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
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.