Tirbanibulin ointment applied daily for 5 days was safe and effective for the treatment of actinic keratosis (AK) lesions according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
Data from 2 phase 3, randomized, double-blind, vehicle-controlled trials were analyzed for this study. Patients with 4 to 8 AK lesions in a 25-cm2 area were randomly assigned to receive 1% tirbanibulin ointment (n=353) or vehicle placebo (n=349) for 5 days. Clearance of AK lesions was evaluated at day 57 and recurrence at 1 year.
Patients in the treatment and placebo groups had a mean age of 69.3 (standard deviation [SD], 8.6) and 70.2 (SD, 9.1) years and 86% and 87% were men, respectively. Median lesion count was 6.0 (range, 4-8) in all participants.
Complete clearance of lesions was achieved by 49% of the tirbanibulin group and 9% of the placebo cohort (P <.0001) and partial clearance by 72% and 18% (P <.0001), respectively. Recipients of tirbanibulin exhibited fewer median lesions at all treatment visits (all, P <.0001).
Local skin reactions (LSRs; erythema, crusting, swelling, flaking, scaling, pustulation, vesiculation, erosion, ulceration) peaked at day 8 among the treatment group (mean LSR score, 4.1±2.32). By day 15, LSR scores were significantly decreased. Severe LSRs were reported by less than 10% of the population and no patient required an intervention. Tirbanibulin and placebo recipients reported application site pain (10% vs 3%) and pruritus (9% vs 6%), respectively.
Among the tirbanibulin cohort (n=124), at 1 year 73% had an AK lesion and 47% had a recurrent lesion in the treatment area. Most participants had 1 (57.3%) or 2 (29.0%) lesions and few had 3 (11.3%), 4 (0.8%) or 6 (1.6%). Among the patients with an AK lesion at 1 year, 51.6% had only recurrent lesions, 41.9% had new lesions, and 6.5% had both new and recurrent lesions.
This study was limited by the sex imbalance and lack of ethnic diversity, in which more than 99% of the participants were White. It remains unclear whether findings would be similar among a more diverse patient population, it was acknowledged.
These data indicated to the investigators that 1% tirbanibulin ointment was safe and effective for the treatment of AK lesions.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
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Blauvelt A, Kempers S, Schleisinger R, et al. Tirbanibulin ointment 1% for actinic keratosis (AK): pooled data from two phase 3 studies. Presented at: American Academy of Dermatology (AAD) VMX 2021; April 23-25, 2021. Abstract/Poster 25933.