Mild to moderate local tolerability signs on patients who achieved complete clearance after treatment with tirbanibulin 1% ointment in actinic keratosis (TIRBASKIN study)

Background: Tirbanibulin 1% ointment has recently been approved for the treatment of the cancerization field in Olsen grade I actinic keratosis (AK).It exerts its effects by inhibiting tubulin polymerization and Src kinase signaling, leading to antiproliferative and pro-apoptotic activities.Unlike other topical therapies, tirbanibulin appears to cause a lower release of cytokines, which results in less tissue necrosis and inflammation.Clinically, this translates into good tolerability and a favorable safety profile.Furthermore, given its mechanism of action, which does not engage the patient's immune system, it is hypothesized that the safety and efficacy profiles of tirbanibulin are similar in both immunosuppressed and immunocompetent patients.The aim of this study was to assess the tolerability and adverse skin effects of tirbanibulin in solid organ transplant recipients who are immunosuppressed due to their condition.Methods: A single-center, prospective study was conducted to evaluate local skin responses and pain levels in 39 immunosuppressed patients undergoing treatment with tirbanibulin.Pain level was evaluated using a numeric pain scale from 0 (no pain) to 10 (highest pain) Patients were assessed on day 8 (+/-2 days) following the initiation of tirbanibulin, which is the day when the most significant local adverse effects are typically observed.Results: A total of 39 patients were included in the study (37 men and 2 women), all of whom had been under immunosuppressive therapy for at least one year and had between 4 and 8 AK lesions in the treatment area.All patients completed the 5-day treatment regimen.Pain was reported in only 9 patients, with the highest pain score being 4/10 in one individual.Erythema and scaling were the most common local adverse effects, occurring in 100% and 87.2% of patients, respectively.Crusting was observed in 17 patients (43.6%), swelling in 16 patients (41%), vesicles or pustules in 3 patients (7.7%), and erosion in 13 patients (33.3%).No severe adverse events (grade 4) were reported.Conclusions: The treatment with tirbanibulin ointment demonstrates a favorable safety profile in solid organ transplant recipients.While all patients experienced local adverse effects, they were generally mild in severity, as reflected in the low pain reports, with only 9 patients experiencing pain at all.This suggests that tirbanibulin can be safely used in this immunosuppressed patient population.