Table 3.
Frequency of neutralizing antibody detection with onabotulinumtoxinA across multiple indications.
| Indication | Subjects, n | Post-Treatment NAb-Positive Subjects, n (%) [95% CI] | Post-Treatment NAb-Positive Subjects by Gender |
NAb-Positive Subjects at Study Exit, n (%) [95% CI] |
|
|---|---|---|---|---|---|
| Male, n (%) [95% CI] | Female, n (%) [95% CI] | ||||
| Cervical dystonia | 319 | 4 (1.3) [0, 2.5] |
2 (2.1) [0, 4.9] |
2 (0.9) [0, 2.1] |
1 (0.3) [0, 0.9] |
| Glabellar lines | 810 | 3 (0.4) [0, 0.8] |
0 (0.0) | 3 (0.4) [0, 0.9] |
0 (0.0) |
| Hyperhidrosis | 973 | 4 (0.4) [0, 0.8] |
1 (0.3) [0, 0.8] |
3 (0.5) [0, 1.1] |
2 (0.2) [0, 0.5] |
| Migraine | 501 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Adult poststroke spasticity | 406 | 2 (0.5) [0, 1.2] |
1 (0.5) [0, 1.4] |
1 (0.5) [0, 1.5] |
2 (0.5) [0, 1.2] |
| NDO | 589 | 8 (1.4) [0.4, 2.3] |
8 (3.3) [1.0, 5.5] |
0 (0.0) | 7 (1.2) [0.3, 2.1] |
| Lateral canthal lines | 915 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Overactive bladder | 956 | 3 (0.3) [0, 0.7] |
0 (0.0) | 3 (0.4) [0, 0.7] |
1 (0.1) [0, 0.3] |
| Pediatric lower limb spasticity | 299 | 3 (1.0) [0, 2.1] |
2 (1.3) [0, 3.1] |
1 (0.7) [0, 2.1] |
3 (1.0) [0, 2.1] |
| Pediatric NDO | 108 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Total | 5876 |
27 (0.5% of total)
[0.3, 0.6] |
14 (0.9)
[0.4, 1.4] |
13 (0.3)
[0.1, 0.5] |
16 (0.3% of total)
[0.1, 0.4] |
Indications are ordered by year of onabotulinumtoxinA approval (see Figure 1 for approval years). Abbreviations—F, female; M, male; NAb, neutralizing antibody; and NDO, neurogenic detrusor overactivity.