74% with a ≥1-grade improvement at maximum frown. Subject assessments (SSA) showed comparable results (Figure 2 and Figure 3).
Glabellar Line Severity Improvement
The composite 2-grade GL responder rate at maximum frown at month 1 (primary endpoint) was significantly higher in the aboBoNT-A group, 65.8% (95% CI: 59.49–72.03), than in the placebo group, 0.0% (95% CI: 0.00–4.68), P<0.001 in the ITT population. Results were similar in the PP population (data not shown).
The highest none-or-mild GL responder rate at maximum frown was 92% of subjects, reached at week 2 in the subject assessments (SSA) and at month 1 in the investigator assessments (ILA). Both scales showed statistically significant, higher none-or-mild severity responder rates for aboBoNT-A compared to placebo from day 2 through month 6 (P<0.001) (Figure 2). In the placebo group, none-or-mild rates were ≤3% on the ILA scale and ≤10% on the SSA scale throughout the 6 month study.
A ≥1-grade improvement from baseline in GL severity at maximum frown was achieved in all subjects treated with aboBoNT-A at month 1 in the investigator assessments (ILA) and in 95% in the subject assessments (SSA). The ≥1-grade responder rates at maximum frown remained significantly higher for the aboBoNT-A group than placebo (P<0.001) throughout 6 months after treatment, both in the ILA and SSA assessments (Figure 3). At month 6, a ≥1-grade improvement in GL severity was reported in 46% of subjects on the ILA scale and 56% of subjects on the SSA scale in the aboBoNT-A group, compared to 15% (ILA) and 25% (SSA) for placebo.
Figure 4 shows treatment results at maximum frown at 1 and 6 months after treatment with aboBoNT-A.
GL severity at rest was improved in 72% of subjects at 1 month after aboBoNT-A treatment versus in 16% for placebo, as assessed by the investigators (ILA). The ≥1-grade improvement responder rates at rest were significantly higher for aboBoNT-A than placebo at all post-treatment visits through month 6 (P<0.001, data not shown). At month 6, 51% (aboBoNT-A) versus 24% (placebo) had a ≥1-grade improvement from baseline at rest.
Duration of Severity Improvement
For subjects who achieved a score of 0 or 1 on both the ILA and the SSA scales concurrently at maximum frown after aboBoNTA- treatment, the median time to loss of this score on both scales was 163 days (5.4 months) after injection, based on the Kaplan- Meier analyses. At 6 months after injection, >50% of the subjects who achieved a score of 0 or 1 had still not returned to baseline scores, ie, retained at least a 1-grade improvement on one or both scales.
Global Aesthetic Improvement
At peak response (month 1), 99% of subjects in the aboBoNT-A group assessed themselves as aesthetically improved in the GL area in the GAIS assessments. Aesthetic improvement was sustained in 94% through month 3, 80% through month 4 and 60% through month 6. In the placebo group, the GAIS responder rate was ≤13% throughout month 6 (Figure 5).
Subject Satisfaction Questionnaire
From month 1 to month 6, ≥91% of subjects in the aboBoNT-A group were satisfied with the aesthetic outcome of their treatment, ≥90% responded that they appeared refreshed, ≥84% were
