Fixed-Combination Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam Is Well Tolerated in Patients with Psoriasis Vulgaris: Pooled Data from Three Randomized Controlled Studies.

The authors performed a pooled analysis of three randomized, 4-week, phase II/III studies in adult patients with mild to severe psoriasis and assessed the safety/tolerability of aerosol foam fixed-combination calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) versus different comparators. Overall, 1104 patients were randomized to Cal/BD aerosol foam (n=564), Cal aerosol foam (n=101), BD aerosol foam (n=101), aerosol foam vehicle (n=152), Cal/BD ointment (n=135), or ointment vehicle (n=51). A total of 543 Cal/BD patients in the aerosol foam group (96.3%) completed the studies, with only two patients (0.4%) withdrawing as a result of adverse events (AEs). Ninety-five AEs were reported in 78 patients (13.8%) receiving Cal/BD aerosol foam; similar event rates were observed in other groups. The most common AEs with Cal/BD aerosol foam were nasopharyngitis (n=6, 1.1%) and application-site pain (n=4, 0.7%); most AEs were mild (n=71/95; 74.7%). Adverse drug reactions (ADRs) experienced by two or more patients receiving Cal/BD aerosol foam were application-site pain (n=4; 0.7%) and application-site pruritus (n=2; 0.4%). There were no clinically relevant changes in calcium homeostasis. Cal/BD aerosol foam has a positive benefit-risk profile for the treatment of psoriasis vulgaris; the superior efficacy versus Cal/BD ointment and the individual active ingredients is not associated with poorer tolerability.

RCT Entities:   Population Interventions Outcomes