Drug updated on 9/4/2024
Dosage Form | Ointment (topical; 1%) |
Drug Class | Microtubule inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the topical treatment of actinic keratosis of the face or scalp.
Latest News
Summary
- Klisyri (tirbanibulin) is indicated for the topical treatment of actinic keratosis of the face or scalp.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Tirbanibulin 1% ointment demonstrated an odds ratio (OR) of 11.1 (95% credible interval: 6.2-20.9) for achieving complete clearance of actinic keratosis (AK) on the face and scalp when compared to a topical placebo or vehicle.
- When compared to other treatments, Tirbanibulin showed varying odds ratios: 13.4 (6.2-30.3) against cryosurgery, 2.9 (1.9-4.3) against Diclofenac 3%, 7.6 (4.6-13.5) against Fluorouracil 0.5% + salicylic acid, and 12.5 (8.1-19.9) against Ingenol mebutate 0.015%. Higher ORs were noted against Fluorouracil 4% (30.3, 9.1-144.7), Fluorouracil 5% (35.0, 10.2-164.4), and certain photodynamic therapies.
- Tirbanibulin was noted to have a favorable safety profile, with no serious or systemic adverse events reported, and a more favorable tolerability profile compared to topical 5-FU and imiquimod.
- Application-site adverse events and local skin reactions were less frequent with newer agents like tirbanibulin and ingenol mebutate, indicating minimal safety concerns.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Klisyri (tirbanibulin) Prescribing Information. | 2020 | Almirall, LLC, Exton, PA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Systematic review of randomized controlled trials of topicals for actinic keratosis field therapy. | 2024 | Archives of Dermatological Research |
Comparative efficacy and safety of tirbanibulin for actinic keratosis of the face and scalp in Europe: a systematic review and network meta-analysis of randomized controlled trials. | 2022 | Journal of Clinical Medicine |
Individual article: safety and tolerability of topical agents for actinic keratosis: a systematic review of phase 3 clinical trials. | 2021 | Journal of Drugs in Dermatology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Focused update: Guidelines of care for the management of actinic keratosis. | 2022 | Journal of the American Academy of Dermatology |
Guidelines of care for the management of actinic keratosis. | 2021 | Journal of the American Academy of Dermatology |