Adjunctive Use of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Patients With Psoriasis Treated With Ixekizumab

March 2022 | Volume 21 | Issue 3 | Original Article | 235 | Copyright © March 2022


Published online February 24, 2022

doi:10.36849/JDD.6396

Jerry Bagel MD MS, Elise Nelson LPN CCRC

Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ

Abstract
Objective: To examine the effectiveness and safety of adjunctive treatment with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adult patients with chronic plaque psoriasis who have localized residual plaques after ≥24 weeks of treatment with ixekizumab biologic therapy.
Methods: This study was a prospective, open-label, single-arm study of adult patients with moderate-to-severe chronic plaque psoriasis who had suboptimal response after ≥24 weeks of treatment with ixekizumab (residual 3–8% body surface area [BSA] involvement). All patients continued treatment with ixekizumab and received once-daily Cal/BD foam for 4 weeks, followed by every other day for weeks 8 to 12. The primary endpoint was treat-to-target BSA ≤1% at week 4. Additional endpoints included the Physician’s Global Assessment (PGA) score, PGA×BSA, and the patient-reported Dermatology Life Quality Index (DLQI). Safety evaluations included assessments of adverse events (AEs) and local skin reactions.
Results: Among 25 enrolled patients, 36% were female, and the mean age was 50 years. After 4 weeks of daily Cal/BD foam, 56% of patients achieved the treat-to-target goal of ≤1% BSA. Mean % BSA involvement, mean PGA score, and composite PGA×BSA score decreased 4 weeks after the addition of Cal/BD foam. Improvements in disease severity outcomes were maintained after reducing Cal/BD dosing frequency. Cal/BD was generally safe and well-tolerated, with no serious AEs reported.
Conclusion: In real-world clinical practice, for patients with moderate-to-severe plaque psoriasis who had residual plaques following ≥24 weeks of ixekizumab monotherapy, adjunctive treatment with Cal/BD foam was associated with notable and sustained improvements in disease control.

J Drugs Dermatol. 2022;21(3): 235-240. doi:10.36849/JDD.6396

INTRODUCTION

Psoriasis is a chronic, immune-mediated inflammatory disease affecting approximately 3% of the US population.1 The pathogenesis of psoriasis involves keratinocyte hyperproliferation, which manifests as itchy, scaly erythematous plaques on the skin.2-4 Psoriasis is associated with significant morbidity and an increased risk of comorbid disease including cardiovascular and metabolic diseases.5 Psoriasis negatively impacts health-related quality of life (HRQoL) and work productivity.6 Treatments for psoriasis include topical therapies, phototherapy, and systemic drugs depending on disease severity.2,3 While the majority of patients with mild-to-moderate psoriasis can achieve disease control with topical agents or phototherapy, moderate-to-severe psoriasis often necessitates treatment with biologics to adequately control disease.3

Despite the availability of multiple treatment options, an unmet need remains in the treatment of psoriasis. Findings from a population-based National Psoriasis Foundation (NPF) US survey indicated considerable nontreatment and undertreatment of psoriasis.7 Moreover, treatment dissatisfaction was high, with 52% of adults with psoriasis reporting dissatisfaction with their treatment.7 To improve disease monitoring and management, the NPF established treatment targets for plaque psoriasis. Specifically, the target response after treatment initiation was defined as ≤1% of body surface area (BSA) involvement at 3 months and at 6-month follow-up during treatment maintenance.8

Topical vitamin D analogs (eg, calcipotriene), corticosteroids (eg, betamethasone), and the combination of these drugs are a mainstay of psoriasis treatment.2,9 Calcipotriene and betamethasone (Cal/BD) foam is a fixed combination of calcipotriene (50 mcg/g) and betamethasone dipropionate (0.64 mg/g) and is indicated for the topical treatment of plaque psoriasis in patients aged ≥18 years.10 Previous studies have