Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies
August 2016 | Volume 15 | Issue 8 | Original Article | 951 | Copyright © August 2016
Linda Stein Gold MD,a Mark Lebwohl MD,b Alan Menter MD,c John Villumsen MSc,d Monika Rosen PhD,d and John Koo MDe
aHenry Ford Health System, Detroit, MI
bIcahn School of Medicine at Mount Sinai, New York, NY
cMedical Center, Baylor University, Dallas, TX
dLEO Pharma A/S, Ballerup, Denmark
eUniversity of California, San Francisco, CA
Abstract
BACKGROUND: Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this formulation for 4 weeks of treatment.
METHODS: Patients aged ≥18 years with mild–severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity (‘treatment success’); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).
RESULTS: 1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: –30 mm), maintained to week 4 (change in itch VAS: –41 mm).
CONCLUSIONS: Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.
J Drugs Dermatol. 2016;15(8):951-957.
INTRODUCTION
Psoriasis vulgaris is a chronic inflammatory disease1,2 with an impact on patient quality of life (QoL) comparable to other chronic diseases, such as cardiovascular disease and type 2 diabetes.3 Most patients with mild-to-moderate psoriasis vulgaris (plaque psoriasis) manage their disease with topical therapies, commonly using formulations containing corticosteroids and/or vitamin D3 analogs.4 The vitamin D3 analog calcipotriene 0.005% (Cal) together with the corticosteroid betamethasone dipropionate 0.064% (BD) have been developed in a fixed combination. Ointment and topical suspension formulations of Cal/BD fixed combination have superior efficacy and improved tolerability compared with the individual active ingredients5,6 and are established first-line treatments for psoriasis.7 An innovative alcohol-free
aerosol foam formulation of Cal/BD, which has greater in vitro drug penetration than Cal/BD ointment,8 has been developed with the hope that this new formulation will further increase the therapeutic options available to patients by enhancing adherence, thus improving treatment of psoriasis vulgaris.
Phase II and Phase III clinical trials have now been completed and have demonstrated that Cal/BD aerosol foam is more effective than Cal/BD ointment and gel formulations, as well as the individual active ingredients, with a favorable safety profile.9-14 Data from three trials, which all had the same inclusion criteria, have been pooled to increase the precision in the estimate of the effect size and confirm the efficacy and tolerability profile of Cal/BD aerosol foam. In this pooled analysis, we evaluated
