A pooled analysis of randomized, controlled, Phase 3 trials investigating the efficacy and safety of a novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis

Document Type

Conference Proceeding

Publication Date

5-27-2022

Publication Title

J Clin Aesthet Dermatol

Abstract

Background: Calcipotriol and betamethasone dipropionate (50mcg/g CAL and 0.5mg/g BDP) cream (CAL/BDP cream) is based on PAD Technology which for the first time has enabled the development of an easy to apply water-containing cream formulation of CAL and BDP. This pooled analysis analyzes the combined efficacy and safety from two Phase 3 studies conducted in the United States and Europe. Methods: CAL/BDP cream was evaluated in two head-to-head, Phase 3, randomized, multicenter, investigator-blind, parallel-group trials comparing the efficacy and safety of CAL/BDP cream to vehicle and an active comparator (50 mcg/g CAL and 0.5mg/g BDP gel/topical suspension (TS)) in adults with psoriasis vulgaris. Eligible participants were adults with a clinical diagnosis of plaque psoriasis involving the trunk and/or limbs. Additional key inclusion criteria included a treatment area involving between 2% and 30% of the body surface area and a physician global assessment (PGA) score of mild or moderate disease severity. Eligible participants were randomly assigned into three treatment groups with a ratio of 3:1:3 for treatment with CAL/ BDP cream, matching vehicle, and CAL/BDP gel/TS. Participants were instructed to apply the treatment topically once daily to affected areas for up to eight weeks. Statistical analyses were based on a modified intention-to-treat population (n=1271), which included all randomized participants who had at least one efficacy assessment after the baseline visit. Results: The percentage of subjects achieving PGA treatment success at Week 8 was statistically significantly higher in the CAL/BDP cream group (43.2%) compared to the CAL/BDP gel/TS group (31.9%) (p<0.0001). Moreover, these statistically significant differences in PGA between CAL/BDP cream and CAL/BDP gel/TS were observed as early as Week 4 (p=0.0001). The mean percent reduction in mPASI score from Baseline to Week 8 was statistically greater for CAL/BDP cream (64.6%) than CAL/BDP gel/TS (56.4%) (p<0.0001). The difference in mPASI treatment effect between CAL/ BDP cream and CAL/BDP gel/TS was statistically significant as early as Week 1 (p=0.0009). In addition, the proportion of subjects obtaining mPASI75 was greater in the CAL/BDP cream group than in the CAL/BDP gel/TS group at Week 4 (22.1% vs. 13.7%) (p=0.0004) and at Week 8 (44.3% vs. 34.5%) (p=0.0011). The mean DLQI improvement from Baseline, at Week 8, was significantly greater for CAL/BDP cream (6.5 points) compared to CAL/ BDP gel/TS (5.6 points) (p<0.0001). CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/ TS with no adverse drug reactions with a frequency being > 1 % , associated with the CAL/BDP cream. Conclusion: The present analysis of pooled data from two randomized, controlled Phase 3 trials investigated the efficacy and safety of a CAL/BDP cream for the topical treatment of psoriasis. The results demonstrated statistically significant greater efficacy in favor of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and PASI75 compared to CAL/BDP gel/TS. Based on the unique combination of high efficacy, favorable safety and convenience of treatment in a single product, CAL/BDP cream can be considered a firstline topical therapy of psoriasis.

Volume

15

Issue

4 SUPPL 1

First Page

S22

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