A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet((R))/Daivobet((R))/Taclonex((R))) in the treatment of psoriasis vulgaris

• Published in: British journal of dermatology (1951) Vol. 154; no. 6; p. 1155
• Main Authors: Kragballe, K, Austad, J, Barnes, L, Bibby, A, de la Brassinne, M, Cambazard, F, Fleming, C, Heikkila, H, Jolliffe, D, Peyri, J, Svensson, Åke, Toole, J, Wozel, G
• Format: Journal Article
• Language: English
• Published: 01.06.2006
• Subjects: betamethasone dipropionate; calcipotriol; Clinical Medicine; controlled trial; Dermatologi och venereologi; Dermatology and Venereal Diseases; Klinisk medicin; Medical and Health Sciences; Medicin och hälsovetenskap; psoriasis; randomized; safety; two-compound product
• ISSN: 1365-2133
• DOI: 10.1111/j.1365-2133.2006.07236.x

The calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.