• Efficacy analyses of scalp psoriasis, included patients with scalp involvement of at least 10% and a PGA on the scalp of at least mild severity (grade 2) at baseline (CAL/BDP cream n=112; vehicle n=38; Table 1). • The PGA treatment success on the scalp was significantly greater for CAL/BDP cream (50.8%) than for vehicle (9.3%) at Week 8 (p=0.0002) with comparable differentiation between the two arms also present at Week 4 (p=0.0051) and Week 6 (Figure 1). • At Week 1, 17 (15.2%) patients in the CAL/BDP cream group and 0 (0.0%) patients in the vehicle group achieved PGA treatment success on the scalp (Figure 1). RESULTS Andreas Pinter1, Morten Præstegaard2, Johan Selmer2, Adam Reich3 1University Hospital Frankfurt am Main, Dept. of Dermatology, Frankfurt am Main, Germany; 2MC2 Therapeutics, Hørsholm, Denmark; 3Medical College of Rzeszów University, Dept. of Dermatology, Rzeszów, Poland CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE CREAM DEMONSTRATES HIGH TREATMENT SUCCESS IN PATIENTS WITH SCALP PSORIASIS Table 1. Number of patients and baseline disease • Calcipotriene and betamethasone dipropionate (50 microgram/g CAL and 0.5 mg/g BDP) cream (CAL/BDP cream) is based on PADTM Technology enabling development of an easy to apply, aqueous cream of CAL and BDP, despite their known pH-related instability when combined in the presence of water. • The objective of this subgroup analysis is to present data from a Phase 3 trial conducted in Europe on the efficacy of CAL/BDP cream in scalp psoriasis. INTRODUCTION • W riting support was provided by Anja Snel-Prentø. • The study was funded by MC2 Therapeutics. ACKNOWLEDGEMENTS CONCLUSIONS • The scalp is a common location of involvement of plaque psoriasis and successful management of scalp psoriasis includes topical therapies that are effective and acceptable to the patient. • CAL/BDP cream is a novel topical treatment for plaque psoriasis based on PAD™ Technology. • CAL/BDP cream demonstrated high PGA treatment success and satisfaction, fast onset of action and a favourable safety profile in patients with scalp psoriasis. METHODS • Efficacy and safety of CAL/BDP cream was evaluated in a Phase 3, randomized, multicenter, investigator-blind, parallel-group trial. Patients were instructed to apply the trial medication topically once daily to affected areas for up to 8 weeks. • Efficacy analyses of scalp psoriasis, included patients with scalp involvement of at least 10% and a Physician’s Global Assessment (PGA) on the scalp of at least mild severity (grade 2). • The percentage of patients with PGA success on the scalp was defined as a minimum two-grade decrease from Baseline to Week 8 in PGA score of psoriasis severity on the scalp to clear (grade 0) or almost clear (grade 1). • Statistical analyses of PGA treatment success were based on multiple imputations and a treatment policy strategy on the Full Analysis Set, scalp psoriasis subgroup using a logistic regression model including randomized treatment and analysis site as independent variables. • PGA treatment satisfaction defined as clear (grade 0) or almost clear (grade 1) disease was analyzed using descriptive statistics based on Observed Cases. Figure 3. Improvement of scalp psoriasis after treatment with CAL/BDP cream Pictures from MC2-01-C7 phase 3 trial; Informed consent to publish pictures has been obtained from the patient. Figure 1. PGA treatment success on the scalp by weeks of treatment PGA, Physician’s Global Assessment. BDP, betamethasone dipropionate; CAL, calcipotriene. • 29.5% of patients in the CAL/BDP cream group achieved PGA treatment satisfaction (clear or almost clear) on the scalp already at week 1, increasing to 68.2% at week 8 compared to 25.0% in the vehicle group (Figure 2). • Figure 3 shows representative examples of patients achieving PGA treatment success on the scalp at Week 1 and clearance at Week 4 after treatment with CAL/BDP cream. • Overall, safety assessments during the trial demonstrated that CAL/BDP cream was well-tolerated. Figure 2. PGA treatment satisfaction on the scalp by weeks of treatment CAL/BDP Cream Vehicle Number of patients in the full analysis set 213 68 Number of patients in the Scalp Analyses 112 38 PGA on the scalp at baseline: Mild (PGA grade 2) 55 17 Moderate (PGA grade 3) 53 21 Severe (PGA grade 4) 4 0 Full analysis set, scalp psoriasis subgroup, Treatment policy strategy, Multiple imputations. P-values represent comparison between CAL/BDP cream and vehicle * 15.2 29.2 44.3 50.8 0.0 3.1 7.0 9.3 0 10 20 30 40 50 60 0 2 4 6 8 % P G A t re a tm e n t s u c c e s s Weeks Cal/BDP Cream Vehicle 29.5 51.8 63.3 68.2 0.0 12.1 15.6 25.0 0 20 40 60 80 0 2 4 6 8 % P G A t re a tm e n t s a ti s fa c ti o n Weeks Cal/BDP Cream Vehicle Baseline Week 1 Week 4 Week 8 p=0.0002 p=0.0051 Full analysis set, scalp psoriasis subgroup, Observed cases.