Real-Life Treatment Profile of Calcipotriene and Betamethasone Dipropionate Topical Suspension in Patients With Psoriasis Vulgaris

November 2014 | Volume 13 | Issue 11 | Original Article | 1374 | Copyright © November 2014

Jerry Bagel MD FAAD,1 Eugenia Levi, PharmD BCPS,2 Stephen Tyring MD PhD FAAD,3
and Melissa L.F. Knuckles MD FAAD4

1Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
2LEO Pharma Inc, Parsippany, NJ
3Center for Clinical Studies, Department of Dermatology, University of Texas Health Science Center, Houston, TX
4PSC, Dermatology, Corbin, KY

Abstract
BACKGROUND: Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris.
AIM: To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs).
METHODS: In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient’s Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0–100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8.
RESULTS: After 8 weeks of treatment, DLQI score significantly improved compared with baseline (–5.5 ± 5.93; P<.0001), starting as early as week 2 (–4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (–19% ± 25.94%; P<.0001) and week 8 (–28.6% ± 29.14%; P<.0001). The percentage of patients with “controlled disease” (PtGA score of “clear” or “very mild”) was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients.
CONCLUSION: The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.

J Drugs Dermatol. 2014;13(11):1374-1379.

INTRODUCTION

Treatment with a fixed-combination topical suspension of calcipotriene plus betamethasone dipropionate has been shown in multiple randomized, controlled trials to be effective and well tolerated on the scalp and the body (ie, trunk and/or limbs) in patients with psoriasis vulgaris.1-5 Although randomized controlled trials play an important role in demonstrating the efficacy and safety of a therapeutic regimen, they often present unrealistically high estimates of patient-reported outcomes (PROs), including improvement in quality of life and treatment satisfaction.6 Noninterventional studies using real-life patient populations and capturing PROs can provide more realistic insights into patients’ experiences with treatment.
The treatment profile of the fixed-combination topical suspension of calcipotriene plus betamethasone dipropionate has not been well described in real-life clinical settings. The objective of this study was to document experience with this treatment in a US clinical dermatology practice setting using PROs, specifically, health-related quality of life (HRQoL), patient satisfaction, effect on itching, and control of psoriasis vulgaris.

MATERIALS AND METHODS

Study Design

This was an 8-week, prospective, noninterventional, one-arm, multicenter study in which patients were treated with the fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (CBD) topical suspension. Dermatologists prescribed CBD topical suspension in the manner consistent with their usual clinical practice and in accordance with the US label. Treatment could be discontinued prior to week 8 if the treatment area cleared. Treatment was reinitiated if lesions reappeared on the treatment area, as judged by the patient or investigator. More than one discontinuation and restart cycle was allowed.