MC2-01 Cream Has Improved Overall Psoriasis Treatment Efficacy Compared to Calcipotriene Plus Betamethasone Dipropionate Topical Suspension

Document Type

Conference Proceeding

Publication Date

8-2019

Publication Title

J Psoriasis Psoriatic Arthritis

Abstract

Introduction: MC2-01 cream is a novel topical treatment of psoriasis containing the active ingredients calcipotriene and betamethasone dipropionate (0.005%/0.064% [wt/wt], CAL/ BDP). MC2-01 cream is based on PAD Technology and designed for high penetration of the actives combined with excellent cosmetic elegance. Data from a phase 3 trial are presented comparing overall efficacy of MC2-01 cream to CAL/BDP topical suspension ('CAL/BDP TS') in adults with mild-to-moderate psoriasis. Methods: The phase 3, randomized, multicenter, investigatorblind, parallel-group trial evaluated the efficacy and safety of MC2-01 cream compared to MC2-01 vehicle and CAL/BDP TS (sourced as Taclonex Topical Suspension) in adult patients with psoriasis vulgaris on the body. The trial enrolled 796 patients at 55 clinical sites across the United States: MC2-01 cream (n=343), CAL/BDP TS (n=338), and MC2-01 vehicle (n=115). Patients applied trial medication once daily for 8 weeks. The primary objective was to show therapeutic noninferiority of MC2-01 cream to CAL/BDP TS, as well as to characterize the safety profile of MC2-01 cream in patients with psoriasis vulgaris. The primary efficacy end point was the proportion of patients with treatment success at week 8, defined as minimum 2-point decrease from baseline in Physician Global Assessment (PGA) score. Results: The phase 3 trial met its primary objective to demonstrate noninferiority of MC2-01 cream to CAL/BDP TS on PGA treatment success at week 8 (MC2-01 cream 40.1% vs CAL/BDP TS 24.0% vs MC2-01 vehicle 4.5%). The primary objective was also met for the secondary end point percentage reduction in mPASI from baseline to week 8. Additional analysis of PGA treatment success showed that MC2-01 cream is superior to CAL/BDP TS at week 4 (P < .0001) and week 8 (P < .0001). Further analyses of percentage reduction in mPASI from baseline confirmed that MC2-01 cream has superiority to CAL/BDP TS throughout treatment from week 1 (26.2% vs 18.9%, P < .001) to week 8 (64.8% vs 52.3%, P < .0001). MC2-01 cream also provided reduction in itch compared to vehicle measured by the proportion of patients having minimum 4-points improvement on an 11-point numeric rating scale of itch severity (60.2% vs 21.4% at week 4, P < .01). The safety profile of MC2-01 cream was similar to that known for CAL/BDP products. Conclusions: The phase 3 trial showed that MC2-01 cream is a substantial improvement in overall efficacy and onset of action for topical treatment of psoriasis compared to CAL/BDP TS. Enhanced patient satisfaction enabled by the MC2-01 cream PAD Technology may increase treatment compliance among patients, and positively impact real-life treatment outcomes even further. As such, PAD Technology holds the promise of redefining topicals.

Volume

4

Issue

3

First Page

166

Last Page

167

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