Randomized Phase 3 trial demonstrating high efficacy, favourable safety and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis

Abstract

BackgroundThe fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well‐established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD‐cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system.Objectives and MethodsA Phase 3, multicentre, randomised, investigator‐blind, active, and vehicle‐controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in 3 European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD‐cream as well as treatment acceptability compared to CAL/BDP gel and PAD‐cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to week 8.ResultsThe percentage mean change from baseline to week 8 in mPASI for CAL/BDP PAD‐cream (67.5%) was superior compared to PAD‐cream vehicle (11.7%; p<0.0001) and non‐inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least 2‐step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD‐cream (50.7%) compared to PAD‐cream vehicle (6.1%, p<0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p=0.0442). Patient reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD‐cream was rated superior to CAL/BDP gel at week 8 (p<0.0001) and the mean change in DLQI from baseline to week 8 improved statistically significantly more in the CAL/BDP PAD‐cream group compared to both PAD‐cream vehicle (p<0.0001) and CAL/BDP gel (p=0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD‐cream was well‐tolerated.ConclusionCAL/BDP PAD‐cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient reported treatment convenience.