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Comparative Study
. 2018 Apr;78(4):710-716.
doi: 10.1016/j.jaad.2017.12.042. Epub 2017 Dec 24.

A real-world, community-based cohort study comparing the effectiveness of topical fluorouracil versus topical imiquimod for the treatment of actinic keratosis

Romain Neugebauer  1 , Katherine A Levandoski  2 , Zheng Zhu  1 , Monica Sokil  1 , Mary-Margaret Chren  3 , Gary D Friedman  1 , Maryam M Asgari  4
Affiliations
Comparative Study

A real-world, community-based cohort study comparing the effectiveness of topical fluorouracil versus topical imiquimod for the treatment of actinic keratosis

Romain Neugebauer et al. J Am Acad Dermatol. 2018 Apr.

Abstract

Background: The most widely used topical agents for the field-based treatment of multiple actinic keratoses (AKs) are 5-fluorouracil and imiquimod, but their comparative effectiveness has not been assessed in a real-world setting.

Objective: We compared the effectiveness of 5-fluorouracil and imiquimod in reducing risk for subsequent AKs in a large, integrated health care delivery system in northern California.

Methods: In this cohort study, we identified adult health plan members who had an AK diagnosed in 2007 and who subsequently filled a prescription for 5-fluorouracil or imiquimod (N = 5700). We followed subjects for subsequent AKs identified by the International Classification of Diseases codes and estimated the 2-year (short-term) and 5-year (long-term) differences in cumulative risk while controlling for potential confounding by pretreatment variables.

Results: 5-Fluorouracil reduced the short-term incidence of subsequent AKs (cumulative risk difference -4.54% [95% confidence interval, -7.91% to -1.17%]), but there was no statistically significant evidence of a long-term decreased risk (cumulative risk difference -1.43% [95% confidence interval, -3.43% to 0.05%]) compared with that with imiquimod.

Limitations: This is a retrospective study with limited ascertainment of all relevant potential confounding variables.

Conclusion: We found that 5-fluorouracil appeared to be significantly more effective than imiquimod in the short-term, but not long-term, prevention of subsequent AKs.

Keywords: actinic keratosis; basal cell carcinoma; comparative effectiveness; keratinocyte carcinoma; skin cancer; squamous cell carcinoma.

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Conflict of interest statement

Conflicts of Interest Disclosure: Dr. Asgari has research contracts with Pfizer Inc. and Valeant Pharmaceuticals, which are not relevant to the contents of this manuscript.

Figures

Figure 1
Figure 1
Study flow diagram Flow diagram depicting the derivation of the study cohort.
Figure 2
Figure 2
Kaplan-Meier estimators (crude) Kaplan-Meier estimators showing the probability of subsequent actinic keratosis (AK) based on treatment type. The Kaplan-Meier estimators indicate a statistically significant reduction in risk of subsequent AK for 5-FU compared to imiquimod at 2 years but not at 5 years.
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