Table 2.
Proportion of responders at cycle 1 day 29 by the IRA of photographs and SGA score of glabellar lines at maximum frown
| Assessment | Treatment groupa | |||
|---|---|---|---|---|
| Group A | Group B | Group C | Group D | |
| N = 294 | N = 60 | N = 94 | N = 19 | |
| Responder by IRA of photographs | ||||
| Active treatment compared with placebo | ||||
| Adjusted proportion of responders, % (95% CI) | 99.1 (95.0; 99.8) | 25.3 (11.6; 46.7) | 94.4 (85.0; 98.1) | 31.5 (9.4; 67.1) |
| Difference (95% CI) aboBoNT-A to matching placebo | – | 73.8 (59.1; 88.4)b | – | – |
| Difference (95% CI) active comparator to matching placebo | – | – | – | 62.9 (34.9; 91.0) |
| AboBoNT-A compared with active comparator | ||||
| Adjusted proportion of responders, % (95% CI) | 97.1 (92.4; 98.9) | – | 98.7 (92.9; 99.8) | – |
| Difference (95% CI) aboBoNT-A to active comparator | – | – | −1.5 (−5.3; 2.2) | – |
| Responder by SGA score | ||||
| Active treatment compared with placebo | ||||
| Adjusted proportion of responders, % (95% CI) | 85.1 (80.2; 88.9) | 1.3 (0.2; 9.0) | 85.2 (74.4; 91.9) | 2.4 (0.2; 23.3) |
| Difference (95% CI) aboBoNT-A to matching placebo | – | 83.7 (78.7; 88.7)b | – | – |
| Difference (95% CI) active comparator to matching placebo | – | – | – | 82.8 (72.9; 92.7) |
| AboBoNT-A compared to active comparator | ||||
| Adjusted proportion of responders, % (95% CI) | 85.4 (80.5; 89.2) | – | 85.4 (76.6; 91.2) | – |
| Difference (95% CI) aboBoNT-A to active comparator | – | – | −0.0 (−8.2; 8.2) | – |
aTreatment group in cycle 1. bp < 0.0001
Data are shown for the mITT population. Treatment difference and 95% CI s for the treatment comparisons were based on separate multivariate logistic regression models, with treatment group, stratification factors, and center as explanatory variables, and responder (yes or no) as response variable. A responder was defined as having a severity grade of moderate (2) or severe (3) at maximum frown at baseline (day 1), and a severity grade of none (0) or mild (1) at maximum frown at day 29. AboBoNT-A = abobotulinumtoxinA; CI = confidence interval; Group A = patients who received aboBoNT-A 50 U; Group B = patients who received matching aboBoNT-A placebo; Group C = patients who received onaBoNT-A 20 U; Group D = patients who received matching onaBoNT-A placebo; IRA = independent reviewer’s assessment; mITT = modified intent-to-treat; onaBoNT-A = onabotulinumtoxinA; SGA = subject’s global assessment; U = unit