Predictors of outcomes and satisfaction with tirbanibulin in actinic keratosis: a multicenter real-world study

Background: Tirbanibulin 1% ointment is a short-course field therapy for actinic keratosis (AK). Real-world data on predictors of response, tolerability, and satisfaction may support patient selection and counselling. The aim was to evaluate effectiveness and tolerability in a large multicenter cohort, identify predictors of high clinical clearance and local skin reactions (LSRs), and describe patient and physician satisfaction. Methods: This retrospective observational real-life study (33 Italian dermatology centers) included 679 patients. Clinical response was classified as complete (100%), good (75-99%), moderate (50-74%), or <50% clearance; high clearance was defined as ≥75%. AK severity was assessed using AK Area and Severity Index (AKASI). LSRs were graded 0-4, and a total score was calculated. Satisfaction was rated 0-4 (scores 3-4 indicated high satisfaction.) Multivariable logistic regression identified predictors of high clearance, erythema, and vesiculation/pustulation. Results: Patients were predominantly male (70.8%), mean age 74.9±9.7 years; 77.6% were AK-experienced. All patients completed treatment. High clearance occurred in 69.7% and was greater in AK-naïve patients (78.3% vs. 67.1%, P<0.001). Mean AKASI decrease was 63.2%; photodamage improvement was 30.5%. Tolerability was favorable (mean LSR score 0.65±0.90); 11.9% of LSRs were ≥3, with no grade 4 vesiculation/ulceration occurring. Lower Olsen grade independently predicted high clearance. Female sex and age ≥75 years were associated with higher odds of selected LSRs. High satisfaction was reported by 79.4% of patients and 83.1% of physicians. Conclusions: Tirbanibulin 1% achieved high clearance with favorable tolerability and satisfaction, supporting its use in individualized management of field cancerization.