Kragballe, K., Austad, J., Barnes, L., Bibby, A., de la Brassinne, M., Cambazard, F., Fleming, C., Heikkil, H., Jolliffe, D., Peyri, J., Svensson, Å., Toole, J., and Wozel, G.
Background The calcipotriol/betamethasone dipropionate two-compound product Dovobet®/Daivobet®/Taclonex®(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. Objectives 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. Methods 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. Results 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. Conclusions 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. [ABSTRACT FROM AUTHOR]