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Phase 3 Trial Finds Tirbanibulin Effective for AKs, More Long-term Data Needed

A study published in New England Journal of Medicine found tirbanibulin was superior to vehicle as a topical treatment for actinic keratoses (AKs) but was associated with transient localized reactions and recurrence at 1 year.

Adults with AKs on the face or scalp were randomly assigned to receive either topical tirbanibulin 1% or vehicle (placebo) ointment in two identically designed double-blind trials at a 1:1 ratio. Once a day, patients applied the ointment to a 25-cm2 contiguous area containing four to eight lesions for 5 consecutive days. After 57 days of treatment, the primary outcome evaluated was the percentage of patients with complete reduction in the number of AKs and the secondary outcome was percentage of patients with a partial (≥75%) reduction. Local reactions were scored with the use of 4-point scale (ranging from 0 [absent] to 3 [severe]), and after 1 year, incidence of recurrence was evaluated.

There were 702 patients enrolled in the trials, with each trial consisting of 351 patients. In trial 1, 44% (77/175) of the patients in the tirbanibulin group had complete clearance vs only 5% (8/176) in the vehicle group (95% CI, 32-47; P<.001). For trial 2, these percentages increased to 54% (97/178) and 13% (22/173) patients (95% CI, 33-51; P<.001). These percentages revealed that patients with partial clearance were significantly higher in the tirbanibulin groups than in the vehicle groups.

At 1 year, it was estimated that 47% of patients with recurrent lesions previously achieved a complete response to tirbanibulin. Common local reactions to tirbanibulin were erythema (91%) and flaking or scaling (82%); adverse events experienced were application-site pain (10%) and pruritus (9%), all of which resolved.

Based on the results of these two trials, tirbanibulin applied once daily for 5 days was superior to vehicle for the treatment of AKs after 2 months, but the treatment was associated with transient local reactions and recurrence of lesions at 1 year. Further trials to compare tirbanibulin with conventional treatments and with longer follow-up are needed. —Jessica Garlewicz



Blauvelt A, Kempers S, Lain E, et al. Phase 3 trials of tirbanibulin ointment for actinic keratosis. N Engl J Med. Published online February 11, 2021. doi:10.1056/NEJMoa2024040

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