Pooled Analysis Demonstrating Superior Patient- Reported Psoriasis Treatment Outcomes for Calcipotriene/ Betamethasone Dipropionate Cream Versus Suspension/Gel.

ABSTRACT

BACKGROUND: Calcipotriene and betamethasone dipropionate (CAL/BDP) cream is a novel treatment of plaque psoriasis based on PAD™ Technology (PAD-cream) designed to improve patient reported treatment satisfaction and quality of life (QoL). METHOD: A pooled analysis of patient reported outcomes from two phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trials evaluating a total of 1271 patients with mild to moderate plaque psoriasis according to the Physician Global Assessment (PGA) scale. Products were applied once daily for 8 weeks. RESULTS: The proportion of patients evaluating their treatment to have improved by 2 grades to clear or very mild disease on the 5-grade Subject Global Assessment (SGA) scale, defined as SGA Success, was significantly higher in the CAL/BDP PAD-cream group compared to active comparator (CAL/BDP suspension/gel) (week 8, 44.2% vs 27.9%, P<0.0001). A Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating no impact of disease on the patient's life, was obtained by 43.8% of patients at week 8 in the CAL/BDP cream group versus 34.2% in the CAL/BDP suspension/gel group (P=0.0005). CAL/BDP PAD-cream demonstrated significantly greater psoriasis treatment convenience compared to CAL/BDP suspension/gel at all studied time points, including questions addressing greasiness of the formulation and overall satisfaction of treatment. CONCLUSION: CAL/BDP PAD-cream is a novel topical treatment for psoriasis, which through PAD™ Technology offers substantial improvement in QoL and treatment satisfaction for patients. Given these data, CAL/BDP PAD-cream may lead to better adherence to treatment, which ultimately could result in better treatment outcomes in clinical practice. CLINICALTRIALS gov NCT03308799 and NCT03802344. J Drugs Dermatol. 2022;21(3)242-248. doi10.36849/JDD.6611.