A Prospective, Open-Label Study Evaluating Adjunctive Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Psoriasis Patients With Inadequate Response to Biologic Therapy
August 2018 | Volume 17 | Issue 8 | Original Article | 845 | Copyright © August 2018
Jerry Bagel MD MS, James Zapata, and Elise Nelson LPN CCRC
Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
Abstract
Objective: To assess the effectiveness and safety of combining calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam with biologic therapies for patients with plaque psoriasis who have not obtained an adequate response with biologic therapy.
Methods: This was a prospective, open-label, single-arm study of patients with chronic plaque-type psoriasis (body surface area [BSA] ≤5%) who were being treated with biologic agents for ≥24 weeks. All patients received once-daily Cal/BD foam for 4 weeks, followed by twice-weekly use on consecutive days for 12 weeks (maintenance regimen). The end points were assessed at weeks 4 and 16, and included the Physician’s Global Assessment (PGA), BSA, PGA×BSA, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM)-9. Safety evaluations included assessments of local skin reactions and adverse events (AEs).
Results: Enrolled were 25 patients (18 men and 7 women; mean age, 53 ± 11 years). Patients had significant disease activity despite being on stable biologic therapy (median values: BSA, 3%; PGA, 3; PGA×BSA, 8). At weeks 4 and 16 versus baseline, adjunctive therapy with Cal/BD foam significantly improved PGA score (1 vs 1 vs 3; P less than .01), BSA involvement (1% vs 1% vs 3%; P less than .01), and PGA×BSA measure (1 vs 1 vs 8; P less than .01). Most patients achieved treat-to-target criteria for BSA ≤1% and PGA ≤1 at week 4 (both 76%) and week 16 (both 68%) versus 12% and 4%, respectively, at baseline. Quality of life was improved at both weeks 4 and 16, with high treatment satisfaction. Overall, adjunctive Cal/BD foam was safe and well-tolerated, with no serious AEs.
Conclusions: Adjunctive therapy with Cal/BD foam was associated with an improvement of every measure of disease activity in patients with inadequate response to biologics, an effect that was maintained throughout the study. The majority of patients achieved treat-to-target goals.
J Drugs Dermatol. 2018;17(8):845-850.
INTRODUCTION
Psoriasis is a chronic inflammatory skin disease that affects as many as 7.4 million adults in the United States.1,2 It is characterized by disfiguring, scaling, erythematous plaques that can be painful or severely pruritic.1 People with psoriasis are at risk for significant morbidity and comorbidity, and they also have a poor quality of life, comparable to that reported with other chronic diseases, such as cancer.3The goals of psoriasis treatment are to control clinical symptoms of the skin, reduce systemic disease potential, and improve patient quality of life.4 For mild to moderate psoriasis, topical therapies used as monotherapy or in combination with other treatments, including phototherapy, systemic therapy, and biologic therapy, are the mainstay of management.5,6 Corticosteroids and vitamin D analogues are the cornerstones of topical treatment, and combination formulations with these 2 agents are among the recommended, and preferred, first-line treatments.6 Moderate to severe psoriasis, on the other hand, typically requires systemic therapy (eg, with biologics).1 Biologics are protein-based drugs that target specific molecules involved in the immunopathogenesis of psoriasis.5 Some of the commonly used biologics are adalimumab, ustekinumab, secukinumab, etanercept, and ixekizumab. Biologics are recommended for patients who have inadequate response to, are not eligible for, or are unable to tolerate traditional systemic agents.5Despite the availability of various treatment options, many patients with psoriasis remain untreated, and among those who are treated, about half are dissatisfied with their treatment.7 A “treat-to-target” strategy has been proposed by the National Psoriasis Foundation, specifically, treating to ≤1% of body surface area (BSA) involvement at 3 months after treatment initiation or at each 6-month follow-up on a maintenance regimen.8 This goal may motivate patients
