Ingenol mebutate as topical treatment for actinic keratosis based on a prospective, non-interventional, multicentre study of real-life clinical practice in Germany: efficacy and quality of life

Background The use of ingenol mebutate (IM) as a field-directed therapy over a short period of time has been shown to be effective and well tolerated in randomized Phase III trials. Objectives To assess the efficacy and patient-reported outcomes for IM as treatment for actinic keratosis (AK) under daily "real-life" practice conditions. Materials and Methods A total of 826 adult patients with AK were enrolled by 292 dermatologists in Germany in a prospective, open, non-interventional, non-controlled, multicentre study. All patients were treated with IM and followed for eight weeks. Results The mean number of clinically visible AK lesions decreased significantly from 7.1 +/- 6.8 to 2.8 +/- 4.5 (p<0.0001). Most dermatologists (79.0%) rated global efficacy of IM as "very good"/"good" and 82.6% of the patients were "very satisfied" or "rather satisfied" with the efficacy of IM. Patient-reported outcomes showed greater efficacy and treatment comfort with IM compared to any last previous AK treatment with a comparable tolerability profile. Skin-related QoL data revealed a significant improvement of 50.2% after IM treatment (p<0.0001). Adverse events were reported in 7.0% of all patients, which were in most cases mild in intensity. Conclusion Field-directed treatment with IM over a short period was associated with a high level of treatment satisfaction, as reported by dermatologists and patients. This observational study demonstrates the effectiveness and tolerability of IM in everyday clinical practice in addition to the known efficacy and safety obtained by randomized controlled clinical trials.