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Evaluation of the Effectiveness of Imiquimod and 5-Fluorouracil for the Treatment of Actinic Keratosis: Critical Review and Meta-analysis of Efficacy Studies

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Journal of Cutaneous Medicine and Surgery

Abstract

Background:

Actinic keratosis lesions occur frequently on sun-exposed skin of Caucasians. They become more prevalent with advancing age and are important in identifying the risk factor of those people possibly predisposed to invasive squamous cell carcinoma. Topical therapies are useful alternatives to cryotherapy for treating diffuse actinic damage and a number of preparations have been developed for treating actinic keratosis.

Objectives:

A cumulative meta-analysis was performed to determine the efficacy of imiquimod 5% cream, which presents a new alternative topical therapy for actinic keratosis, and to compare it to 5-fluorouracil for the treatment of actinic keratosis lesions of the face and scalp.

Methods:

We searched MEDLINE (1966 to October 2004) for relevant studies evaluating the efficacy of actinic keratosis topical agents imiquimod and 5-fluorouracil (0.5%, 1%, and 5%). Studies included in this meta-analysis required a dosage regimen that was not significantly different from that approved by Health Canada and the U.S. FDA. Studies also required a well-defined treatment duration and followup period, with the primary efficacy variable being the complete (100%) clearance of all actinic keratosis lesions defined as the proportion of patients at followup with no clinically visible lesions in the treatment area. To determine the average efficacy rate for both drugs, the data from each study were combined for that drug.

Results:

Ten studies were included in the analysis. The average efficacy rate for each drug (with 95% confidence interval) was 5-fluorouracil, 52 ± 18% (n = 6 studies, 145 subjects) and imiquimod, 70 ± 12% (n = 4 studies, 393 subjects).

Conclusions:

The results of this meta-analysis show that both imiquimod and 5-fluorouracil are effective methods for the treatment of actinic keratosis and provide a useful alternative to cryotherapy. However, this analysis suggests that imiquimod may have higher efficacy than 5-fluorouracil for actinic keratosis lesions located on the face and scalp and therefore provides another option to dermatologists.

Antécédents:

L’apparition de lésions de kératose actinique sur la peau de sujets blancs est fréquente après l’exposition au soleil. Avec l’âge, ces lésions qui deviennent plus. répandues sont importantes dans 1’identification des facteurs de risque chez les sujets qui seraient prédisposes à être victimes d’une invasion de careinomes squameux. Les thérapies topiques sont des alternatives utiles à la cryotherapie dans le traitement des lésions actiniques diffuses. Un nombre de produits formulés ont êtê mis au point pour le traitement de la kératose actinique.

Objectifs:

Une méta-analyse cumulative a été effectuée en vue de déterminer 1’efficacité de la crème d’imiquimod à 5%, qui représente une nouvelle therapie topique alternative de la kératose actinique, et de la comparer à 5-fluorouracil dans le traitement des lésions de kératose actinique sur le visage et le cuir chevelu.

Méthodes:

Nous avons cherché dans MEDLINE (de 1966 jusqu’à octobre 2004) les études pertinentes qui évaluent l’efficacité des agents topiques imiquimod et 5-fluorouracil (0.5%, 1%, et 5%) dans le traitement des kératoses actiniques. Les études dont la présente méta-analyse tient compte suivent un dosage peu différent du dosage approuvé par Sante Canada et la FDA aux États-Unis. Les études doivent également comprendre une durée de traitement bien définie et une période de suivi. La principale variable d’efficacité est 1’épuration totale de la peau (100%) de toutes les lésions actiniques, définie comme la proportion de patients qui, au suivi, ne présentait aucune trace de lésions dans la zone traitée. Afin de déterminer le taux d’efficacité moyen de chacun des deux médicaments, les données de chaque étude ont été combinées.

Résultats:

Dix études ont été comprises dans 1’analyse. Le taux d’efficacite moyen de chaque médicament (avec un intervalle de confiance de 95%) est:5-fluorouracil, 52 ± 18% ( n = 6 études, 145 sujets) et imiquimod, 70 ± 12% (n = 4 etudes, 393 sujets).

Conclusion:

Les résultats de cette méta-analyse montrent que l’imiquimod et 5-fluorouracil sont tous deux efficaces dans le traitement des kératoses actiniques et représentent des alternatives utiles à la cryothérapie. Toutefois, cette étude suggère que l’imiquimod serait plus efficace que 5-fluorouracil dans le traitement des lésions de kératose actinique qui se trouvent sur le visage et le cuir chevelu, et représenterait done une autre option de traitement pour les dermatologues.

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Author information

Authors and Affiliations

  1. Division of Dermatology, Department of Medicine, Sunnybrook and Women’s College Health Science Center (Sunnybrook site) and the University of Toronto, Toronto, Canada

    Aditya K. Gupta

  2. Mediprobe Research Inc., London, Ontario, Canada

    Aditya K. Gupta, Valerie Davey & Heather Mcphail

  3. Aditya K. Gupta, 645 Windermere Road, N5X 2P1, London, Ontario, Canada

    Aditya K. Gupta

Authors
  1. Aditya K. Gupta
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  2. Valerie Davey
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  3. Heather Mcphail
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Correspondence to Aditya K. Gupta.

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Supported in part by 3M Pharmaceuticals, London, Ontario, Canada.

Dr. Gupta has acted as an advisor and conducted clinical trials for 3M Pharmaceuticals, London, Ontario, Canada.

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Gupta, A.K., Davey, V. & Mcphail, H. Evaluation of the Effectiveness of Imiquimod and 5-Fluorouracil for the Treatment of Actinic Keratosis: Critical Review and Meta-analysis of Efficacy Studies. J Cutan Med Surg 9, 209–214 (2005). https://doi.org/10.1007/s10227-005-0148-6

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