Abstract
Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance studies have received little attention until now. Here, we systematically investigate interventions for AK from post-marketing surveillance trials as a proxy for real-world efficacy and tolerability. A systematic literature search was conducted in Medline, Embase, and CENTRAL. Pertinent trial registers were hand-searched until 25 March 2020. Results were pooled using a random-effects model to calculate pooled proportions and relative risks (RR) or were described qualitatively. Eleven records with a total sample size of n = 4109 were included. Three of the studies had an active-controlled design, while seven were single-armed. Participant complete clearance ranged from 23.1% for diclofenac sodium 3% gel to 88.9% for ingenol mebutate 0.05% gel. The lesion-specific clearance rate for photodynamic therapy (PDT) was 74% (95% confidence interval (CI) 56–87%). The recurrence rate was significantly higher for diclofenac sodium 3% in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02–1.1.8) and ranged from 10.6% for ingenol mebutate 0.015% gel to 23.5% for PDT. Few patients discontinued the trials due to adverse events. The results from the majority of the post-marketing surveillance studies deviated from those of pivotal trials.
Highlights
Actinic keratoses (AK) are common precancerous lesions attributable to lifelong exposure to ultraviolet (UV) radiation [1,2]
The remaining studies compared cryosurgery monotherapy with cryosurgery followed by diclofenac/HA [16], imiquimod 5% cream with diclofenac/HA [17], ingenol mebutate (IMB) 0.015% gel with diclofenac/HA [18], and one study investigated IMB 0.015% and 0.05% [20]
The results are important for patients with AK as well as treating physicians, as was recently demonstrated at the beginning of 2020 when the European Medicines Agency (EMA) recommended suspending the use of IMB because a post-marketing analysis revealed higher occurrence of non-melanoma skin cancer with IMB compared to imiquimod 5% cream (3.3% vs. 0.4%)
Summary
Actinic keratoses (AK) are common precancerous lesions attributable to lifelong exposure to ultraviolet (UV) radiation [1,2]. They belong to the most common skin lesions with a prevalence of up to 60% in Caucasians over the age of 60 years. AK possibly transform into invasive squamous cell carcinoma of the skin (cSCC) [1,2]. Despite recent advancements in the prognostic classification of AK, pertinent guidelines recommend early and consequent treatment of AK, because it is currently not possible clinically or histologically to exactly delineate whether and which lesions will transform into cSCC [3,4,5,6]
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