Immune response modifiers: imiquimod

Abstract

This large double-blind, random allocation, vehiclecontrolled trial aimed to investigate the efficacy and adverse effects of the new immune response modifier, imiquimod 5 per cent cream (Aldara), in the topical treatment of anogenital warts for up to 16 weeks. Results of the intention to treat analysis showed 50 per cent of patients who received imiquimod cream had complete clearing of all treated baseline warts, compared with 11 per cent of patients on vehicle (P 0.0001). Similarly, in the treatment failures analysis, imiquimod-treated warts cleared completely in 56 per cent of the treated group and in 14 per cent of the vehicle group (P 0.0001). A 12-week follow-up of those patients whose warts had completely cleared showed a baseline wart recurrence rate of 13 per cent in imiquimod patients and 10 per cent in vehicle. These findings indicate topical imiquimod 5 per cent cream, applied overnight at home three times each week, is an effective treatment, with acceptable side effects and a low recurrence rate compared with most other treatments. The cream formulation greatly enhances access to otherwise difficult to reach external genital warts.