Tirbanibulin Proven Safe and Tolerable for Larger Actinic Keratosis Fields, Expanding Treatment Options: Study

USA: Tirbanibulin ointment, at a 1% concentration, demonstrates good safety and effectiveness for treating actinic keratosis (AK) on areas up to 100 cm² on the face and scalp, a recent study published in the Journal of American Academy of Dermatology has concluded.

The study highlights that Tirbanibulin 1% ointment has the potential to be used in larger fields, which leads to expanding its applicability for patients with extensive lesions.

Tirbanibulin is approved for treating actinic keratosis in areas up to 25 cm². However, because actinic keratosis frequently impacts larger regions, there is a need for treatments that can address larger affected areas. Considering this, Neal Bhatia, Therapeutics Clinical Research, San Diego, CA, USA, and colleagues aimed to evaluate the tolerability and safety of tirbanibulin when applied to a field of approximately 100 cm2.

For this purpose, the research team conducted a single–arm study with adult patients having a treatment field on the face or balding scalp of 100 cm² with 4-12 AKs. Patients received tirbanibulin 1% ointment to cover the treatment field once daily for five consecutive days. Safety was assessed by evaluating treatment-emergent adverse events (TEAEs) and tolerability was measured using a composite score of six local tolerability signs (LTS).

The study was performed with the participation of 102 patients. The trial was conducted from June 2022 to December 2022 in the United States by the Declaration of Helsinki and The International Council for Harmonization Good Clinical Practice guidelines, a 4-week screening, a 5-day treatment, and a 7-week response evaluation period were conducted. Till the completion of the assessment period on Day 57 safety, tolerability, and presence of Aks were evaluated.

They found the following results

· Around 96.1% of LTS were erythema and 84.4% were scaling, they are mostly from mild to moderate severity, and they return to baseline by Day 29.

· 5.8% of severe LTS were erythema and 8.7% were flaking/ scaling.

· At day 57 the mean total number of Aks decreased from 7.7 Aks at baseline to 1.8 Aks. 77.8% was a reduction in the baseline lesion.

"Local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm². These results support the safety of tirbanibulin 1% ointment for use in patients with actinic keratosis (AK) on the face or scalp in treatment areas up to 100 cm²”, the researchers concluded.

Reference:

https://doi.org/10.1016/j.jdin.2024.07.001