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Tirbanibulin Shows Efficacy in Treating Actinic Keratosis Over Larger Skin Areas

• Tirbanibulin 1% ointment demonstrates efficacy and tolerability in treating actinic keratosis (AK) across larger skin fields (100 cm²) on the face and scalp. • A phase 3 open-label study showed a significant reduction in the number of AK lesions after treatment with tirbanibulin over a 5-day period. • The treatment was well-tolerated, with most adverse events being mild to moderate and resolving without discontinuation of the treatment. • The FDA approved tirbanibulin for expanded use up to 100 cm², addressing the need for AK treatments covering larger areas.

A recent phase 3 clinical trial has demonstrated the efficacy and safety of tirbanibulin ointment 1% for the treatment of actinic keratosis (AK) in larger areas of skin, specifically up to 100 cm² on the face and scalp. This expands the previously approved treatment area of 25 cm², offering a new option for patients with extensive AK. The study, published in JAAD International, highlights the potential of tirbanibulin to address an unmet need for field-directed therapies targeting larger areas affected by AK.
The multicenter, open-label study (NCT05279131) included 105 patients in the United States, with a median age of 69.1 years. Participants applied tirbanibulin topically to the affected areas once daily for 5 consecutive days. The primary endpoint was the change in the number of AK lesions from baseline to day 57. Secondary endpoints included safety and tolerability assessments.

Efficacy and Tolerability

The results showed a significant reduction in the mean number of AKs, from 7.7 at baseline to 1.8 at day 57. The number of new AKs remained low throughout the study, with at least 75% of patients having no new lesions at each visit. The most common local tolerability signs (LTS) were mild to moderate erythema (96.1% of patients) and flaking/scaling (84.4% of patients). These LTS peaked around days 5 to 8 and resolved by day 29.
Overall, the treatment was well-tolerated. Application site pruritus (10.5%) and pain (8.6%) were the most common treatment-emergent adverse events, consistent with previous trials of tirbanibulin on smaller treatment areas. No participants discontinued treatment due to adverse events.

Clinical Implications

The study's findings support the use of tirbanibulin ointment 1% for patients with AK on the face or scalp in disease fields up to 100 cm². According to the study authors, "The number of AK field-directed therapies targeting areas >25 cm2 currently available is limited, and does not address all the patient needs. Therefore, there is a need for AK treatments to encompass fields >25 cm2, with an optimal efficacy-tolerability profile and patient convenience."

FDA Approval

In June 2024, the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for tirbanibulin, expanding the approved treatment area to 100 cm². This approval underscores the clinical significance of the study's findings and provides healthcare professionals with a new option for managing AK in larger affected areas. The expanded approval is based on the data from this Phase 3 trial, which demonstrated that tirbanibulin can be safely and effectively used over a larger surface area without detrimental cosmetic changes to the treated skin or relevant changes in pigmentation or scarring.

Study Limitations

The researchers acknowledged limitations, including the short follow-up period and the absence of a placebo group. Despite these limitations, the study provides valuable insights into the safety and efficacy of tirbanibulin for treating AK in larger skin areas.
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Reference News

[1]
Tirbanibulin Demonstrates Efficacy for Actinic Keratosis in Larger Field Treatment
dermatologytimes.com · Oct 12, 2024

Tirbanibulin ointment 1% demonstrated efficacy and tolerability in treating actinic keratosis on fields up to 100 cm², f...

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