Real-world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non-interventional KLIR study
Heppt M, Hadshiew I, Kempf A, Melzer A, Berking C (2025)
Publication Type: Journal article
Publication year: 2025
Journal
DOI: 10.1111/ddg.15876
Abstract
Background: Tirbanibulin is an approved topical treatment for actinic keratosis (AK). This non-interventional study investigated effectiveness and safety of tirbanibulin for AK. Patients and Methods: The prospective KLIR-study was conducted at 58 German dermatology centers (02/2022–09/2023). Patients received tirbanibulin once daily for 5 consecutive days. Lesion count reduction, clearance rates, safety, and treatment satisfaction were assessed at day 57 (visit 3) after treatment. Visits on days 0, 8–29, and 240 allowed for the evaluation of baseline data, local skin reaction (LSR) peaks, and lesion recurrence, respectively. Results: In total, 545 AK patients were included in the study. The mean number of AK lesions decreased from 5.9 (baseline) to 1.9 at visit 3, representing a 70% lesion count reduction (p < 0.0001). Clearance rates at visit 3 were 37.4% (complete clearance) and 55.0% (partial clearance ≥ 75% reduction). Among patients with complete clearance at visit 3, 21.9% experienced recurrent AK lesions at visit 4. The majority of LSRs were mild or moderate. Erythema (97.6%) was the most common LSR. Overall, 91.5% of patients rated their AK lesions as improved and 99% would consider future tirbanibulin treatment (“definitely”, “certainly”, “probably”, “maybe”). Conclusions: Tirbanibulin showed high lesion clearance and a high level of acceptance in real-life conditions.
Authors with CRIS profile
Markus Heppt
Department of Dermatology
Carola Berking
Lehrstuhl für Haut- und Geschlechtskrankheiten
Involved external institutions
Germany (DE)How to cite
APA:
Heppt, M., Hadshiew, I., Kempf, A., Melzer, A., & Berking, C. (2025). Real-world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non-interventional KLIR study. Journal der Deutschen Dermatologischen Gesellschaft. https://doi.org/10.1111/ddg.15876
MLA:
Heppt, Markus, et al. "Real-world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non-interventional KLIR study." Journal der Deutschen Dermatologischen Gesellschaft (2025).
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