AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study

Abstract

Objective: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines. Design: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. Methods: Primary endpoint Adults with was moderate-to-severe week 4 composite ≥2-grade glabellar lines responder Do received Not rate a among single Copy ABO those treatment, achieving dosed a severity at 50, score 75, 100, of 0 or (none) 125 U, or or 1 placebo. (mild) at maximum improvement, frown, duration evaluated of effect, using and concurrent reporting investigator of treatment-emergent Penalties and subject Apply assessments. adverse events Secondary (TEAEs). endpoints included ≥1-grade severity Results: Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen. Conclusion: A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence.