A 2-point composite response at maximum frown at week four was achieved by 73% of patients after the first treatment cycle, which was nearly identical to the results in SAKURA 1 and 2. In SAKURA 3, the response rates were 78% after cycle two and 80% after cycle three.
“The majority of patients in SAKURA 3 were rated prior to treatment as having either moderate or severe glabellar lines. That means they would have to improve to “none” to achieve a 2-point composite response, and that is a very high bar to cross,” Dr. Fabi says.
At week 24 after DAXI injection, approximately one-third of patients had a wrinkle severity score of none to mild. Using a Kaplan-Meier time to event analysis, the median time to loss of none or mild rating was 24 weeks. Median time to return to baseline severity was approximately 28 weeks. Patient satisfaction was high, she says.
Adverse events were mild, transient and mostly limited to local reactions that would be expected with any needle injection, (eg, injection site pain and erythema), as well as headache that is widely reported with neuromodulator injections for treatment of glabellar lines. The rates of injection site pain, erythema and headache in SAKURA 3 were all <6%.
Overall, 1.3% of patients experienced eyelid ptosis, and the rate of eyelid ptosis per treatment was 0.9% per treatment. Results from SAKURA 1 and SAKURA 2 were reported in articles published online in Plastic and Reconstructive Surgery and the Journal of the American Academy of Dermatology. The two identically designed studies included a total of 405 patients who received a single treatment with DAXI 40 U.
Revance Therapeutics submitted a Biologics License Applications to the FDA for DAXI in the treatment of moderate-to-severe glabellar lines in November 2019.
Dr. Fabi is an investigator for Allergan, Croma, Galderma, Merz, and Revance and has stock in Allergan and Revance.