IMIQUIMOD, A PATIENT-APPLIED IMMUNE-RESPONSE MODIFIER FOR TREATMENT OF EXTERNAL GENITAL WARTS

Genital human papillomavirus infection is one of the most common sexua lly transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. The present prospective, mult icenter, double-blind, randomized, vehicle controlled trial evaluated the efficacy and safety of daily patient-applied imiquimod for up to 1 6 weeks for the treatment of external genital warts. Wart recurrence w as investigated during a 12-week treatment-free follow-up period. In t he intent-to-treat analysis, baseline warts cleared from 49 of 94 (52% ) patients treated with 5% imiquimod cream, 13 of 90 (14%) patients tr eated with 1% imiquimod cream, and 3 of 95 (4%) vehicle-treated patien ts; the differences between the groups treated with vehicle and imiqui mod were significant (P < 0.0001). For subjects who completed the foll ow-up period, recurrence rates after a complete response were 19% (9 o f 48 patients) in the 5% imiquimod cream group, 17% (2 of 12) in the 1 % imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (gene rally of mild or moderate severity) were common, particularly in the 5 % imiquimod cream group. Local reactions caused two patients to discon tinue treatment. The most frequently reported local skin reactions wer e erythema, excoriation or flaking, and erosion. Patient-applied 5% im iquimod cream is effective for the treatment of external genital warts and has a favorable safety profile.