Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris – a Randomized Phase III Study (PSO-FAST)
December 2015 | Volume 14 | Issue 12 | Original Article | 1468 | Copyright © December 2015
Craig Leonardi MD,a Jerry Bagel MD,b Paul Yamauchi MD,c David Pariser MD,d Zhenyi Xu MD,e Martin Olesen MD,e* Marie Louise østerdal MSc,e and Linda Stein Gold MDf
aSaint Louis University School of Medicine, St Louis, MO
bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ cDavid Geffen School of Medicine at UCLA, Los Angeles, CA
dEastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA
eLEO Pharma A/S, Ballerup, Denmark
fHenry Ford Health System, Detroit, MI
*LEO Pharma employee at time of study
OBJECTIVE: To compare the efficacy and safety of Cal/BD aerosol foam with aerosol foam vehicle in patients with psoriasis.
DESIGN: Phase III, double-blind, randomized PSO-FAST (Cal/BD foam in PSOriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study recruited patients with ≥ mild severity psoriasis of the trunk and/or limbs from 27 US outpatient sites (NCT01866163). Patients were randomized (3:1) to Cal/BD foam or vehicle once-daily for 4 weeks. Primary outcome: proportion of patients at week 4 who achieved treatment success according to physician’s global assessment. Secondary outcomes: modified (excluding head) psoriasis area and severity index (mPASI) and patient's assessment of itch (visual analog scale). Safety was monitored by adverse events/calcium homeostasis.
RESULTS: 426 patients enrolled between June and October 2013 (Cal/BD foam, n=323; vehicle, n=103). At week 4, significantly more patients using Cal/BD foam achieved treatment success versus vehicle (53.3 versus 4.8%; OR 30.3, 95% CI 9.7,94.3; P < .001) and mean mPASI score was significantly lower for patients using Cal/BD foam than vehicle (2.0 versus 5.5; adjusted difference –3.3, P <.001). Significantly greater itch relief was observed for patients using Cal/BD foam than vehicle (P = .010 at day 3, P < .001 from day 5). Adverse drug reactions were reported in 10 Cal/BD foam patients (3.1%) and two vehicle patients (1.9%); events occurred in one patient each except application site pain (Cal/BD foam, two patients; vehicle, one patient). There were no clinically significant changes in calcium homeostasis.
CONCLUSIONS: Cal/BD foam was efficacious, achieved rapid itch relief and was well tolerated in patients with body psoriasis. This innovative aerosol foam formulation is expected to become a valuable treatment option.
J Drugs Dermatol. 2015;14(12):1468-1477.