Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials

Abstract

Abstract Background DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI 40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3). Objectives The aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups. Methods Adults with moderate-to-severe glabellar lines (Investigator Global Assessment–Frown Wrinkle Severity [IGA-FWS] and Patient FWS [PFWS] scales) were evaluated for glabellar line severity for ≤36 weeks after the first DAXI treatment. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black and African American, and White). Results Overall, 2785 patients were included in the efficacy analysis. 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). Glabellar line severity of none or mild by composite IGA-FWS and PFWS rating was maintained for a median of 24.0 weeks in all age subgroups, and for 27.0, 25.3, and 24.0 weeks in the Asian, Black and African American, and White subgroups, respectively. Treatment-emergent adverse events were similar across all subgroups. Conclusions Consistent with the overall study population, DAXI 40 U demonstrated a high response rate and duration of effect of ≥24 weeks across all age and race subgroups.