Tirbanibulin 1% ointment for actinic keratoses passes muster in real world

Tirbanibulin 1% ointment proves safe and effective in patients with multiple actinic keratoses (AKs) treated in real-world settings, as shown in a study.

Researchers reviewed the medical records of 250 patients (mean age 74.7 years, 71.2 percent male) who received treatment with tirbanibulin 1% ointment, applied daily for 5 consecutive days. Treatment efficacy was measured using modifications of the Actinic Keratosis Area and Severity Index (AKASI). Complete (100-percent reduction in the number of lesions) or partial clearance (75–99 percent) of treated AKs was considered a satisfactory response.

Of the patients, 21 (8.4 percent) presented with Fitzpatrick phototype I, 159 (63.9 percent) phototype II, and 70 (28.0 percent) phototype III. Most patients (68.4 percent) had comorbidities, the most common of which were hypertension and chronic ischaemic heart disease and diabetes mellitus.

Overall, the mean AKASI score dropped significantly following treatment, from 4.1 to 1.4 (p<0.001). Moreover, the majority of patients (88.8 percent) achieved a satisfactory response. The proportion of patients with satisfactory responses increased to 97.1 percent after 8 weeks.

In the subgroup of patients with Olsen grade II or III lesions, the mean AKASI score decreased from 5.3 to 1.6 with treatment (p<0.001), with 87.5 percent of patients achieving a satisfactory response. The effect of treatment was also significant in patients with trunk or limb AKs (mean AKASI decreasing from 7.0 to 2.0; p=0.018), with a satisfactory response observed in 87.5 percent.

In terms of safety, tirbanibulin was well tolerated. The reported adverse events (AEs) included transient local reactions at the site of treatment. A total of 231 patients had at least one AE, among whom only seven (2.8 percent) had grade 4 AEs.

The findings show the potential of tirbanibulin for treating Olsen grade II and grade III AKs, as well as AKs localized on difficult-to-treat areas.