Tirbanibulin Ointment Clears Actinic Keratosis Lesions
Just five treatments with an experimental ointment over five days were able to completely clear actinic keratosis lesions in half of all volunteers within two months, although one year after treatment the lesions had reappeared in many cases, according to a new study.

The lesions cleared in 49% of the 353 volunteers randomly assigned to use an ointment containing the Athenex drug tirbanibulin, versus 9% among the 349 patients given an identical cream without the drug, researchers report.

The benefit of the single treatment course, when it worked, was usually only temporary. At the one-year mark, 71% of the patients had a new or recurrent lesion.

In addition, the therapy produced some local reactions in most recipients and application-site pain in 10%, although researchers said those side effects were significantly less bothersome than conventional treatments.

The results “are right in line with the other field treatments that tend to be more irritating and induce more inflammation. In the case of this treatment, the skin reaction, the side effects are minimal to none, and that’s a big difference compared to the other field therapies for this very common disease,” researchers added.

In the new study, the patients had actinic keratosis on their face or scalp, with 4-8 lesions within 25 cm2.

Among the volunteers who received the drug-laced cream, partial clearance – defined as clearance of at least 75% of lesions – occurred in 72% of patients, versus 18% of volunteers in the placebo group.

Of the 174 people who initially had complete clearance, 124 had lesions reappear or appear anew in the treatment field.

“One of the knocks against this drug had been the recurrence rate,” said researchers. “But if you look at all the studies done on other topical treatments available for this disease, they were done for shorter time periods and didn’t have a one-year follow-up.”

“But it’s not uncommon to retreat the area many times over several years. So, this is typical not only for this drug but any therapy for actinic keratosis,” they mentioned. “What really this drug needs now is additional studies where you are treating longer with repeated courses.”

The rates of any adverse events were 35% with tirbanibulin versus 36% with placebo. Erythema occurred in 91% of the patients getting the cream containing the drug. Scaling was seen in 82% of cases. All of the local reactions were temporary. The pain, seen in 10% of the recipients, tended to consist of a slight tenderness, said researchers. Pruritus appeared in 9% of the volunteers getting the drug.