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Italian journal of dermatology and venereology · 2026

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

СтатьяНазвание и аннотация: Перевод в очереди
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Carugno Andrea, Nazzaro Gianluca, Argnani Lisa, Bellinato Francesco, Zappia Elena, Masala Maria V, Dal Bello Giacomo, Valenti Mario, Addari Giampaolo, Ciccarese Giulia, Bruni Manfredo, Trovato Emanuele, Paolino Giovanni, Balestri Riccardo, D'Arino Andrea, Magnoni Cristina, Zavattaro Elisa, Toni Giulia, Giuffrida Roberta, Verdelli Alice, Caccavale Stefano, Villani Alessia, Giacalone Serena, Recalcati Sebastiano, Barruscotti Stefania, Bighetti Stefano, Bettolini Luca, Fiorillo Giovanni, Germi Lerica, Fazio Stefano, Cantisani Carmen, Maione Vincenzo, Infusino Salvatore D, Eibenschutz Laura, Cesari Alice, Dragotto Martina, Zolo Grazia B, Verzì Anna E, Savoia Paola, Zalaudek Iris, Sala Elia, Errichetti Enzo, Mercuri Santo R, Esposito Maria, Foti Caterina, Atzori Laura, Ardigò Marco, Lacarrubba Francesco, Fargnoli Maria Concetta, Danese Pietro, Ribero Simone, Gisondi Paolo, Marzano Angelo V, Zerbinati Nicola

Аннотация

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.