HealthDay News — Tirbanibulin is superior to vehicle at 2 months for the treatment of actinic keratosis, but almost half of patients who had a complete response experienced recurrence of lesions at one year, according to a study published in the Feb. 11 issue of the New England Journal of Medicine.
Andrew Blauvelt, MD, from the Oregon Medical Research Center in Portland, and colleagues randomly assigned adults with actinic keratosis on the face or scalp to receive either topical tirbanibulin or vehicle (placebo) ointment in a 1:1 ratio in 2 identically designed double-blind trials (351 patients per trial). Ointment was applied to a 25-cm2 contiguous area once daily for 5 consecutive days.
The researchers found that in trial 1, complete clearance occurred in 44 and 5% of patients in the tirbanibulin and vehicle groups, respectively, at day 57; in trial 2, the corresponding percentages were 54 and 13%. Compared with the vehicle groups, the tirbanibulin groups had significantly higher percentages of patients with partial clearance. Among patients who had had a complete response to tirbanibulin, the estimated percentage with recurrent lesions was 47% at one year. The most common local reactions to tirbanibulin were erythema and flaking or scaling (91 and 82%, respectively).
“Larger and longer trials are necessary to determine the effects and risks of tirbanibulin therapy among patients with actinic keratosis,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Athenex, which developed tirbanibulin and funded the study.