Table 3.
Overall incidence of antidrug antibodies and neutralizing antibodies
| YLB113 50 mg | RP 50 mg | |||||||
|---|---|---|---|---|---|---|---|---|
| Total reportable | ADA positive | NAb positive | Total reportable | ADA positive | NAb positive | |||
| N | n | n (%) | n (%) | N | n | n (%) | n (%) | |
| Stage A | 264 | 264 | 2 (0.8) | 0 | 260 | 260 | 21 (8.1) | 2 (0.8) |
| Stage B | 236 | 234 | 0 | 0 | 235 | 235 | 3 (1.3) | 0 |
| Stage C | 10 | 10 | 0 | 0 | 8 | 8 | 1 (12.5) | 0 |
| Long-term immunogenicity | 236 | 236 | 2 (0.8) | 0 | 235 | 235 | 22 (9.4) | 1 (0.4) |
% indicates percentage of subjects with sampling results “Positive” calculated relative to the total reportable number of subjects
ADA antidrug antibody, N number of subjects in the analysis set for each column, n number of subjects in each particular category, NAb neutralizing antibody, RP etanercept reference product, total reportable total number of subjects in the analysis set with ADA data