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| |  Aldara (Imiquimod) Safe, Effective For Treatment of External Genital Warts LONDON, ENGLAND -- December 12, 2001 -- New findings from a recent, international,open-label study reaffirm that the patient-applied treatment, Aldara™ (imiquimod) Cream, 5%, is safe and effective for eradicating external genital warts -- the results of which are reflective of a real-life clinic setting.(1) The study reports that the efficacy of Aldara in 943 male and female patients of different ethnic backgrounds was similar to that in previous randomized, vehicle-controlled studies, according to the International Journal of STD & AIDS. (1),(2),(3) This international trial is the first published study that investigates the efficacy of a topical therapy for external genital warts in such a large group of patients -- in 114 clinics across five continents (Europe, Canada, Latin America, Australia and South Africa).(1) Patients whose warts decreased in size but did not totally clear in the initial 16 weeks of therapy (191, 20 percent), were offered the option to apply Aldara for up to an additional 16 weeks. This resulted in total clearance in 33 percent of these patients. This continued application of Aldara was well-tolerated by patients, and this study highlights that the frequency of application site reactions was, indeed, lower in the second treatment cycle compared to the initial 16 weeks of therapy. Furthermore, the results of this study validate previous observations from the highly controlled trials that patients whose warts cleared with Aldara therapy, tended to remain clear.(2),(3) "The fact that less than 10 percent of the patients required re-treatment in the three months after their warts cleared, is a considerable advantage of this cream compared to many of the other genital wart treatments that are available," comments lead author Dr. Suzanne Garland, Department of Microbiology and Infectious Diseases, Royal Women's and Royal Children's Hospitals, Victoria, Australia. For patients whose warts did return, doctors advised them to apply Aldara for up to an additional 16 weeks. This was reported to be as equally effective as when Aldara was first applied, with total clearance observed in 70 percent of those patients.(1) A low rate of recurrence after treatment is an important factor in the successful management of external genital warts, as it is likely to decrease the number of clinic visits a patient makes for repeat treatment. Genital warts, caused by human papillomavirus, are one of the most common sexually transmitted diseases. By one estimate, at least 10 percent of sexually active adults in the US are infected with HPV, with perhaps 1-2 percent having genital warts.(4) The incidence of genital warts is greatest in young adults between 18 and 28 years of age.(1) Aldara, which can be applied by patients in the privacy of their home, is the first in a new class of drugs called immune response modifiers (IRM), which demonstrate in vivo antiviral and antitumor activity. The IRM's mode of action stimulates specific components of the host's own immune system, which act to eradicate the warts. Aldara is recommended as a first-line treatment option for external genital warts by guidelines from the Centers for Disease Control and Prevention (CDC), Latin America and Europe.(5),(6),(7) Aldara (imiquimod) Cream, 5%, is a prescription only medicine, which is currently licensed for the treatment of external genital warts. References: 1. Garland SM, Sellors JW, Wikstrom A, et al. Imiquimod 5% cream is a safe and effective self-applied treatment for anogenital warts -- results of an open-label, multicentre Phase III trial. Int J STD AIDS 2001;12:722-729. 2. Edwards L, Ferenczy A, Eron L, et al. Self-administered topical 5% imiquimod cream for external anogenital warts. Arch Dermatol 1998;134(1):25-30. 3. Beutner KR, Spruance SL, Hougham AJ, et al. Treatment of genital warts with an immune-response modifier (imiquimod). J Am Acad Dermatol 1998;38:230-9. 4. Koutsky LA. Epidemiology of genital human papillomavirus infection. Am J Med 1997:102(5A):3-8. 5. CDC 1998 Guidelines for treatment of sexually transmitted diseases. MMWR 1997;47:RR1. 6. Tatti S, Belardi G, Marini M, et al. Consenso en la Metodologia de Diagnostica y Terapeutica para las Verrugas Anogenitales. Revista Obstetricia y Ginecologia Latino-americanas. 2001;59(3):117-131. 7. von Krogh G, Lacey CJN, Gross, G et al. European course on HPV-associated pathology: Guidelines for the diagnosis and management of anogenital warts. Sex Trans Inf 2000;76:162-168.
SOURCE 3M Pharmaceuticals
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