Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study
Por:
Reich, K, Zschocke, I, Bachelez, H, de Jong, EMGJ, Gisondi, P, Puig, L, Warren, RB, Mrowietz, U
Publicada:
1 jun 2015
Resumen:
BackgroundPsoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients.
ObjectiveBlinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/betamethasone dipropionate topical gel after 8weeks of once daily treatment in a large patient population.
MethodsIn this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8weeks preceding study participation, are followed over 64weeks. During the first 8weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ).
Results1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments.
ConclusionResults of this blinded interim analysis indicate that the fixed combination of calcipotriol/betamethasone dipropionate gel is highly efficacious and preferred by the majority of analysed patients.
Filiaciones:
Reich, K:
Dermatologikum Hamburg, Hamburg, Germany
Zschocke, I:
SCIderm GmbH, Hamburg, Germany
Bachelez, H:
Univ Paris Diderot, Hop St Louis, AP HP, Sorbonne Paris Cite,Dept Dermatol, Paris, France
de Jong, EMGJ:
Radboud Univ Nijmegen, Med Ctr, NL-6525 ED Nijmegen, Netherlands
Gisondi, P:
Univ Verona, Dermatol & Venerol Sect, I-37100 Verona, Italy
Puig, L:
Univ Autonoma Barcelona, Dept Dermatol, Hosp Santa Creu & St Pau, E-08193 Barcelona, Spain
Warren, RB:
Univ Manchester, Manchester Acad Hlth Sci Ctr, Dermatol Ctr, Salford Royal NHS Fdn Trust, Manchester, Lancs, England
Mrowietz, U:
Univ Klinikum Schleswig Holstein, Psoriasis Zentrum, Abt Dermatol Venerol & Allergol, Kiel, Germany
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