Quality of life in treatment of AK: Treatment burden of ingenol mebutate gel is small and short lasting

Abstract

Background: Treatments for actinic keratosis (AK) can elicit adverse local skin responses (LSRs). Knowledge regarding the burden of AK treatment on health related quality of life (HRQoL) is however limited. Objectives: To investigate whether treatment of AK improved HRQoL; to assess whether LSRs had an impact on HRQoL during treatment and to analyze the relationship between LSRs and HRQoL. Methods: Patients (n = 329) were randomized for treatment with cryosurgery (CRY) followed by ingenol mebutate (IngMeb) (CRY + IngMeb) or CRY followed by vehicle (CRY + vehicle). HRQoL was analyzed using DLQI, EQ-5D and EQ-VAS at baseline, three days, two weeks and eight weeks post treatment. Results: Statistically significant HRQoL improvements were seen in all measures in both treatment groups (p < 0.001). Impairments in DLQI in CRY + IngMeb at LSR peak were within a range interpreted as having “a small impact on patients’ life” (2–5), which normalized within two weeks. Limitations: DLQI may not be sensitive to change in the AK disease as it mainly captures symptoms and has a limited focus on feelings. Conclusion: The treatment burden of IngMeb is small, manageable and short-lasting. Since AK is a chronic condition, often requiring repeated treatment courses, combining treatments that provide enhanced effectiveness, while limiting HRQoL impairment is essential.

Keywords:

• Actinic keratosis
• ingenol mebutate gel
• health related ouality of life
• DLQI
• EQ-5D
• local skin responses

Acknowledgements

Editorial support for the manuscript was provided by Dr. V. Wolfram, and E. Farrington of Adelphi Values.

Disclosure statement

Jenny M. Norlin, Kim Mark Knudsen and Thomas Larsson are employes at LEO Pharma A/S. Stephen Stone, C. William Hanke are not conflicted.

Funding information

This work was funded by LEO Pharma A/S.