Efficacy, Convenience, and Safety of Calcipotriene-Betamethasone Dipropionate Cream in Skin of Color Patients With Plaque Psoriasis

July 2023 | Volume 22 | Issue 7 | 668 | Copyright © July 2023


Published online June 28, 2023

Christina L. Kontzias BAa, Alyssa Curcio BAa, Brandon Gorodokin BAb, Kristin A. Tissera BAb, Steven R. Feldman MD PhDa,c,d, Neal Bhatia MDe, Valerie D. Callender MDf, Leon Kircik MDb

aCenter for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC
bIcahn School of Medicine at Mount Sinai, Department of Dermatology, New York City, NY
cDepartment of Pathology, Wake Forest University School of Medicine, Winston-Salem, NC
dDepartment of Social Sciences & Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC
eTherapeutics Clinical Research, San Diego, CA 
fDepartment of Dermatology, Howard University College of Medicine, Washington, District of Columbia; Callender Dermatology & Cosmetic Center, Glenn Dale, MD

Abstract
Background: Psoriasis affects diverse racial and ethnic groups. In July 2021, the US Food and Drug Administration approved calcipotriene/betamethasone dipropionate (CAL/BDP) 0.005%/0.065% cream to treat plaque psoriasis in adults. The efficacy and safety of CAL/BDP in patients with skin of color (SOC) who have psoriasis is not well characterized.
Method: A post hoc analysis of phase 3 clinical trial data (NCT03308799) was conducted to assess the efficacy, convenience, and safety of CAL/BDP cream versus CAL/BDP topical solution and vehicle cream in people with Fitzpatrick skin types IV to VI.  
Results: This study included 784 participants, 280 (35.7%) of whom had Fitzpatrick skin types IV to VI. Patients treated with CAL/BDP cream had greater disease improvement, treatment convenience scores, and overall satisfaction than those treated with CAL/BDP topical solution in the subgroup with skin types IV to VI and the total study population.  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms. 
Conclusion: Psoriasis is associated with a greater physical and psychosocial impact in patients with SOC. While many effective topical therapies exist, it may be helpful to conduct separate analyses of patients with SOC to assess the efficacy and safety of treatment in this population. This sub-analysis of phase 3 clinical trial data supports the efficacy and safety of CAL/BDP cream in the treatment of plaque psoriasis in patients with SOC. CAL/BDP cream also had greater convenience, formula acceptability, and overall satisfaction in both the subgroup with SOC and the total trial population, which may improve adherence to topical therapy and treatment outcomes for people with SOC who have psoriasis.

Kontzias CL, Curcio A, Gorodokin B, et al. Efficacy, convenience, and safety of calcipotriene-betamethasone dipropionate cream in skin of color patients with plaque psoriasis. J Drugs Dermatol. 2023;22(7):668-672. doi:10.36849/JDD.7497.

INTRODUCTION

Psoriasis is a chronic inflammatory skin condition that affects diverse racial and ethnic groups. The US prevalence is 3.7% in White individuals, 2.0% in Black individuals, and 1.6% in Hispanic individuals/others.1 However, the prevalence of psoriasis in the Black and Hispanic populations may be underestimated. Due to systemic and sociocultural barriers, psoriasis is less likely to be diagnosed in non-White individuals than in White individuals.1

Numerous treatments have been developed for psoriasis. First-line treatment for mild-to-moderate psoriasis is topical treatment, including corticosteroids, vitamin D analogs, keratinolytics, calcineurin inhibitors, salicylic acid, and tar.2 Topical vitamin D analog/corticosteroid combination therapy is a common treatment and is superior to vitamin D analogs or corticosteroids alone.3 Several topical formulations of calcipotriene and betamethasone dipropionate (CAL/BDP) have been approved for treating psoriasis, including a foam, topical suspension, and gel formulation. In July 2021, the US Food and Drug Administration approved a cream formulation of CAL/BDP 0.005%/0.065% for plaque psoriasis in adults.4 In an 8-week, phase 3 clinical trial (NCT03308799), once daily CAL/BDP cream was more effective, had a faster onset of action, greater itch reduction, and a greater treatment convenience score than the CAL/BDP topical solution or placebo.5

However, the efficacy and safety of this medication for psoriasis in patients with skin of color (SOC) is not well characterized. Genetic differences in various ethnic and racial groups may
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