The AAD recently added topical tirbanibulin (Klisyri: Almirall) to its list of recommended therapies for treating AK.
The American Academy of Dermatology (AAD) recently added topical tirbanibulin (Klisyri: Almirall) to its list of recommended therapies for treating AK.1
AAD issued a focused update to its Guidelines of Care for the Management of Actinic Keratosis (updated in 2021)2 that included a “strong” recommendation for this first-in-class microtubule inhibitor.
The update, initiated because of the FDA's approval of this treatment for AK on the face and scalp in December 2020,3 is based on a systemic review by an expert work group supported by an AAD corresponding staff author with health research methodology expertise that identified 2 phase 3 trials.4
They used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach “for assessing the certainty of the evidence and formulating and grading clinical recommendations”.
Both trials were randomized, double-blind, parallel-group, and placebo-controlled. Each trial enrolled 351 patients. Using a 1:1 ratio, investigators randomly assigned adult patients with AK on their face or scalp to receive topical tirbanibulin or vehicle (placebo) ointment. The study authors explained that the standard regimen for tirbanibulin in both groups was application to a 25-cm2 contiguous areas containing 4 to 8 lesions once daily for 5 consecutive days.
Results of that study showed:
In its “rationale for recommendation,” the work group “determined that the overall balance of benefits and potential harms as reported at 57 days favors using tirbanibulin for the management of AK on the face and scalp and that the certainty of short-term evidence is high.”
However, the group also noted that the medication may be cost-prohibitive “without adequate insurance” and that other strongly recommended AK treatments may provide lower-cost alternatives.
In its executive summary, the group wrote, “Tirbanibulin is likely acceptable to patients and providers, and feasible to implement especially considering the abbreviated duration of tirbanibulin treatment compares to the duration of other available topical agents for AK.” They added the caution that the current recommendation is based on currently available, short-term evidence specifically for managing AKs on the face and scalp, and that future, longer-term safety data “may impact the direction or strength of the recommendation.”
The American Academy of Dermatology funded the guideline update based on the trial data with internal funds.