Effect of Calcipotriene/Betamethasone Dipropionate 0.005%/0.064% Foam on Target Lesions in Plaque Psoriasis: A Post-Hoc Analysis
February 2020 | Volume 19 | Issue 2 | Original Article | 121 | Copyright © February 2020
Published online January 24, 2020
Karen A. Veverka PhD,ª Dharm S. Patel PhD,ª Tobias Anger,b Jes B. Hansen PhD,b James Del Rosso DO,c and Leon Kircik MDd
ªLEO Pharma, Madison, NJ bLEO Pharma, Ballerup, Denmark cJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV dIcahn School of Medicine at Mount Sinai, New York, NY Indiana University Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY
OBJECTIVE: Investigate the effect of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam on target lesion severity in plaque psoriasis.
DESIGN: Post-hoc analysis was conducted on data from a Phase 3, randomized, double-blind, multicenter clinical study of Cal/BD foam in the treatment of psoriasis vulgaris for 4 weeks (PSO-FAST; NCT01866163).
PARTICIPANTS: In PSO-FAST, 426 patients (≥18 years) with psoriasis vulgaris (≥mild severity) were randomized 3:1 to Cal/BD foam (n=323) or vehicle foam (n=103), applied once daily.
MEASUREMENTS: Assessments included (1) target lesion severity (redness, scaliness, and thickness) at baseline and weeks 1, 2, and 4; and (2) the proportion of patients with ≥50% reduction in total sign score (TSS-50) from baseline at weeks 1, 2, and 4.
RESULTS: A greater proportion of patients achieved considerable improvement (a score of 0 or 1) in the severity of target lesions after 4 weeks of treatment with Cal/BD foam vs vehicle foam at week 4 (redness: 76.2% vs 21.4%; P<.001; scaliness: 91.3% vs 61.2%; P<.001; and thickness: 83.3% vs 35.0%; P<.001, respectively). Rapid onset of efficacy was observed as early as week 1. Significantly more patients also achieved TSS-50 at week 4 with Cal/BD foam vs vehicle foam for their target lesions regardless of treatment area, including the elbows and knees (P<.05 for all).
CONCLUSIONS: Significant improvements in target lesion severity were achieved with up to 4 weeks of treatment with once-daily Cal/BD foam for adults with plaque psoriasis versus vehicle foam, with rapid onset of efficacy observed at week 1. J Drugs Dermatol. 2020;19(2)121-126 doi:10.36849/JDD.2020.4750
Psoriasis is a common, chronic, inflammatory skin disease that affects approximately 7 million adults in the United States and many more worldwide.1,2 The characteristic scaling and erythematous plaques of the disease can be disfiguring and, in addition, painful, or severely pruritic.3 In fact, psoriasis can be detrimental to the physical, social, and psychosocial well-being of the individual, so much so that the disutility and deterioration in quality of life felt by these patients can often be comparable to other serious chronic diseases, according to a systemic literature review.4,5 Morphologic evaluation of these plaques or skin lesions is important in diagnosis and in classification of the psoriasis subtype within the disease spectrum. Plaque psoriasis, for example, the most common form of the disease—manifests as well-defined, sharply demarcated, erythematous plaques of varying size.3 These lesions commonly appear as areas of scaly skin, red raised areas on the skin, dry skin, and crusty plaque features that contribute to the burden of the disease and are associated with the worst quality of life from psoriasis for patients.5 Disease severity in psoriasis is determined by the amount of redness, scaliness, and thickness of the lesions, either across different body regions or on a predefined target lesion, or both. The Psoriasis Area and Severity Index (PASI) is the gold standard for measuring psoriasis severity.6,7
There is no cure for plaque psoriasis at the present time, leaving the goal of treatment to be achievement of complete clearance of skin symptoms and improvement in the patient’s quality of life.8 Despite a rapidly evolving treatment landscape for psoriasis, topical corticosteroids and vitamin D3 analogues