Patient-Reported Outcomes in Topical Field Treatment of Actinic Keratosis in Swedish and Danish Patients

Norrlid H, Norlin J, Holmstrup H, Malmberg I, Sartorius K, Thormann H, Jemec G B.E. and Ragnarson Tennvall G

Topical treatments in dermatology are often long and complex which often lead to non-adherence and non-persistence to prescribed treatment regimens. Clinical efficacy in clinical practice may thus not reached the levels in randomized clinical trials (RCT), where treatments are evaluated when given under strict and controlled conditions. Observational studies, in real-world settings, may therefore provide further insight in the real-world benefits of topical treatments in dermatology.
This study analyses patient-reported treatment adherence, treatment satisfaction and health-related quality of life (HRQoL) with topical treatments of actinic keratosis (AK) in routine clinical practice in Denmark and Sweden.

For this purpose, questionnaire data from the RAPID-ACT study was analysed. The study subjects consisted of adult patients who were prescribed field-directed topical AK treatment with diclofenac gel, imiquimod or ingenol mebutate per routine clinical practice. Collected data included validated instruments to measure treatment satisfaction (TSQM-9), treatment adherence (MMAS) and HRQoL (EQ-5 D-5 L, EQ-VAS, AKQoL).

In total, 446 patients from Denmark and Sweden were included. Ingenol mebutate patients (n=259) reported a higher satisfaction with treatment effectiveness than patients treated with diclofenac (n=40; p=0.006). Self-reported treatment adherence was generally high in all treatment groups, but higher for ingenol mebutate compared to both diclofenac (p<0.001) and imiquimod (n=147; p=0.007). This may be explained by the shorter treatment duration and/or the less complex treatment scheme and may lead to improved treatment outcomes. However, no differences between treatment groups in terms of HRQoL improvement from treatment initiation to end of treatment.

The lack of HRQoL-advantages for ingenol mebutate, despite superior treatment adherence, may be related to a relatively short follow-up period. Therefore, the authors propose additional research regarding the link between treatment adherence and real-world effectiveness.

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Journal of Dermatological Treatment, 2018;29(1):68-73