Objectives: Clinical experience favors low doses of acitretin to reduce adverse events but still maintain efficacy. We revisited the pivotal acitretin trials to compare the efficacy of high- versus low-dose acitretin.
Materials and methods: We analyzed data from two large randomized trials which had an 8-week, double-blinded (DB), placebo-controlled phase followed by a 16-week open-label (OL) phase. During the DB phase, patients received placebo, 10, 25, 50, or 75 mg of acitretin daily. Dose adjustment was allowed during the OL phase, during which high-dose treatment was defined as approximately 50 mg/day and low-dose as approximately 25 mg/day. Primary end points were improvement of psoriasis based on investigator static global assessment (ISGA) and reduction in affected body surface area (BSA).
Results: At the end of the OL phase (week 24), treatment success rates were similar among all groups (29%-33%)--with the exception of the group receiving low-dose treatment for both DB and OL phases (47% success). Decrease in BSA was also highest in this group (73% vs. 28% to 54%).
Conclusion: Individualization of acitretin dosing is crucial to minimize side effects and should lead to improved adherence and efficacy. This analysis supports the utility of low-dose acitretin for psoriasis over extended treatment periods.