Efficacy and tolerability of tirbanibulin 1% ointment in the treatment of cancerization field: a real-life Italian multicenter observational study of 250 patients

Gianluca Nazzaro; Andrea Carugno; Paolo Bortoluzzi; Stefano Buffon; Chiara Astrua; Elena Zappia; Emanuele Trovato; Stefano Caccavale; Vincenzo Pellegrino; Giovanni Paolino; Riccardo Balestri; Rossella Lacava; Giulia Ciccarese; Alice Verdelli; Stefania Barruscotti; Mario Valenti; Giulia Toni; Serena Giacalone; Elisa Zavattaro; Laura C Gironi; Santo R Mercuri; Simone Ribero; Paolo Gisondi; Paolo Sena; Angelo V Marzano

doi:10.1111/ijd.17168

Efficacy and tolerability of tirbanibulin 1% ointment in the treatment of cancerization field: a real-life Italian multicenter observational study of 250 patients

Int J Dermatol. 2024 Apr 11. doi: 10.1111/ijd.17168. Online ahead of print.

Authors

Gianluca Nazzaro¹, Andrea Carugno^{2

3}, Paolo Bortoluzzi¹, Stefano Buffon^{1

4}, Chiara Astrua⁵, Elena Zappia^{5

6}, Emanuele Trovato⁷, Stefano Caccavale⁸, Vincenzo Pellegrino⁸, Giovanni Paolino^{9

10}, Riccardo Balestri¹¹, Rossella Lacava¹¹, Giulia Ciccarese¹², Alice Verdelli¹³, Stefania Barruscotti^{14

15}, Mario Valenti^{16

17}, Giulia Toni¹⁸, Serena Giacalone¹⁹, Elisa Zavattaro²⁰, Laura C Gironi²⁰, Santo R Mercuri^{9

10}, Simone Ribero⁵, Paolo Gisondi²¹, Paolo Sena², Angelo V Marzano^{1

4}

Affiliations

¹ Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
² Dermatology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
³ University of Milan-Bicocca, Milan, Italy.
⁴ Department of Physiopathology and Transplantation, University of Milan, Milan, Italy.
⁵ Department of Medical Sciences, University of Turin, Dermatology Clinic, Turin, Italy.
⁶ Magna Graecia University, Catanzaro, Italy.
⁷ Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.
⁸ Dermatology Unit, Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
⁹ Unit of Dermatology, IRCCS Ospedale San Raffaele, Milan, Italy.
¹⁰ Unit of Dermatologic Clinic, Università Vita-Salute, San Raffaele, Milan, Italy.
¹¹ Division of Dermatology, Azienda Provinciale per i Servizi Sanitari (APSS), Trento and Rovereto, Italy.
¹² Unit of Dermatology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
¹³ Section of Dermatology, Department of Health Sciences, USL Toscana Centre, European Reference Network-Skin Member, University of Florence, Florence, Italy.
¹⁴ Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
¹⁵ Dermatology Clinic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁶ Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.
¹⁷ Department of Biomedical Sciences, Humanitas University, Milan, Italy.
¹⁸ Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
¹⁹ Institute of Dermatology, ASST Valle Olona, Ospedale Sant'Antonio Abate, Gallarate, Italy.
²⁰ Department of Health Science, University of Eastern Piedmont, Novara, Italy.
²¹ Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.

PMID: 38605473
DOI: 10.1111/ijd.17168

Abstract

Background: Tirbanibulin 1% ointment is approved for the field treatment of Olsen grade I actinic keratoses (AKs) of the face and scalp.

Methods: We performed a multicenter retrospective study involving 15 dermatologic units in Italy to investigate the efficacy and tolerability of tirbanibulin in a real-life setting. 250 patients were enrolled. Tirbanibulin, 1% ointment, was applied daily for five consecutive days. The efficacy of treatment was measured with modifications of the Actinic Keratosis Area and Severity Index (AKASI). A satisfactory response was defined by complete (100% reduction in the number of lesions) or partial clearance (75-99%) of treated AKs.

Results: Overall, the AKASI score was significantly reduced in the studied population (mean, from 4.1 ± 2.7 to 1.4 ± 1.5; P < 0.001). A satisfactory response was observed in 222 (88.8%) cases. The proportion of satisfactory responses was higher when follow-up was performed after 8 weeks (34/35, 97.1%). The reduction in AKASI was significant in patients with Olsen grade II or III lesions (from 5.3 ± 2.8 to 1.6 ± 1.6; P < 0.001). A satisfactory response was observed in 91/104 (87.5%) cases. AKASI reduction was also significant in patients with trunk or limb AKs (from 7.0 ± 1.3 to 2.0 ± 1.6; P = 0.018) since a satisfactory response was observed in 7/8 (87.5%) cases. Tirbanibulin was well tolerated; all adverse events (AEs) included transient local reactions at the site of treatment. Overall, 231 patients had at least one AE. Only 7 (2.8%) grade 4 AEs were recorded.

Conclusion: Our retrospective study confirmed that tirbanibulin 1% ointment is effective and well tolerated in a real-life setting and is also promising for Olsen grade II and grade III AKs and AKs localized on difficult-to-treat areas.

Keywords: actinic keratosis; cancerization field; efficacy; real‐life; tirbanibulin; tolerability.