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Meta-Analysis of AKs and Imiquimod
When it comes to topical treatment for actinic keratoses, imiquimod offers some pluses.
Prescription cream treatments for actinic keratoses (AKs) include 5-fluorouracil, diclofenac, and imiquimod. The authors of this meta-analysis evaluated short-term, randomized, double-blind, placebo-controlled trials of the efficacy and safety of imiquimod treatment for AKs. Of 19 identified published trials, the authors found 5 studies (with a total of 1293 subjects) that met the randomized-controlled criteria for inclusion. For the most part in these studies, AKs were diagnosed clinically; diagnosis was supplemented by biopsy in two studies. The trials lasted 12 to 16 weeks, with imiquimod or placebo applied 2 to 3 times per week.
The number needed to treat (NNT) for one patient to achieve complete clearance after 12 weeks of treatment was 2.2 (the lower the NNT, the better). For partial clearance, defined as 75% of lesions cleared, the NNT was 1.8. More imiquimod recipients than placebo recipients had adverse effects. Adverse events were local, and erythema, scabbing, and flaking were the most frequent. The number needed to harm (NNH) to produce one additional adverse event ranged from 3.2 to 5.9 (the higher the number, the better). Cause-related withdrawals occurred twice as often among imiquimod recipients as among placebo recipients. The NNT to cause one additional withdrawal was 20 (the higher, the better). No data were reported on withdrawals due to lack of efficacy. In one study, long-term follow-up demonstrated a recurrence rate of 10% after 12 months in imiquimod recipients. In a second study, recurrence rates in imiquimod recipients after 16 months were 25% in the 3x/week group and 43% in the 2x/week group.
Comment: In the treatment of actinic keratoses, imiquimod is similarly effective to 5-fluorouracil (reported NNT, 2.0) and about twice as effective as topical diclofenac (reported NNT, 3.7). As with other topical treatments, high rates of recurrence and new AK formation are to be expected. Because the local adverse-effect profiles of 5-fluorouracil and imiquimod are similar, many patients and physicians may still prefer a 2-week course of 5-fluorouracil over a 6-to-12-week course of imiquimod.
— George J. Hruza, MD
Published in Journal Watch Dermatology June 27, 2006
Citation(s):
Hadley G et al. Imiquimod for actinic keratosis: Systematic review and meta-analysis. J Invest Dermatol 2006 Jun; 126:1251-5.
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