Tirbanibulin Reduces Actinic Keratosis Lesions, Achieves High Patient Satisfaction

Data from the 2025 American Academy of Dermatology (AAD) Annual Meeting offer new insight into both the clinical efficacy of tirbanibulin (Klisyri) as well as patient perspectives on treatment satisfaction with the topical agent when treating actinic keratosis.

The data, which was a pooled analysis of data from a pair of post-registration studies, demonstrate more than 70% of patients achieved complete or partial clearance of lesions, with treatment satisfaction data also purporting high scores for the effectiveness, convenience, and global satisfaction domains.1,2

"Patient satisfaction is a significant aspect of treatment outcomes,” said Darrell Rigel, MD, MS, clinical professor at Mount Sinai Icahn School of Medicine.2 “The results of these studies with tirbanibulin indicate notable improvements in patient satisfaction in real-world scenarios, which supports adherence to [actinic keratosis] treatment protocols thus paving the way for more sustainable outcomes. By prioritizing patient experience and addressing their needs, the effectiveness of therapies can be enhanced, which can lead to an overall improvement in the quality of care.”

Although it may not consistently garner the same level of media attention as other dermatologic conditions, actinic keratosis represents an area of significant unmet need within the dermatology community. According to a 2024 study assessing global prevalence from major databases suggested an overall prevalence of approximately 14%. With untreated actinic keratosis sometimes progressing to cancer, improving management stands to have a considerable impact of long-term prognosis for patients.3

Initially approved in December 2020 for treatment of actinic keratosis on the face or scalp for areas up to 25 cm2, the US Food and Drug Administration approved an additional indication for the agent for 100 cm2 in June 2024 based on data from a phase 3, multicenter, open-label, clinical safety study with more than 100 participants in the US.4

At AAD 2025, investigators presented data derived from a pair of post-registration studies, PROAK and TirbaSkin. PROAK was a single-arm, prospective cohort study conducted in 278 US adults with actinic keratosis on face or scalp as part of usual care. TirbaSkin was an open phase IV multicenter, single-cohort trial conductedin adult patients (N=328 evaluable) with AK on the face or scalp from Spain or Italy.1,2

In both studies, patients applied tirbanibulin once daily for 5 days to an area of approximately 25 cm2. As part of both studies, patients completed the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) at 8 weeks.

At AAD 2025, a combined analysis of 606 evaluable patients from PROAK and TibraSkin indicated 74.3% of patients using tirbanibulin achieved complete or partial (≥75%) clearance of actinic keratosis lesions. Analysis of treatment satisfaction indicated pooled TSQM-9 scores were 73.5 for Effectiveness, 83.8 for Convenience, and 74.7 for Global Satisfaction. Investigators pointed out observed adverse events and local skin tolerability were consistent with data from phase 3 trials.1,2

"Our close collaboration with the dermatology community and patients allows us to better understand their needs and develop effective solutions. The findings presented at AAD 2025 show our focus on delivering impactful data on our established products as well as progressing our early-stage pipeline. The data on tirbanibulin for the treatment of actinic keratosis highlight the importance of a patient-centered approach to achieve treatment success,” said Volker Koscielny, MD, MBA, chief medical officer of Almirall.2

Reference:

1. Kircik L, Schlesinger T, BermanB et al. Relating patient-reported treatment satisfaction and clinical outcomes in post-registration studies of tirbanibulin for actinic keratosis (AK). Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Almirall. AAD 2025: Almirall presents early-stage pipeline progress and real-world evidence on demonstrating AK treatment success and patient satisfaction with Tirbanibulin. Business Wire. March 7, 2025. Accessed March 7, 2025. http://www.businesswire.com/news/home/20250307364570/en/AAD-2025-Almirall-presents-early-stage-pipeline-progress-and-real-world-evidence-on-demonstrating-AK-treatment-success-and-patient-satisfaction-with-Tirbanibulin.

3. George CD, Lee T, Hollestein LM, Asgari MM, Nijsten T. Global epidemiology of actinic keratosis in the general population: a systematic review and meta-analysis. Br J Dermatol. 2024;190(4):465-476. doi:10.1093/bjd/ljad371

4. Almirall. FDA approves Almirall’s Klisyri® (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. Almirall.com. June 10, 2024. Accessed March 7, 2025. https://www.almirall.com/newsroom/news/fda-approves-almirall-s-klisyri-tirbanibulin-for-the-treatment-of-actinic-keratosis-on-expanded-area-of-face-or-scalp-up-to-100-cm2.