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Calcipotriol/Betamethasone Has Good Safety Profile in Psoriasis Vulgaris: Presented at EADV

By Jill Stein

RHODES, GREECE -- October 10, 2006 -- Treatment with an ointment that contains calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g (Daivobet/Dovobet/Taclonex) is safe in patients with psoriasis vulgaris.

Adverse effects primarily involved local mild skin reactions, the investigators reported here on October 7^th at the 15^th Congress of the European Academy of Dermatology and Venereology (EADV).

Kim Papp, MD, director of research, Probity Medical Research, Waterloo, Ontario, Canada, presented pooled safety data from 7 randomised, double-blind, vehicle- and/or active controlled studies of the combination product applied once or twice daily. Overall, 7,279 patients were included in the analysis.

Subjects were adults with psoriasis vulgaris that affected the trunk and/or limbs and was considered amenable to topical therapy. Control subjects received either betamethasone dipropionate or calcipotriol monotherapy. Treatment lasted from 4 to 12 weeks.

There were fewer reported adverse events in the calcipotriol/betamethasone dipropionate ointment group than in the vehicle (P = .005) and calcipotriol (P < .001) groups.

Most adverse events were mild in all treatment groups, but a higher percentage of adverse events were rated as mild in the 2-compound ointment group. The lowest percentage of severe adverse effects was reported in the 2-compound ointment group.

Lesional/perilesional side effects were reported by 8.7% of patients in the 2-compound ointment group, 16.2% in the vehicle group, 13.1% in the calcipotriol group, and 7.3% in the betamethasone dipropionate group.

The median time from treatment start to a lesional/perilesional side effect was 7 days in the 2-compound ointment group, 3 days in the vehicle group, 7 days in the calcipotriol group, and 5 days in the betamethasone dipropionate group.

Serious adverse effects were infrequent in all treatment groups, and most serious adverse effects were considered unrelated to the study treatment.

Rates of premature withdrawal from treatment due to an adverse effect were 0.7% in the calcipotriol/betamethasone dipropionate ointment group, 3.4% in the vehicle group, 2.5% in the calcipotriol group, and 0.6% in the betamethasone dipropionate group.

Local adverse events that were possibly steroid-related were reported at low and similar frequencies in the 2-compound ointment group and the active comparator groups.

Skin atrophy was reported by 0.1% of patients in the 2-compound product group compared with 0.2% for the vehicle, 0.1% for calcipotriol, and 0.2% for betamethasone dipropionate.

Dr. Papp said the results demonstrate that the 2-compound ointment has a favourable benefit-risk profile and is a useful treatment option for patients with psoriasis vulgaris of all levels of severity.

Psoriasis is a common disease that affects 1.3% of the general population. About 75% of patients can be managed with topical therapies such as vitamin D analogues and corticosteroids.

The study was sponsored by LEO Pharma.


[Presentation title: Pooled Safety Data for a Calcipotriol/Betamethasone Dipropionate Two-Compound Product in the Treatment of Psoriasis Vulgaris. Abstract P035.108]

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