four weeks were randomized to ‘proactive’ management (Cal/BD foam twice weekly; n=256) or ‘reactive’ management (vehicle foam twice weekly; n=265) in the maintenance phase lasting 52 weeks. In both arms, a relapse (PGA ≥2) was treated with rescue treatment of Cal/BD foam given once daily for four weeks.1

The primary endpoint of PSO-LONG was time to first relapse and the secondary endpoints were time in remission and number of relapses, which are the focus of the main study publication.1 Reduction of body surface area (BSA) affected by psoriasis is a clinically meaningful endpoint and is associated with improvement in quality of life for psoriasis patients.2,3 This paper focuses on a post-hoc analysis of BSA from PSO-LONG.

AIMS AND OBJECTIVES

The impact of initiation of treatment with Cal/BD foam once daily for four weeks, and of proactive and reactive management in the maintenance phase on mean BSA was assessed. Additionally, the normalized area under the curve (AUC) was calculated for the two arms in the maintenance phase for the total population and for different disease status. Finally, the analysis assessed mean BSA at dropout and the difference across the two treatment arms.
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