Topical calcipotriol/betamethasone dipropionate achieves quicker response against psoriasis compared with biological therapies

October 1, 2006

An ointment containing calcipotriol (50mcg/g) plus betamethasone diproprionate (0.5mg/g) demonstrated significant efficacy against psoriasis within 4 weeks compared with 12 weeks of biological therapy, regardless of disease severity, as measured by the Psoriasis Area and Severity Index (PASI), according to a meta-analysis recently reported in the International Journal of Dermatology.

An ointment containing calcipotriol (50mcg/g) plus betamethasone diproprionate (0.5mg/g) demonstrated significant efficacy against psoriasis within 4 weeks compared with 12 weeks of biological therapy, regardless of disease severity, as measured by the Psoriasis Area and Severity Index (PASI), according to a meta-analysis recently reported in the International Journal of Dermatology.

PASI, used in clinical trials to measure psoriasis severity and treatment efficacy, is based on assessments of the affected body surface area, along with signs of disease (eg, erythema, desquamation, and induration). Recently, the US National Psoriasis Foundation Medical Advisory Board defined psoriasis treatment success as an improvement in PASI of at least 50% from baseline, referred to as the PASI 50. The PASI 50 is considered highly significant from a clinical and quality of life perspective for patients. Sometimes, an improvement in PASI of 75% or more (PASI 75) is reported. The board recommends reporting these 2 PASI values to facilitate comparisons of psoriasis therapies, both new ones and existing ones. PASI 50 and 75 rates for the 2-compound ointment had not been reported prior to this meta-analysis.

Calcipotriol/betamethasone dipropionate is available in the United States and abroad. To compare PASI 50 and 75 response rates for this topical treatment, pooled results from 6 international, randomized, double-blind, comparative studies of patients with chronic plaque psoriasis, each of 4 weeks' duration, were evaluated. The studies compared this combination therapy with therapy involving the individual components of the ointment and with placebo.

The calcipotriol/betamethasone dipropionate was topically administered once or twice daily for 4 weeks. Biological therapies were administered as follows: alefacept IV 7.5 mg/wk for 12 weeks; efalizumab 1.0 or 2.0 mg/kg/wk by subcutaneous (SC) injection for 12 weeks; or etanercept 50 mg by SC injection twice weekly for up to 24 weeks.

A total of 2,452 patients received calcipotriol/betamethasone dipropionate, 367 received alefacept, 1,172 received efalizumab, and 164 received etanercept.

After 4 weeks of treatment, PASI 50 was achieved in 88.8% of calcipotriol/betamethasone dipropionate patients with severe disease and in 83.0% of those with less severe disease (baseline PASI <17). PASI 75 was achieved in 54.1% of the 2-compound patients with severe disease and in 53.6% of the calcipotriol/betamethasone dipropionate patients with less severe disease.

The following PASI 50 rates were noted for patients with severe disease receiving the comparative topical therapies: 69.2%, 53.8%, and 30% (for betamethasone dipropionate only-, calcipotriol only-, and placebo-only treated patient, respectively-see Table 1). Corresponding PASI 50 results for patients with less severe disease were 63.7%, 48.2%, and 18.2%, respectively.

The results for the pooled analysis on the biological therapies in patients with moderate-severe chronic plaque psoriasis were determined at Week 12. The PASI 50 results were 56%, 59%, and 74% for alefacept, efalizumab, and etanercept, respectively. The corresponding PASI 75 results were 28%, 27%, and 49%, respectively.

Because these comparisons were not conducted in a head-to-head manner, some caution should be advised. Meta-analyses, however, often are used to make indirect comparisons of similar populations from comparable studies.

SOURCE Anstey AV, Kragballe K. Retrospective assessment of PASI 50 and PASI 75 attainment with a calcipotriol/betamethasone dipropionate ointment. Int J Dermatol. 2006;45:970–975.