Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials

August 2021 | Volume 20 | Issue 8 | Original Article | 822 | Copyright © August 2021


Published online July 30, 2021

Karen A. Veverka a, Jes B. Hansen a, Maria Yaloumis a, Leon Kircik MDb, Linda Stein Gold MDc

aLEO Pharma, Madison, NJ
bIcahn School of Medicine at Mount Sinai, NY; Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC, Louisville, KY
cHenry Ford Hospital, Detroit, MI

Abstract
Background: Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited.
Objective: To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis.
Methods: Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA BSA score.
Results: Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA BSA score.
Limitations: These post hoc analyses need to be confirmed with prospective studies.
Conclusion: Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease.
Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938

J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743

INTRODUCTION

Psoriasis is a lifelong, relapsing, immune-mediated disease that affects the skin and is present in an estimated 125 million people worldwide.1-5 Plaque psoriasis manifests as sharply demarcated, scaling, and erythematous lesions that can be painful and severely pruritic.2,6,7 The strong psychological impact of this disease can substantially decrease a patient’s quality of life.2,7,8

Because there is no cure for psoriasis, treatment strategies aim to clear active disease sites and prolong symptom-free periods.9 Topical vitamin D analogs (eg, calcipotriene) and corticosteroids (eg, betamethasone) are cornerstones of treatment for patients with mild to moderate psoriasis.9-13 Calcipotriene and betamethasone dipropionate (Cal/BD) foam is a fixed combination of calcipotriene at 50 mcg/g and betamethasone dipropionate at 0.64 mg/g. Cal/BD foam is an FDA-approved treatment for plaque psoriasis in patients 12 years of age and older.10 The efficacy of Cal/BD foam has previously been demonstrated in a population of patients with disease ranging from mild to severe disease in 1 Phase 2 trial and in 2 Phase 3 trials.11,14,15

Although most patients (~80%) have mild-to-moderate disease,12 an overwhelming number of studies are performed in populations with moderate-to-severe psoriasis.16 The skewing of study samples toward moderate-to-severe psoriasis populations may partly be a consequence of the tools that are used in clinical trials. For example, for the Investigator’s Global Assessment (IGA) of disease severity, treatment success is defined as a score of “clear" (IGA=0) or “almost clear” (IGA=1) for patients with moderate-to-severe disease, but patients with mild disease are required to be fully clear of visible disease (IGA=0).11 Thus, patients with moderate (IGA=3) or severe (IGA=4) baseline IGA scores have less stringent requirements and more potential to achieve an IGA score that is sufficiently reduced to fulfill criteria for treatment success. In contrast, patients with mild baseline disease (IGA=2) have less room for improvement and are required to be completely clear