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
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
