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 © 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
INTRODUCTION: An innovative aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) designed to improve treatment outcomes.
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.
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Psoriasis vulgaris is a chronic inflammatory disease characterized by scaly plaques of thickened skin.1,2 The World Health Organization views psoriasis as a disabling, painful disease associated with multiple comorbidities, including cardiovascular disease, psoriatic arthritis and metabolic syndrome.3–6 These physical and other psychological comorbidities2 impair health-related quality of life (HRQoL).7
Guidelines recommend the topical use of corticosteroids and vitamin D3 analogs as first-line treatment for psoriasis, either as separate products (used in combination) or as a fixed combination treatment.8,9 The vitamin D3 analog calcipotriene and the corticosteroid betamethasone dipropionate in fixed combination formulations have superior efficacy compared with their individual components.10,11 In addition, the fixed combination has a more favorable tolerability profile versus monotherapy as local skin reactions typically associated with calcipotriene treatment appear to be attenuated by the addition of betamethasone dipropionate. Additionally, the presence of calcipotriene may increase the steroid effect within the combination, without compromising the tolerability profile.10 The once-daily fixed combination also offers improved convenience over the twice-daily applications required for the respective monotherapies,12 which can improve adherence.13 Topical suspension and ointment formulations of this fixed combination (Taclonex®/Daivobet®/Dovobet®) are established first-line treatments for psoriasis vulgaris.14