Treating Scalp Psoriasis With Fixed-dose Combination Calcipotriene/Betamethasone Dipropionate Cutaneous Foam: Review of Phase 2 Data

August 2020 | Volume 19 | Issue 8 | Original Article | 785 | Copyright © August 2020


Published online July 16, 2020

doi:10.36849/JDD.2020.5168

Bibi Petersen MD PhD,a Mark Lebwohl MDb

aLEO Pharma A/S, Ballerup, Denmark bDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

Abstract
Two Phase 2 studies investigated the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in adult and adolescent patients. Patients had psoriasis classified as at least ‘mild’ per PGA. NCT01536938 enrolled adult patients (≥18 years) randomized 1:1:1 to once-daily (QD) Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%) or BD foam (0.064%). NCT02387853 enrolled adolescent patients (12– <17 years) to Cal/BD foam QD (dose as previously). Treatment success was based on improvement in PGA classification at week 4. Additional efficacy endpoints included mPASI in adults and effect on extent of scalp surface area (SSA) in adolescents. Safety was also assessed. Overall, 302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment. Treatment success in adults was significantly higher with Cal/BD vs Cal foam (53.0% vs 35.6%, P=0.021) and numerically higher than with BD foam (47.5%, P=0.45). Mean percentage changes in mPASI were –80.0%, –57.8% and –71.2%, for Cal/BD, Cal and BD foam, respectively. In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean SSA fell from 50.6% at baseline to 12.5% at week 4. All treatment-related AEs were considered mild-to-moderate across both studies, except one severe AE (hypersensitivity reaction with urticaria) in the adult Cal/BD foam group, which led to withdrawal from the study. In these studies, treatment of scalp psoriasis with Cal/BD foam provided good efficacy for adults and adolescents and was generally well tolerated.

J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5168

INTRODUCTION

Psoriasis is a chronic, immune-mediated, inflammatory condition affecting mainly the skin and joints, with a prevalence of approximately 2%.1 Data suggest that the scalp is affected in up to 79% of patients with psoriasis2 and that this frequency increases with duration of the disease.3 Scalp psoriasis can cause impairment of hair growth, potentially resulting in scarring and alopecia,4 and is associated with considerable psychological and social distress in a majority of patients, with itch and scaling the most frequent and distressing symptoms.2,5 Approximately 80% of psoriasis patients have mild-to-moderate disease which, in the majority of cases, is treated topically; the scalp is considered a difficult-to-treat area.1,5,6 Standard first-line topical interventions are topical corticosteroids, often combined with vitamin D3 analogues.5 Skin atrophy, a well-known side effect of steroid treatment, is rarely observed in the scalp, possibly because of its dense vascularization and abundance of adnexal structures.7

Relatively few published studies have evaluated the use of topical treatments in scalp psoriasis. Here we report the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in patients enrolled in two multicentre Phase 2 studies. Positive efficacy results on body psoriasis from these patients have already been published.8,9

METHODS

Both Phase 2 studies enrolled patients with psoriasis vulgaris of the body and scalp classified as at least mild according to the Physician Global Assessment (PGA), with psoriasis of the scalp affecting ≥10% of the total scalp area, psoriasis on the trunk and limbs affecting ≥2% of body surface area (BSA), and overall psoriatic involvement of the trunk, limbs and scalp ≤30% of total BSA. One trial (NCT01536938) enrolled patients aged ≥18 years who had experienced psoriasis for a period of ≥6 months. The second trial (NCT02387853) enrolled adolescent patients aged 12 to <17 years. Key eligibility criteria have been reported previously.8,9 In the adult trial, 302 patients were randomly assigned in a 1:1:1 ratio to double-blind treatment with once-daily Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%), or
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