Efficacy and safety of an innovative aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis-the PSO-FAST study
J Am Acad Dermatol
Background: An innovative aerosol foam formulation of the fixed combination calcipotriene (Cal) 0.005% plus betamethasone dipropionate (BD) 0.064% has been developed to improve treatment for patients (pts) with psoriasis vulgaris. Aims: To assess the efficacy and safety of the Cal/BD foam vs foam vehicle in pts with psoriasis of the body. Methods: PSO-Fast (Cal/BD foam in PSOriasis vulgaris, a Four-week, vehiclecontrolled, efficacy And Safety Trial; NCT01866163) was a large, phase III, double-blind trial in which pts aged ≥18 y with mild-to-severe plaque psoriasis were randomized 3:1 to once-daily Cal/BD foam or vehicle. The primary efficacy endpoint was the proportion of pts at Week 4 who achieved 'clear' or 'almost clear' (pts with ≥ moderate disease at baseline) or 'clear' (pts with mild disease at baseline), according to the Physician's Global Assessment of disease severity; defined as 'treatment success'. Additional endpoints included modified (excluding the head, which was not treated) Psoriasis Area and Severity Index (mPASI) and the patient's assessment of itch. Safety was monitored throughout. Results: 426 pts, median age 51 y (range 18-87), were randomized to Cal/BD foam (n = 323) or vehicle (n = 103). The overall completion rate was 97%. At Week 4, a significantly larger proportion of Cal/BD foam-treated pts achieved 'treatment success' vs vehicle (53% vs 5%; OR 30.3, 95% CI 9.7, 94.3; P <.001; multiple imputation applied for missing data). The mean mPASI score was significantly lower for Cal/BD foam vs vehicle, both at Weeks 1 (4.66 vs 5.93; difference -1.3, 95% CI -1.8, -0.8; P<.001) and 4 (2.04 vs 5.33; difference -3.3, 95% CI -3.9, -2.7; P<.001). At Week 4, the mean percentage decrease in mPASI score was greater for Cal/BD foam than for vehicle (-72% vs -26%). Itch relief was observed as early as Day 3 and was significantly greater with Cal/BD foam vs vehicle at all time points (P =.010 at Day 3, P<.001 at Day 5, Weeks 1, 2, and 4). Adverse drug reactions were reported in 10 pts (3%) in the Cal/BD foam group and 2 (2%) in the vehicle group; all were single events except for 'application site pain' (Cal/BD foam, n=2; vehicle, n=1). There were no clinically significant changes in albumin-corrected serum calcium or calcium: creatine ratio. Conclusions: The fixed combination Cal/BD foam was found to be effective and well tolerated in pts with psoriasis of the body. Our findings indicate that the Cal/BD foam formulation achieves rapid itch relief.