Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis

September 2020 | Volume 19 | Issue 9 | Original Article | 874 | Copyright © September 2020


Published online August 21, 2020

Leon H. Kircik MDa, Todd E. Schlesinger MD FAADb, Emil Tanghetti MDc

aIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY bMedical University of South Carolina, College of Medicine, Charleston, SC; Dermatology & Laser Center of Charleston, Charleston, SC; Clinical Research Center of the Carolinas, Charleston, SC cCenter for Dermatology and Laser Surgery, Sacramento, CA

Abstract
Objective: To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.

Methods
: A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.

Results
: 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.

Conclusions
: In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated.

J Drugs Dermatol
. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020

INTRODUCTION

Psoriasis is a chronic inflammatory skin disease.1,2 While there is currently no cure for psoriasis, treatments are available that are aimed at controlling the disease and improving the patient’s quality of life.3

Topical medications (eg, vitamin D analogs and corticosteroids) are the mainstay of therapy for limited or mild disease, which is the type that occurs in the majority of people.2,4 Among the topical agents, the fixed-dose combination formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam is the preferred treatment option for plaque psoriasis, given the favorable efficacy and safety profile demonstrated in several large, randomized, clinical studies, as well as the benefits of the easy-to-use foam formulation.5-10 Real-world clinical experience with Cal/BD foam mirrors that observed in clinical studies, with a majority of healthcare providers reporting that they prescribe Cal/BD foam for its overall efficacy.11 For more extensive or difficult-to-treat disease, the benefits of combination therapy have been demonstrated in clinical studies, acknowledged by guidelines, and generally accepted in clinical practice; about half of all psoriasis treatments involve the use of combination therapy.12-15 Topical medication, in particular, has been used in combination with different therapies, such as traditional systemic agents. Of the latter, apremilast is a systemic agent of interest. It is an oral, small-molecule phosphodiesterase 4 (PDE4) inhibitor that has demonstrated efficacy and safety in pivotal clinical trials and in real-world studies.16-19 Although Cal/BD foam and apremilast are effective and safe on their own, their use in combination had not been evaluated prior to the current study.

With the recent advocation of the treat-to-target strategy by the National Psoriasis Foundation – whereby the goal is to achieve 1% or less of body surface area (BSA) involvement20 – it is becoming increasingly important for both patients and healthcare providers to choose the most effective treatment strategy that will permit the attainment of a more complete response and a favorable clinical outcome. A better understanding of the use