Gold LS, Green LJ, Dhawan S, Kirsch A, Selmer J, and Praestegaard M. Rapid and clinically meaningful improvement of plaque psoriasis-associated itch after treatment with calcipotriol and betamethasone dipropionate cream. J Dtsch Dermatol Ges 2022; 20:32-32.
J Dtsch Dermatol Ges
Introduction: Calcipotriol (50 mcg/g CAL) and betamethasone dipropionate (0.5 mg/g BDP) cream (CAL/BDP cream) is a novel topical treatment for plaque psoriasis. CAL/BDP cream is based on PAD™ Technology, which in a single product enables a combination of efficacy, safety and patient satisfaction. Here, we present data from a pivotal phase 3 trial demonstrating substantial and clinically meaningful improvement of itch in patients with psoriasis.
Methods: Head-to-head, Phase 3, randomized, multicenter, investigator-blind, parallel-group trial comparing the efficacy and safety of CAL/BDP cream vs vehicle and active comparator (CAL/BDP gel/Topical Suspension (TS)) in adults with psoriasis. Itch evaluation: 11-point peak pruritus numeric rating scale (NRS). Itch reduction evaluation: absolute change in peak pruritus NRS score from baseline, and responder analysis defining itch treatment success as at least 4 points improvement in peak pruritus NRS score from baseline. A total of 796 patients at 55 clinical sites across the United States were enrolled; 626 patients out of 796 had a peak pruritus NRS score of at least 4 at baseline. Patients applied study medication once daily for up to 8 weeks.
Results: At week 4, CAL/BDP cream showed superior reduction of peak pruritus NRS score vs vehicle (3.5 vs 1.1 points of improvement; p < 0.0001). At weeks 1 and 8, CAL/BDP cream also demonstrated significant reduction in peak pruritus NRS score compared with vehicle (p < 0.0001) and at week 8 compared with CAL/BDP gel/TS (p < 0.05). Among patients who had at least a peak pruritus NRS score of 4 at baseline, there was a higher patient proportion achieving a clinically relevant improvement of at least 4 points from baseline to week 4 in the CAL/BDP cream group (60.3 %) vs vehicle (21.4 %) (p<0.0001). CAL/BDP cream further demonstrated a significantly greater proportion of patients achieving at least 4 points improvement in peak pruritus NRS score during week 1 of treatment in comparison to CAL/BDP gel/ TS (44.0 % vs 36.9 %; p = 0.0241), thereby underlining the rapid CAL/BDP cream onset of action.
Conclusions: Itch is a plaque psoriasis key symptom. PAD™ Technology based CAL/BDP cream, a novel topical treatment of psoriasis, demonstrated a significant improvement of the proportion of patients achieving a minimum 4-point improvement on the peak pruritus NRS score at week 4.