Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment

Abstract

Background: AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections.

Objective: To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies.

Methods: Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events.

Results: One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate.

Conclusion: Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated.

Trial registration: ClinicalTrials.gov NCT02353871 NCT02493946.

Figure 1.

None-or-mild glabellar line severity responders at maximum frown (mITT population); a responder had improved from moderate (Grade 2) or severe (Grade 3) at baseline to none (Grade 0) or mild (Grade 1) post-treatment. Error bars show 95% confidence intervals. For ILA and SSA, the difference between aboBoNT-A solution and placebo was statistically significant at all time points, p < .0001 up to Month 5 and p < .001 at Month 6.

Figure 2.

≥1-grade improvement from baseline in glabellar line severity at maximum frown (mITT population). Error bars show 95% confidence intervals. For ILA and SSA, the difference between aboBoNT-A solution and placebo was statistically significant at all time points, p < .0001.

Figure 3.

Subject satisfaction responder rates over time (mITT population). Responders were “satisfied” or “very satisfied” with the appearance of their glabellar lines post-baseline and “dissatisfied” or “very dissatisfied” at baseline. Error bars show 95% confidence intervals. The difference between aboBoNT-A solution and placebo was statistically significant at all time points, p < .0001.