The use of ingenol mebutate to treat actinic keratosis in standard clinical practice: a prospective phase IV multicenter observational cohort study

Abstract

BackgroundActinic keratosis (AK) is a chronic, precancerous skin disease. Various treatments options exist, including ingenol mebutate gel. The aim of this study was to compare its effectiveness and tolerability as well as the impact of therapy on patients’ quality of life in standard clinical practice.MethodsA multicenter study was carried out involving a 12‐month follow‐up period. A sample of 440 patients was included. Medical history details were recorded. Effectiveness, compliance to treatment, quality of life (EQ‐5D‐5L), and treatment satisfaction questionnaire for medication (TSQM‐9) at week 8 were assessed.ResultsOf the total 440 patients, 428 (97.3%) attended at 8 weeks assessment. The number of patients with complete clearance was 337 (78.7%). EQ VAS score was significantly increased (P < 0.001). As far as TSQM‐9 is concerned, patients with complete clearance reported statistically significantly higher satisfaction in effectiveness, convenience, and global satisfaction. At the 12‐month follow‐up visit, 323 patients (95.8%) retained their clearance status. Nineteen patients did not apply the ingenol mebutate gel on consecutive days. For these patients, the complete clearance rate was 42.1%, while for those who were treated on consecutive days, the complete clearance rate was 80.6%. None of our patients developed skin cancer.ConclusionsThis study supports that ingenol mebutate is effective for the treatment of AK with a good safety profile. It significantly improves quality of life. Limited adherence to treatment might be associated with reduced effectiveness.

Patient‐reported outcomes of topical therapies in actinic keratosis: A systematic review

“…Adherence to the treatment was generally very high for shorter‐duration treatments, with few patients reporting treatment discontinuation due to side effects 6,8,10,12,13,15‐17,19,22‐26 …”

“…Only four studies were clinical trials. 10,[23][24][25] Investigations were designed prevalently as national studies (10/14) 6,8,10,12,[15][16][17]22,23,26 and carried out in North America, 10,15 Europe, 8,16,17,22,26 South America, 6,23 and Australia. 12 Brazil was the only represented South American country, 6,23 and no data were present to represent Asian and African countries.…”

“…6,22,24 5% to 57.9% of patients had a previous history of skin cancer, while 19.3% to 90.3% had been previously treated for AK. 6,8,10,12,13,[15][16][17]19,[22][23][24][25][26] The majority of the patients belonged to Fitzaptrick's skin phototypes I and II. In relation to satisfaction regarding the adverse effects, the group treated with DFS showed higher satisfaction compared to the group treated with 5-FU, with 93.3% and 38.4% of highly satisfied patients, respectively.…”

“…Health Questionnaire-4 (PHQ-4) 8 , EuroQoL 5-level EQ-5D version (EQ-5D-5L), 13,26 EuroQol Visual Analogue Scale (EQ-VAS), 13,26 and Dermatology Life Quality Index (DLQI). 24 Four studies utilized ad-hoc, non-validated questionnaires.…”

“…24 Four studies utilized ad-hoc, non-validated questionnaires. 6,10,12,23 Five studies utilized only one PRO (ad-hoc questionnaire 6,12,23 vs validated questionnaire 11,15 ), while 11 studies used more than one PRO instrument (only validated questionnaires 13,17,19,[24][25][26] vs validated and not validated questionnaires 8,10 ).…”