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Tirbanibulin for actinic keratosis

Actinic keratosis is a common dermatological disorder which can develop into squamous cell carcinoma. If there are a number of confluent lesions (actinic field change), the current treatment usually consists of fluorouracil cream, the drug of first choice. In July 2021, an ointment containing tirbanibulin (Klisyri®) was authorised for the treatment of actinic keratosis. Tirbanibulin is the first tyrosine kinase inhibitor intended for cutaneous application. An indirect comparison by means of a network meta-analysis found no significant differences in efficacy between tirbanibulin ointment, fluorouracil cream and imiquimod cream. 

  • When patients with an actinic field change are treated with tirbanibulin ointment, the lesions disappear completely in a significantly higher percentage of patients than when they are treated with placebo (49% vs. 9%).
  • In 71% of the treated patients, the lesions return or new lesions arise at the treated site. This is comparable to existing therapies.
  • An indirect comparison by means of a network meta-analysis found no difference in efficacy between tirbanibulin ointment and fluorouracil cream or imiquimod cream.
  • Since there have been no direct comparative studies, no indication of the position of tirbanibulin relative to existing treatments can be given. 
  • Advantages of treatment with tirbanibulin ointment are the short duration (5 days) and the possibly mild adverse effects, while disadvantages include the lack of experience with this drug and its higher price. 
  • Based on the above, the Ge-Bu drug rating for tirbanibulin ointment is +/-

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  • Erik P. Schwarz