16830 Results from the open-label treatment period of a long-term proactive management phase III trial using fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam

Abstract

Patients received Cal/BD once daily for 4 weeks during the open-label period of this phase III long-term proactive management trial. Patients who achieved treatment success (PGA score ‘clear’/‘almost clear’ with ≥2 grade improvement from baseline) were randomized 1:1 in a double-blind fashion to Cal/BD or vehicle twice weekly for 52 weeks. Patients who did not achieve treatment success were withdrawn from the study. Eligible patients: ≥18 years; truncal and/or limb psoriasis at least ‘mild’ by PGA; covering 2%-30% of body surface area (BSA); with a modified psoriasis area and severity index (m-PASI) of ≥2. End points included: change from baseline in PGA, m-PASI and, BSA, and number of adverse events (AEs). 650 patients entered the open-label phase; 521 (80.2%) achieved treatment success at week 4. More than 90% of patients achieving success had PGA score moderate or severe at baseline (moderate, n = 444 [85.2%]; severe, n = 34 [6.5%]). PGA at week 4 was ‘clear’ (n = 110, 21.1%) and ‘almost clear’ (n = 411, 78.9%) in those achieving success. Mean (SD) m-PASI and mean (SD) BSA at baseline were 7.8 (3.8) and 8.2% (6.2%), respectively, in patients achieving treatment success. Change in mean (SD) m-PASI and BSA from baseline to week 4 was −0.8% (0.2%) and −0.6% (0.4%), respectively, in successful patients. Of the 650 patients assigned to treatment, 115 (17.7%) experienced 157 AEs; 5 patients (0.8%) experienced AEs possibly or probably related to the study drug; and 2 patients (0.3%) withdrew during the open-label phase due to an AE.