Andrea Carugno, Gianluca Nazzaro, Lisa Argnani, Francesco Bellinato, Elena Zappia, Maria V Masala, Giacomo Dal Bello, Mario Valenti, Giampaolo Addari, Giulia Ciccarese, Manfredo Bruni, Emanuele Trovato, Giovanni Paolino, Riccardo Balestri, Andrea D'Arino, Cristina Magnoni, Elisa Zavattaro, Giulia Toni, Roberta Giuffrida, Alice Verdelli, Stefano Caccavale, Alessia Villani, Serena Giacalone, Sebastiano Recalcati, Stefania Barruscotti, Stefano Bighetti, Luca Bettolini, Giovanni Fiorillo, Lerica Germi, Stefano Fazio, Carmen Cantisani, Vincenzo Maione, Salvatore D Infusino, Laura Eibenschutz, Alice Cesari, Martina Dragotto, Grazia B Zolo, Anna E Verzì, Paola Savoia, Iris Zalaudek, Elia Sala, Enzo Errichetti, Santo R Mercuri, Maria Esposito, Caterina Foti, Laura Atzori, Marco Ardigò, Francesco Lacarrubba, Maria Concetta Fargnoli, Pietro Danese, Simone Ribero, Paolo Gisondi, Angelo V Marzano, Nicola Zerbinati
Tirbanibulin 1% achieved high clearance with favorable tolerability and satisfaction, supporting its use in individualized management of field cancerization.
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.