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

Keywords

betamethasone dipropionate, calcipotriol, adult, body surface, clinical trial, comparative effectiveness, conference abstract, controlled study, cream, Dermatology Life Quality Index, drug safety, drug therapy, Europe, female, human, limb, male, meta analysis, multicenter study (topic), parallel design, phase 3 clinical trial (topic), physician, psoriasis, Psoriasis Area and Severity Index, psoriasis vulgaris, randomized controlled trial (topic), suspension, topical drug administration, topical treatment, trunk, United States

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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