Efficacy and safety of fixed-dose combination calcipotriol/betamethasone dipropionate foam for the treatment of psoriasis.

Abstract

The fixed-dose combination calcipotriol (Cal; 50µg/g) plus betamethasone dipropionate (BD; 0.5mg/g) ointment and gel formulations have well-established efficacy profiles in the treatment of psoriasis vulgaris (chronic plaque psoriasis); this combination has been shown to produce favourable outcomes versus either monotherapy. To improve upon the efficacy and cosmetic acceptability of these treatments Cal/BD foam was developed, demonstrating superior efficacy in Phase II/III studies compared with either of its monocomponents, Cal/BD ointment, Cal/BD gel and various other therapies for the treatment of psoriasis. Multiple outcome measures were evaluated in the clinical studies, including physician's global assessment of disease severity and modified psoriasis area and severity index. Of note, 38-55% of patients across studies achieved a physician's global assessment of 'clear' or 'almost clear' after 4weeks of Cal/BD treatment. This superior efficacy was not associated with an increased frequency or severity of adverse events, and there was no evidence for dysregulation of the hypothalamic-pituitary-adrenal axis or calcium homeostasis. Overall, Cal/BD foam was efficacious, with a good tolerability profile consistent with established Cal/BD formulations.