Retrospective assessment of PASI 50 and PASI 75 attainment with a calcipotriol/betamethasone dipropionate ointment.

Author(s): Anstey AV, Kragballe K

Affiliation(s): Royal Gwent Hospital, Newport, Wales, UK, and Marselisborg Center, Aarhus University Hospital, Arhus C, Denmark. alex.anstey@gwent.wales.nhs.uk

Publication date & source: 2006-08, Int J Dermatol., 45(8):970-5.

Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial

BACKGROUND: The US National Psoriasis Foundation recently recommended that PASI 50 and PASI 75 response rates be used in clinical trials to enable comparisons across studies of different psoriasis therapies. To date, these response rates have not been reported for the two-compound ointment containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark). Further, in order to compare Daivobet with other therapeutics recently presented to the European regulatory authorities and the FDA, comparison with the biologicals, efalizumab, etanercept and alefacept, were also made. OBJECTIVES: To present the PASI 50 and PASI 75 results for the two-compound ointment containing calcipotriol and betamethasone dipropionate. METHODS: Data from six phase III studies conducted with the two-compound ointment were pooled and the PASI 50 and PASI 75 response rates calculated for patients with severe (PASI>or=17) or less severe disease (PASI<17) at treatment commencement. Results for the biological therapies, efalizumab, etanercept and alefacept, were obtained from relevant published phase III studies. RESULTS: PASI 50 and PASI 75 were achieved by more patients treated with the two-compound ointment than with the individual components. In patients with severe disease, the PASI 50 response rate after 4 weeks' treatment was 88.8% with the two-compound ointment, 69.2% with betamethasone dipropionate, 53.8% with calcipotriol, and 30.0% with ointment vehicle. In comparison, 12 weeks' treatment with the biologicals resulted in PASI 50 response rates of 59% with efalizumab, 74% with etanercept, and 56% with alefacept. CONCLUSIONS: The two-compound ointment is effective, producing a PASI 50 and PASI 75 response in greater than 80% and 50% of patients, respectively, regardless of psoriasis severity.