The Maintenance Effect of Calcipotriene 0.05% and Betamethasone Dipropionate 0.064% (Cal/BD) Aerosol Foam in Combination With Apremilast

April 2022 | Volume 21 | Issue 4 | Original Article | 381 | Copyright © April 2022


Published online March 31, 2022

Elif Ozyurekoglu,a Leon H. Kircik MDb,c

aColumbia University, New York, NY
bIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University Medical Center, Indianapolis, IN;
cPhysicians Skin Care, PLLC Louisville, KY; DermResearch, PLLC, Louisville, KY

Abstract
Even in light of significant recent therapeutic advancements, many patients with psoriasis will use a combination of treatments at some point in the disease course. Despite the frequency with which combinations are used in clinical practice, there are few large-scale, randomized controlled trials investigating the use of various combination therapies in psoriasis. Twice-weekly maintenance application of topical Cal/BD aerosolized foam has recently been shown to prolong time to remission and is associated with fewer relapses in patients initially treated with standard dosing of the formulation. Data from a small number of pilot studies suggest potential benefits from the combined used topical Cal/BD foam with oral apremilast.

This pilot study assesses the effect of twice-weekly maintenance doses of Cal/BD foam after 4 weeks of standard once-daily treatment in combination with apremilast. The combination of apremilast plus Cal/BD achieved the primary endpoint, with 95% of subjects rated clear or almost clear on PGA at week 4. Subject’s global assessment scores showed similar improvement to PGA scores at week 4 (47% of subjects clear or almost clear). Ten subjects (53%) achieved PASI 75 at week 4, and 12 (63%) achieved PASI 75 at week 16.

Maintenance dosing of Cal/BD foam in combination with apremilast is safe and effective for the management of moderate psoriasis.

J Drugs Dermatol. 2022;21(4):381-386. doi:10.36849/JDD.6622

INTRODUCTION

Estimates suggest that more than half of all patients with psoriasis are dissatisfied with their treatment.1,2 Even in light of significant recent therapeutic advancements, many patients with psoriasis will use a combination of treatments at some point in the disease course, with the goal to increase the speed and/or degree of therapeutic response. However, despite the frequency with which combinations in clinical practice are used, there are few large-scale, randomized controlled trials investigating the use of various combination therapies in psoriasis.3 Prescribers are challenged to create combination regimens that offer both efficacy and safety.4 In many instances, the combination of a topical agent with a systemic agent is preferred, as the differing modes of administration are expected to reduce the risk for drug interactions.

An increasingly common combination approach pairs apremilast (Otezla, Amgen), an oral phosphodiesterase 4 inhibitor, with a topical aerosol foam formulation of fixed combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD, Enstilar, Leo Pharma).

Apremilast is approved for treatment of moderate to severe psoriasis, and has demonstrated a favorable safety profile.5 It has been suggested by a consensus panel of experts to be particularly appropriate for management of patients with stable moderate psoriasis.6 Relative to conventional oral agents and biologic therapies, apremilast requires less prescreening and monitoring.6 In Phase III trials of apremilast for psoriasis, 33% of subjects receiving active treatment achieved PASI 75 at week 16, compared to 5% of placebo controls.7 Topically applied calcipotriene and betamethasone dipropionate
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