Drug updated on 3/28/2024
| Dosage Form | Ointment (topical: 1%) |
| Drug Class | Microtubule inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the topical treatment of actinic keratosis of the face or scalp.
Summary
- Tirbanibulin (Klisyri) is indicated for the topical treatment of actinic keratosis of the face or scalp.
- A total of 46 studies were reviewed in a systematic review/meta-analysis, which included an examination of tirbanibulin's efficacy and safety for treating actinic keratosis on the face and scalp.
- The analysis revealed that tirbanibulin 1% has an odds ratio and 95% credible intervals at 11.1 (6.2-20.9), suggesting its effectiveness in clearing up actinic keratosis when compared to other treatments such as cryosurgery, diclofenac, fluorouracil with salicylic acid among others.
- Four sensitivity analyses confirmed these findings: assessing efficacy after one treatment cycle only; considering a ≥25 cm² treatment area; evaluating results after eight weeks post-treatment; and using single placebo/vehicle node.
- In terms of safety outcomes, they were assessed qualitatively but no specific details are provided within this study about any potential side effects or adverse reactions associated with Klisyri use.
- Tirbanibulin offers a novel approach to treating AK due to its short single treatment period along with favorable safety profile making it comparable to existing topical treatments available in Europe according to a study conducted across multiple clinical trial registries and regulatory body websites.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Klisyri (tirbanibulin) Prescribing Information. | 2021 | Almirall, LLC, Exton, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| 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 |
| Assessment report: Klisyri. | 2021 | EMA |
| 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 |
|---|---|---|
| Guidelines of care for the management of actinic keratosis. | 2021 | Journal of the American Academy of Dermatology |