Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication

August 2020 | Volume 19 | Issue 8 | Original Article | 723 | Copyright © August 2020


Published online July 31, 2020

Leon Kircik , Linda Stein Gold , Joyce Teng , Angela Moore , Wendy Cantrell , Javier Alonso-Llamazares , John Koo

aIcahn School of Medicine at Mount Sinai, New York, NY bHenry Ford Health System, Detroit, MI cStanford University Department of Dermatology, Palo Alto, CA dArlington Research Center, Arlington, TX and Baylor University Medical Center, Dallas, TX eVillage Dermatology, Mountain Brook, AL fDepartment of Dermatology, VA Medical Center, Miami, FL gDepartment of Dermatology, University of San Francisco, San Francisco, CA

Abstract
Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided.

J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300

INTRODUCTION

Psoriasis is a chronic, inflammatory condition characterized by the formation of erythematous, scaly plaques in various regions of the body.1,2 Treatment strategies are typically guided by assessments of disease severity, with topical agents generally used to treat mild-to-moderate disease and photo-, oral and biologic therapies reserved for moderate-to-severe disease.1,3,4 Prior to initiating biologic therapy, quality-of-life (QOL) assessments and discussions with the patient about treatment costs are also recommended.1 The recent development of novel topical medications has expanded the strategies that can be considered for managing patients with greater disease severity.5,6 Given the complex nature of managing moderate-to-severe psoriasis, the availability of an efficacious, safe, easy-to-use, topical medication has the potential to improve treatment outcomes,5 adherence,7 and patient satisfaction8 to deliver cost savings.9

Calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) foam (Cal/BD; Enstilar®) is an FDA-approved, once-daily topical agent indicated for the treatment of plaque psoriasis in patients 12 years and older.10 The proprietary aerosol foam formulation enables supersaturation of Cal/BD that greatly enhances skin penetration and bioavailability.11 While nominally a foam, the product is administered as an aerosol spray,10 which can be applied to relatively large areas with ease. In pivotal Phase 2 and 3 trials, Cal/BD foam showed superior efficacy, together with favorable safety profiles, in comparisons with Cal/BD topical suspension (Taclonex® Topical Suspension; formulated as a gel), Cal/BD ointment (Taclonex® Ointment), Cal foam and BD foam, and foam vehicle.12-15 Patients with psoriasis ranging from mild to severe, as defined by the Physician’s Global Assessment (PGA) scale, were eligible for these studies; however, the majority (>70%) had moderate disease (PGA=3), and approximately 10% had severe disease (PGA=4).12-15 This patient distribution differs from that of many other psoriasis clinical trials conducted in moderate-to-severe patients, in which baseline populations were weighted to more severe disease.16 Therefore, we differentiate these patients in Cal/BD foam trials with baseline severity greater than mild as having “beyond-mild” psoriasis. Several post hoc analyses and small-scale studies have shown that beyond-mild psoriasis patients can benefit from treatment with Cal/BD foam, either alone or as adjunctive therapy.5,17-20