Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study

Abstract

Background: Acitretin is available for use in psoriasis since the late 1980s; however, there is no consensus on its optimum effective dose with acceptable side-effects.

Objective: To evaluate the efficacy and safety of acitretin in three fixed doses in adult patients with severe plaque type psoriasis.

Methods: This was a randomized, double blind, parallel group, dose ranging study. The study included patients of either gender (age range, 18-65 years) with severe chronic plaque type psoriasis. Of the 80 patients screened, 61 were randomly assigned to three groups: group A - 20 patients (acitretin 25 mg/day), group B - 20 patients (acitretin 35 mg/day) and group C - 21 patients (acitretin 50 mg/day) for 12 weeks. Forty-eight patients completed the study. The main outcome measure was change in Psoriasis Area Severity Index (PASI) score between the three groups from baseline to 12 weeks.

Results: After 12 weeks of therapy, the percentage reduction in the PASI score was 54%, 76% and 54% in acitretin 25, 35 and 50 mg/day group respectively. PASI 75 was achieved in 47%, 69% and 53% patients in acitretin 25, 35 and 50 mg/day groups respectively. The majority of adverse events were mucocutaneous, mild-to-moderate severity and dose dependent.

Conclusions: Acitretin 35 mg/day was observed to be more efficacious compared to 25 mg/day and 50 mg/day dosing, whereas its safety profile is better than 50 mg/day dosing in the management of severe plaque type psoriasis in adult patients.