A long-term safety study of crisaborole showed few safety concerns, suggesting that the therapy has the potential to treat atopic dermatitis without the side effects of the current topical treatments, said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, San Diego, and his associates.

The multicenter, long-term, open-label safety study of 48 weeks assessed 517 patients with mild to moderate atopic dermatitis after they had finished a 28-day phase 3 study of 2% crisaborole ointment. The patients in the extension study were told to apply crisaborole twice daily for 28 days, with an off-treatment period initiated if their disease severity was clear or almost clear after the 28 days. They were told to stop the treatment if they had no improvement in their Investigator’s Static Global Assessment score after three consecutive treatment periods.

A total of 60% of patients were children, and 29% of patients were black or African American. The patients had an average of six on-treatment periods, with an overall mean amount of drug applied per application of 2.34 g.

Treatment-related adverse events occurred in 10% of patients; 86% of them were mild or moderate. Dermatitis atopic – defined as worsening, exacerbation, flare, or flare-up – occurred in 3% of patients; application-site burning or stinging in 2%; and application-site infection in 1%. The median duration was 18 days for dermatitis atopic, 5 days for application-site burning or stinging, and 12 days for application-site infection. The frequency of these adverse events did not increase over time, the investigators said.

Most patients (78%) did not need rescue therapy, 79% later resumed crisaborole therapy at a later date, and 76% stayed in the study until week 48 or the end of the study.

Anacor Pharmaceuticals sponsored the study. Dr. Eichenfield received advisory board honoraria from Anacor and Pfizer.

Read more in the Journal of the American Academy of Dermatology ( 2017 Oct;77[4]:641-9 ).


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