Table 6.
Comparison of safety outcomes and the AFFIRM trial
| Reference | Discontinuations | Hypersensitivity reactions | Neutralizing antibodies |
|---|---|---|---|
| Putzki et al. [8] | 8 (8.2%) | 2 (2.1%)a | 4 (4.1%)b |
| Oturia et al. [9] | 27 (12%) | 9 (3.8%) | 7 (2.9%) |
| Sangalli et al. [10] | 34 (12%) | 18 (6.3%) | 19 (6.6%) |
| Outteryck et al. [12] | 35 (9.1%) | 15 (3.9%) | 5 (1.3%)b |
| Prosperini et al. [11] | 31 (16.3%) | 4 (2.1%)a | 19 (10%)c |
| Putzki et al. [16] | 10 (12%) | 2 (2.4%)a | 6 (7.1%)b |
| Piehl et al. [17] | 116 (10.4%) | – | 39 (3.9%) |
| Fernández et al. [18] | 13 (16.8%) | 1 (1.3%) | 9 (11.7%) |
| Horga et al. [19] | 16 (14.4%) | 5 (4.5%) | – |
| Fernández et al.d | 176 (14%) | 46 (3.6%) | 34 (3.1%)c |
| AFFIRM/Polman et al. [4] | 3.8% (natalizumab) | 9% (natalizumab) | 57 (9%) |
| 4.8% (placebo) | 4% (placebo) | – |
aOnly reported if leading to discontinuation
bPersistent and leading to discontinuation
cOnly patients with suspected antibodies were tested for neutralizing antibodies. Nevertheless the percentage is calculated with respect to the total population on the assumption that antibodies were only tested in the event of clinical suspicion
dThis study