Abstract
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.
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Acknowledgements
The authors would like to acknowledge Yuri Sankawa for medical writing support that was funded by LEO Pharma in accordance with Good Publications Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
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Acknowledgement and disclosures. Ethics statement: All patients provided written informed consent. The research complies with the guidelines for human studies and animal welfare regulations. Approval of the study protocol was obtained from an independent ethics committee (Freiburger Ethikkommission GmbH International). The study was conducted in accordance with the World Medical Association Declaration of Helsinki, and local ethical and legal requirements, such as the guidelines and recommendations of the German Association of Research-based Pharmaceutical Companies (Verband Forschender Arzneimittelunternehmen, VFA) to improve the quality and transparency of non-interventional studies (NIS), the joint recommendations of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), and the Paul Ehrlich Institute on planning, conducting and evaluation of post-marketing surveillance studies, as well according to the code of conduct of the Registered Society for Medicinal Products and Cooperation in the Health Sector (Verein Arzneimittel und Kooperation im Gesundheitswesen, AKG e. V.). Financial support: This study was supported by LEO Pharma GmbH, Germany. Conflicts of interest: Thomas Diepgen has received honoraria and travelling expenses as consultant and lecturer for LEO Pharma. Christoph Eicke was commissioned by LEO Pharma GmbH for the management of this study. Mike Bastian is an employee of LEO Pharma GmbH. Data management and statistical analyses were performed by Anfomed GmbH, Möhrendorf, Germany.
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Diepgen, T.L., Eicke, C. & Bastian, M. 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. Eur J Dermatol 29, 401–408 (2019). https://doi.org/10.1684/ejd.2019.3603
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DOI: https://doi.org/10.1684/ejd.2019.3603