Summary of antidrug antibody status: safety analysis set
| F-F-F N=216 n (%) | F-RP-F N=108 n (%) | RP-F-F N=108 n (%) | RP-RP-F N=213 n (%) | |
|---|---|---|---|---|
| Period 2, Week 0 | ||||
| Total | 216 | 108 | 108 | 212 |
| Positive | 133 (61.6) | 69 (63.9) | 67 (62.0) | 123 (58.0) |
| Week 12 | ||||
| Total | 202 | 103 | 103 | 202 |
| Positive | 107 (53.0) | 60 (58.3) | 54 (52.4) | 101 (50.0) |
| Week 24 | ||||
| Total | 197 | 100 | 96 | 199 |
| Positive | 99 (50.3) | 58 (58.0) | 47 (49.0) | 100 (50.3) |
| Period 3, Week 30* | ||||
| Total | 187 | 100 | 93 | 190 |
| Positive | 97 (51.9) | 61 (61.0) | 42 (45.2) | 98 (51.6) |
| Week 54 | ||||
| Total | 181 | 93 | 89 | 181 |
| Positive | 103 (56.9) | 49 (52.7) | 41 (46.1) | 77 (42.5) |
| Week 76 | ||||
| Total | 176 | 90 | 81 | 174 |
| Positive | 90 (51.1) | 49 (54.4) | 39 (48.1) | 74 (42.5) |
| Week 80 | ||||
| Total | 173 | 87 | 80 | 170 |
| Positive | 91 (52.6) | 48 (55.2) | 37 (46.3) | 72 (42.4) |
*Week 30 is end of Period 2.
Percentages are based on the number of patients in the safety analysis set with an assay result obtained at each planned relative time (Week).
F, FKB327; N, number of patients in the safety analysis set; n, total number of patients with observation; RP, reference product.