Efficacy and safety of photodynamic therapy with amino-5-laevulinate nanoemulsion versus methyl-5-aminolaevulinate for actinic keratosis: A meta-analysis.

Abstract

Photodynamic therapy is an effective treatment for actinic keratosis. 5-aminolevulinic acid nanoemulsion (BF-200 ALA) and methyl-5-aminolevulinate (MAL) are both prodrugs for the treatment of actinic keratosis with photodynamic therapy. A comparison of the efficacy and safety between the drugs is critical for clinical practice. To investigate if photodynamic therapy in combination with BF-200 ALA is superior to photodynamic therapy with MAL for actinic keratosis. We performed a meta-analysis to investigate the combination of photodynamic therapy with BF-200 ALA and with MAL. The PubMed, Cochrane Library, Web of Science and EMBASE databases were searched to select eligible randomized controlled trials. Our search was conducted on April 1, 2019, and included the search terms "5-aminolevulinic acid nanoemulsion or BF-200 ALA", "methyl-5-aminolevulinate or methyl aminolaevulinate" and "actnic keratosis". Cochrane Risk of Bias Tool was used to estimate the risk of bias. The meta-analysis consisted of 5988 actinic keratosis lesions in five eligible randomized controlled trials, with a total of 2953 actinic keratosis lesions treated with BF-200 ALA and 3035 actinic keratosis lesions treated with MAL. BF-200 ALA in combination with photodynamic therapy showed significantly higher overall complete clearance rates (RR: 1.07, 95% CI 1.02-1.12, p = 0.01) and 3 month complete clearance rates (RR: 1.09, 95% CI 1.06-1.12, p < 0.00001) compared to MAL. A subgroup analysis was performed for photodynamic therapy combined with BF-200 ALA, revealing increased complete clearance rates of grade II-III lesions in comparison with MAL (RR: 1.24, 95% CI 1.05-1.46, p = 0.01). Compared with MAL, the pooled relative risk for the meta-analysis for recurrence was 0.67 (95% CI 0.48-0.92, p = 0.01) at 12 month after BF-200 ALA treatment. Photodynamic therapy with BF-200 ALA has a 9% better chance of complete clearance at 3 months and a 24% better chance of grade II-III lesions after treatment than with MAL for patients with actinic keratosis.