Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris

Abstract

Background A two-compound ointment containing calcipotriol 50 lg g)1 and betamethasone dipropionate 0Æ5 mg g)1 has recently been shown to be an effective treatment for psoriasis. Objectives This study was designed to investigate efficacy and safety of different treatment regi mens with the two-compound product (Daivobet ⁄ Dovobet ; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 lg g)1 ointment (Daivonex ⁄ Dovonex ; LEO Pharma). Methods In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investiga tors’ global assessments of disease severity. The primary response criteria were percentage reduc tion in PASI and proportion of patients with absent ⁄ very mild disease according to the investigators’ global assessments after 8 weeks of treatment. Results The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73Æ3% for group 1, 68Æ2% for group 2 and 64Æ1% for group 3. The proportion of patients with absent ⁄ very mild disease at the end of 8 weeks of treatment was 55Æ3% for group 1, 47Æ7% for group 2 and 40Æ7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0Æ001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent ⁄ very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent ⁄ very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional ⁄ perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0Æ001): 10Æ9% in group 1, 11Æ5% in group 2 and 22Æ3% in group 3. Conclusions Two different short-term treatment regimens employing a recently developed two compound product (calcipotriol ⁄ betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris