Pooled Analysis Demonstrating Superior Patient- Reported Psoriasis Treatment Outcomes for Calcipotriene/ Betamethasone Dipropionate Cream Versus Suspension/Gel
March 2022 | Volume 21 | Issue 3 | Original Article | 242 | Copyright © March 2022
Published online February 28, 2022
April W. Armstrong MD,a Andreas Pinter MD,b Johan Selmer MD,c Morten Præstegaard PhD,c Adam Reich MD,d John Koo MDe
aUniversity of Southern California, Los Angeles, San Francisco, CA, USA
bUniversity Hospital Frankfurt am Main, Department of Dermatology, Frankfurt am Main, Germany
cMC2 Therapeutics, Hørsholm, Denmark
dDepartment of Dermatology, University of Rzeszów, Rzeszów, Poland
eUniversity of California, San Francisco, Department of Dermatology, Psoriasis and Skin Treatment Center, San Francisco, CA, USA
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. doi:10.36849/JDD.6611
INTRODUCTION
Atrusted and well-known topical treatment of plaque psoriasis is the fixed-dose combination of calcipotriene (CAL; Vitamin D analogue) and betamethasone dipropionate (BDP; corticosteroid). There is a solid scientific rationale for the combination of a Vitamin D analog and a corticosteroid.1-3 The efficacy and safety of topical formulations containing fixed-dose combinations of CAL and BDP have repeatedly been demonstrated in clinical trials.4-7 The CAL/ BDP combination is recommended by European guidelines, the Canadian Dermatology Association,8 and the joint AADNPF guidelines.9 However, the combination of CAL/BDP is challenging to formulate into a topical treatment. In an aqueous environment, CAL and BDP are incompatible because CAL requires basic conditions to maintain stability, whereas betamethasone requires acidic conditions. Therefore, the already marketed CAL/BDP fixed-dose combination products are non-aqueous paraffin or liquid oil-based formulations,10,11 which can be sticky, greasy, and inconvenient to use for many patients.12 Psoriasis patients generally prefer light, moisturizing, and quickly absorbed vehicles such as lotion, foam, or cream over ointment for ease of use and cosmetic acceptability.13,14 Topical treatment of psoriasis is demanding, time-consuming and can interfere with daily routines, which often result in lack of adherence to treatment and consequently suboptimal treatment outcomes.15 An aqueous cream fixeddose combination of 0.005 w/w% CAL and 0.064 w/w% BDP has been developed using the proprietary PADTM Technology that protects the drug substances from degradation during storage
