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

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 These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated.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