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Calcipotriol/Betamethasone Dipropionate

A Review of its Use in the Treatment of Psoriasis Vulgaris of the Trunk, Limbs and Scalp

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Abstract

Calcipotriol/betamethasone dipropionate (calcipotriol 50mg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D3 analogue and a corticosteroid indicated for the once-daily, topical treatment of psoriasis vulgaris of the trunk, limbs and scalp in adults. Both the ointment (Daivobet®; Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriol/ betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriol/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacological properties.

Calcipotriol/betamethasone dipropionate has low systemic absorption and displays local anti-inflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation.

In large, well designed clinical trials, calcipotriol/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4–8 weeks, was more effective than placebo, calcipotriol and tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriol/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp.

Long-term, once-daily, when required therapy with calcipotriol/betamethasone dipropionate for 52 weeks was more effective than calcipotriol alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriol for 48 weeks after 4 weeks of calcipotriol/betamethasone dipropionate or alternating between calcipotriol/betamethasone dipropionate and calcipotriol every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriol/betamethasone dipropionate also improved health-related quality of life.

Calcipotriol/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriol/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriol or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriol/ betamethasone dipropionate to be more cost effective than other topical therapies.

Thus, calcipotriol/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs and scalp.

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Authors and Affiliations

  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, Auckland, 0754, New Zealand

    Paul L. McCormack

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Correspondence to Paul L. McCormack.

Additional information

Various sections of the manuscript reviewed by: T.N. Dam, Department of Dermatology, Roskilde Hospital, Roskilde, Denmark; M. Kaufmann, Center for Biomedical Education and Research, Institute for Medical Biochemistry, The Protein Chemistry Group, University of Witten/Herdecke, Witten, Germany; R. Kaufmann, Department of Dermatology and Venereology, JW Goethe University, Frankfurt, Germany; R. Saraceno, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; G.A. Vena, 2nd Dermatology Clinic, University of Bari, Bari, Italy.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘calcipotriol/betamethasone dipropionate’ was identified by searching databases since 1985 (including MEDLINE and EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE search terms were (‘calcipotriol betamethasone dipropionate’ or ‘calcipotriene plus betamethasone’ or ‘calcipotriene/betamethasone plus calcipotriol’) and ‘psoriasis’. EMBASE search terms were ‘betamethasone dipropionate plus calcipotriol’ and ‘psoriasis’. AdisBase search terms were ‘calcipotriol/betamethasone dipropionate’ and ‘psoriasis’. Searches were last updated 11 March 2011.

Selection: Studies in patients with psoriasis vulgaris or scalp psoriasis who received fixed-dose combination calcipotriol/betamethasone dipropionate were selected. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Calcipotriol, betamethasone dipropionate, psoriasis vulgaris, scalp psoriasis, pharmacodynamics, pharmacokinetics, therapeutic use, pharmacoeconomics, tolerability.

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McCormack, P.L. Calcipotriol/Betamethasone Dipropionate. Drugs 71, 709–730 (2011). https://doi.org/10.2165/11207300-000000000-00000

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