1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses

Abstract

Objective Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new topical treatment for AKs, recently approved by the Food and Drug Administration. Data Sources The PubMed database was searched for articles published from 1960 to March 31, 2021, using the keywords tirbanibulin and Klisyri. Data Extraction Phase 2 and phase 3 clinical trials were reviewed. Data Synthesis In phase 2 clinical trials, 43% of patients treated with tirbanibulin experienced complete clearance by day 57 (43% [95% CI = 32, 54]). Across two phase 3 clinical trials (pooled data), complete (100%) clearance occurred in 49% of patients in tirbanibulin groups and in only 9% of the vehicle groups (difference, 41% points; 95% CI = 35 to 47; P < 0.001). Although no comparative studies are available, tirbanibulin is applied for a shorter duration (5 days) compared with diclofenac 3% gel, fluorouracil 5% cream, and imiquimod 3.75% cream. Adverse events were mild and included pruritus, application site pain, and local skin reactions. Systemic adverse events such as necrosis and angioedema, observed with other AK treatments such as fluorouracil and imiquimod, were not observed with tirbanibulin, thus giving tirbanibulin a favorable safety profile. Relevance to Patient Care and Clinical Practice Tirbanibulin effectively reduces AK burden and recurrence and has a favorable safety profile with mild adverse events. In comparison, imiquimod, 5-flourouracil, and diclofenac can result in necrosis, angioedema, and arthralgias. Conclusion With a favorable safety profile and short regimen, tirbanibulin is an efficacious treatment for clinicians to utilize in their treatment toolbox when treating AKs on the face and scalp.

Prevention, diagnosis and treatment of actinic keratosis

“…It is applied for a shorter duration than other topical agents (once daily for five days) and has relatively mild local adverse effects. 33…”

“…In two phase 3 clinical trials, tirbanibulin achieved complete clearance in 49% of patients. It is applied for a shorter duration than other topical agents (once daily for five days) and has relatively mild local adverse effects 33 …”

Update on diagnosis and treatment of actinic keratosis

“…All patients had previously shown complete clearance of AK lesions after 57 days of treatment with Tribanibulin 26 . A recent review has also advocated tribanibulin as a safe and effective therapeutic option for AKs on the scalp and face with improved patient compliance due to its shorter treatment regimen 27 …”

“…26 A recent review has also advocated tribanibulin as a safe and effective therapeutic option for AKs on the scalp and face with improved patient compliance due to its shorter treatment regimen. 27 The effectiveness of chemical peels in AK is 75%, with 25%-35% relapse rate within 1 year. 19,21 Combination treatment like 5FU with 70% glycolic acid or Jessner's peel has better efficacy than chemical peels alone.…”

Tirbanibulin 1% ointment eradicates HPV‐16 (+) vulvar high‐grade squamous intraepithelial lesion

“…8 Inhibition of tubulin polymerization for indirect disruption of Src activity by tirbanibulin is hypothesized to prevent HPV16 progression to HSIL. 9 In mechanistic studies, the dual approach provided much broader efficacy when compared to tubulin polymerization inhibitors or Src inhibitors individually. 3 Tirbanibulin ointment may inhibit SCC or directly on HPV-driven carcinogenesis.…”