THE EFFECT OF ADDITION OF CALCIPOTRIOL OINTMENT (50 MU-G G) TO ACITRETIN THERAPY IN PSORIASIS/

Our purpose was to find out whether the addition of calcipotriol ointm ent (50 mu g/g) to systemic treatment with acitretin produces addition al therapeutic effects and thereby an acitretin-sparing effect, and fu rther to investigate the safety and tolerability of this combination, A multicentre, randomized, double-blind placebo-controlled study was d esigned. Patients were randomized to receive calcipotriol or placebo. All patients were treated with a starting dose of 20 mg acitretin per day and doses were adjusted at 2-weekly intervals with increments of 1 0 mg per day up to a maximum of 70 mg per day. The dose requirement fo r acitretin, clinical signs and adverse events were recorded. Seventy- six patients were randomized to treatment with calcipotriol 50 mu g/g ointment twice daily and 59 patients to treatment with the vehicle onl y twice daily, Clearance or marked improvement was achieved by 67% of the patients in the calcipotriol group and by 41% of the patients in t he placebo group (P = 0.006). Calcipotriol treatment proved to have a statistically significant additional effect to acitretin on the Psoria sis Area and Severity Index, redness, thickness and scaliness as compa red with placebo. Clearance or marked improvement was achieved with a statistically significantly lower cumulative dose of acitretin by the patients in the calcipotriol group as compared with the placebo group. The number of patients reporting adverse events was pronounced and la rgely related to acitretin. No significant differences were observed b etween the two treatment groups with respect to adverse events. Labora tory assessments were essentially normal, The addition of calcipotriol ointment to acitretin treatment contributes to the efficacy, reduces the cumulative dose of acitretin to reach marked improvement or cleara nce, and is well-tolerated and safe.