34967 DaxibotulinumtoxinA for injection demonstrates consistent safety and efficacy in African American subjects: Subgroup analysis from a large, open-label, repeat-dose study

Abstract

African American (AA) individuals account for 9% of cosmetic procedures in the USA. DaxibotulinumtoxinA for injection (DAXI) is a novel botulinum toxin type A in clinical development for moderate-to-severe glabellar lines (GL). We compare the safety and efficacy of DAXI in AA vs. Caucasian subjects. SAKURA 3 was a multicenter, 84-week, prospective, open-label, repeat-dose study in subjects with moderate-to-severe GL. The study included rollover subjects (both active and placebo) from the preceding double-blind studies (SAKURA 1 and 2) as well as de novo subjects. Subjects received ≤3 treatments with DAXI 40U. The study enrolled 2691 subjects (477 from SAKURA 1/2; 2214 de-novo). In treatment cycle 1 (n = 2380), 119 (5%) AA subjects and 2130 (89.5%) Caucasian subjects received DAXI, and 98.3% of AA vs. 95.7% of Caucasian subjects achieved none/mild GL (investigator assessment) at Week 4. Median time to loss of none/mild GL (investigator and subject assessment) for AA and Caucasian subjects was 25.7 and 24.0 weeks, respectively, and median time to return to baseline GL status (investigator and subject assessment) was 28.3 and 28.0 weeks, respectively. Common treatment-related adverse events in AA subjects were injection site pain, headache, facial paresis (reported as “forehead muscle weakness”), erythema, and edema. There were no treatment-related cases of brow ptosis or dyschromia. DAXI demonstrated a high degree of efficacy and a duration of effect in AA subjects similar to that observed in Caucasian subjects. No new safety signals were identified. These data demonstrate consistent safety and efficacy of DAXI in AA subjects.