Imiquimod 5% Cream is a Safe and Effective Self-Applied Treatment for Anogenital Warts — Results of an Open-Label, Multicentre Phase IIIB Trial

Abstract

Our objective was to determine the efficacy and safety of imiquimod 5% cream in the treatment of external genital/perianal warts in an open-label Phase IIIB trial. Patients applied imiquimod 5% cream 3 times per week, for up to 16 weeks. Those who cleared their warts were monitored during a 6-month follow-up period. If their warts recurred, or new warts developed during this time, patients could be re-treated for up to 16 additional weeks. Patients who experienced partial clearance during the initial treatment period entered an extended treatment period of up to an additional 16 weeks. A total of 943 patients from 114 clinic sites in 20 countries participated in this study. Complete clinical clearance was observed in 451/943 (47.8%) patients (intent-to-treat (ITT) analysis) during the initial treatment period, with clearance in an additional 52 (5.5%) patients during the extended treatment period beyond 16 weeks. The overall clearance rate for the combined treatment periods was 53.3%. In a treatment failure analysis, the overall clearance rate was 65.5%; a greater proportion of female patients (75.5%) experienced complete clearance than male patients (56.9%). Low recurrence rates, of 8.8% and 23.0%, were observed at the end of the 3- and 6-month follow-up periods, respectively. The sustained clearance rates (patients who cleared during treatment and remained clear at the end of the follow-up period) after 3 and 6 months were 41.6% and 33.0% (ITT analysis), respectively. Local erythema occurred in 67% of patients. In the majority of patients local skin reactions were of mild to moderate severity. In conclusion, imiquimod 5% cream is an effective self-applied treatment for external genital/perianal warts when applied for up to 16 weeks and is well tolerated for up to 32 weeks.

Advances in the use of topical imiquimod to treat dermatologic disorders

“…Complete wart clearance occurred in 52% of patients, with 19% wart recurrence at a 12-week follow-up. These results are similar to those obtained with 3 applications/week (Edwards et al 1998;Garland et al 2001). Therefore, 3 times per week treatment schedule is recommended because of a relatively lower rate of side effects (Perry and Lamb 1999;Gupta et al 2004;Chang et al 2005;Scheinfeld and Lehman 2006).…”

“…Its effi cacy in these disorders has been demonstrated in several RCTs (Beutner et al 1998;Edwards et al 1998;Perry and Lamb 1999;Garland et al 2001;Sauder et al 2003;Scheinfeld and Lehman 2006).…”

“…In an international open-label multicentre phase IIIB trial (Garland et al 2001) consisting of 943 patients from 114 clinic sites in 20 countries, IQ 5% cream was applied 3 times per week for up to 16 weeks with an overall complete clearance rate of nearly 48%. Recurrence rate at 6-months follow up was 23%.…”

CO₂ Laser Surgery for Extensive, Cauliflower-Like Anogenital Condylomata acuminata: Retrospective Long-Term Study on 19 HIV-Positive and 45 HIV-Negative Men

“…Imiquimod yields remission rates between 35 and 50% after 16 weeks of 3 times per week application [13, 14, 15]. More extensive and confluent lesions are commonly treated with high-frequency electrosurgery or CO 2 laser surgery.…”

Update on Genital Lesions

“…13 The newest therapy for genital warts involves the use of a topical immunomodulating agent, imiquimod, which up-regulates portions of the innate and adaptive immune systems, and ultimately leads to local secretion of antiviral interferon. 14,15 Although women respond somewhat better than men, complete *Kissing lesions are lesions appearing on adjacent skin areas and fixed-drug eruption is recurring lesion at same site each time offending drug administered.…”