Tirbanibulin Maintains Durable 1-Year Efficacy With Favorable Safety in Actinic Keratosis Real-World Study
A real-world extension study suggests that tirbanibulin 1% ointment maintains durable efficacy at 1 year in patients with actinic keratosis (AK), with a favorable safety profile and potential for repeat treatment in long-term disease management.
“Tirbanibulin 1% ointment has demonstrated short-term efficacy and excellent tolerability in the treatment of AK on the face and scalp,” the investigators noted, highlighting the need for long-term outcome data.
In this open-label extension study, 38 patients with a total of 228 AK lesions previously treated with tirbanibulin were re-evaluated at 12 months. Primary endpoints included sustained clearance of previously treated lesions, recurrence rates, and development of new lesions within the treated field.
At 1-year follow up, 116 previously cleared lesions were assessed. Overall, 60.3% (70/116) maintained complete clearance, while 39.7% (46/116) recurred. Clearance rates varied by lesion severity: 68.6% for Olsen grade 1, 56.1% for grade 2, and 37.5% for grade 3 lesions. Additionally, 35 new AK lesions developed within the treated field, consistent with the concept of field cancerization.
Importantly, no late-onset local or systemic adverse events were reported during follow up, supporting a favorable long-term safety profile.
These findings suggest that while recurrence remains common, particularly in higher-grade lesions, tirbanibulin continues to provide meaningful long-term benefit.
“Tirbanibulin demonstrated durable 1-year efficacy. Although recurrences were relatively common, the treatment was well tolerated, with no delayed adverse effects,” the authors concluded. “Its short regimen and favorable safety profile support its role in the long-term management of field cancerization.”
These results reinforce tirbanibulin as a practical field therapy in AK, particularly given its tolerability and suitability for repeated treatment cycles in chronic disease.
Reference
Li Pomi F, Vaccaro M, Borgia F. Efficacy and safety of tirbanibulin 1% ointment for actinic keratosis at 1-year follow-up: a real-life extension study. Presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, Colorado.
