Findings from a subgroup analysis of the SAKURA clinical trials show that daxibotulinumtoxinA for injection (DAXI) produces rapid, lasting improvement in the appearance of glabellar lines regardless of patient age or race.
The findings were published in Aesthetic Surgery Journal (Sept. 10, 2022; sjac246). A news report exploring these results is published on page 1 of the Feb. 2023 issue of The Chronicle of Skin & Allergy.
Overall, 2,785 adult patients with moderate-to-severe glabellar lines were included in the efficacy analysis. Glabellar line severity was assessed for up to 36 weeks after their first treatment with DAXI 40 U. Severity was measured using Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] and Patient FWS [PFWS] scales.
The authors of this analysis broke down the SAKURA efficacy and safety data by age (18 to 45 years, >45 to 55, and >55 years) and race (Asian, Black/African American, and White).
Some earlier studies suggested as patients get older, it is harder to get as good results when treating glabellar lines with DAXI, said the new study’s lead author Dr. Nowell Solish in an interview with THE CHRONICLE OF SKIN & ALLERGY. “As we age our lines become more etched in and more permanent. So there is a question of how well people will do [with treatment] as they age.”
Toronto-based dermatologist Dr. Solish is an Assistant Professor at The University of Toronto, as well as the co-director of the Non-Melanoma Skin Cancer clinic at Women's College Hospital.
Dr. Solish and his colleagues also chose to examine outcomes by race, because different skin types age differently, he said.
Because differences between skin types might lead to impaired performance of DAXI in some populations, and because some markets might want racial-specific information for approval, there was value in conducting this subgroup analysis as well as the one by age, he said.
The proportion of patients achieving none or mild glabellar line severity at maximum frown (IGA-FWS) after DAXI treatment was high in all age and race subgroups (>96% at Week 4).
All age groups maintained none or mild severity for a median of 24.0 weeks.
Broken down by race, Asian, Black/African American, and White subgroups maintained none or mild severity for a mean of 27.0, 25.3, and 24.0 weeks, respectively.
Treatment-emergent adverse events (TEAE) were similar across all subgroups. Headache was the most commonly seen TEAE in all age and racial subgroups (4% to 5%), except the Black/African-American subgroup. That subgroup reported injection site pain at a higher incidence (8.7%), though 75% of those reports came from just two of 66 study sites.
The incidence of eyelid ptosis was 0.5%, 1.3%, and 1.7% in the 18 to 45, >45 to 55, and > 55-year subgroups, respectively, and 0%, 1.4%, and 1.1% in the Asian, Black or African American, and White subgroups, respectively.