Drug updated on 5/17/2024
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
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Summary
- Tirbanibulin (Klisyri) is indicated for the topical treatment of actinic keratosis of the face or scalp. It has been assessed across multiple documents for its role in treating this condition, focusing on its effectiveness and safety profile.
- Three systematic reviews/meta-analyses were reviewed to gather information about Klisyri's comparative effectiveness and safety profiles against various treatments for actinic keratosis.
- In terms of comparison to other treatments, tirbanibulin received a clinical recommendation grade C, placing it alongside calcipotriol/5-fluorouracil, imiquimod, and combination therapies involving sunscreen but behind 5-Fluorouracil/salicylic acid (grade A) and diclofenac sodium (grade B).
- The Bayesian network meta-analysis suggests that while fluorouracil 5% and photodynamic therapy with aminolevulinic acid have higher odds ratios indicating greater efficacy, tirbanibulin also shows promising results with an odds ratio of 11.1, suggesting competitive effectiveness.
- Regarding safety and tolerability, newer agents like tirbanibulin are reported to have more favorable safety profiles compared to older treatments such as 5-FU and imiquimod, according to one study specifically addressing these aspects among FDA-approved topical agents for AK.
- While detailed subgroup analyses based on age, gender, or severity are not explicitly discussed; overall evaluations suggest that the therapeutic landscape involves selecting treatment options that balance efficacy with safety and tolerability, implying considerations for use in populations prioritizing minimal side effects or having concerns regarding tolerability.
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 |