Ingenol mebutate for the treatment of actinic keratosis: effectiveness and safety in 246 patients treated in real-life clinical practice

Abstract

Introduction: The aim of the study was to evaluate the results on effectiveness and safety of topical treatment for actinic keratosis (AK) with ingenol mebutate gel (IMG) in real-life conditions and to perform an analysis of the factors that may influence the treatment outcomes.

Materials and methods: Retrospective study of patients with non-hyperkeratotic AK lesions prescribed with IMG in Spain according to clinical practice. Dermatologists reported the characteristics of patients and AK at baseline, and the findings observed up to 60 d after treatment.

Results and conclusions: A total of 260 treatments in 246 patients with a mean (SD) age 70.6 (10.4) years were reviewed. The number of clinically visible AK in the treated area decreased from 6.16 (3.02) to 1.22 (2.02) (p < .001) lesions with an average reduction of 84%. Univariate analysis showed higher reduction rates when IMG was applied in the face/scalp (p = .026), in women (p = .041), and in patients under 70 years of age (p = .033). According to multivariate analysis, advanced age was associated with worse clearance rates (p = .038). However, besides statistical significance, we can conclude that gender (female) and age (under 70 years-old) show a tendency to have better efficacy outcomes but without clinical relevance. Topical IMG was generally well tolerated and had positive cosmetic results after 60 d. Age influences on IMG effectiveness for AK and LSRs were correlated with higher effectiveness ratios.

Keywords:

• Actinic keratosis
• topical therapy
• ingenol mebutate gel
• skin cancer

Acknowledgments

The authors would like to acknowledge Jordi Amigó, of Clever Instruments, for medical writing support that was funded by LEO Pharma (Ballerup, Denmark).

Disclosure statement

Rafael Salido Vallejo served as an investigator for LEO Pharma A/S, Almirall and Roche; he has received speaker honoraria for Almirall, LEO Pharma A/S, Galderma, Biofrontera and Abbvie; he has attended advisory boards for Almirall and LEO Pharma A/S.

Rosa Ortega del Olmo served as investigator for LEO Pharma A/S; she has received speaker honoraria for LEO Pharma A/S; she has attended advisory boards for LEO Pharma A/S.

Additional information

Funding

For medical writing support that was funded by LEO Pharma (Ballerup, Denmark).