Incidence of ADA and NAbs at weeks 24–52 in the safety set
| Timepoint | Parameter | Result | SB11 (n=350) n/n’ (%) | RBZ (n=354) n/n’ (%) | P value* |
| Overall cumulative incidence of ADA | |||||
| Up to week 52 | ADA | Positive | 14/330 (4.2) | 18/327 (5.5) | – |
| Negative | 312/330 (94.5) | 308/327 (94.2) | – | ||
| Inconclusive† | 4/330 (1.2) | 1/327 (0.3) | – | ||
| Incidence of ADA and NAb at each visit | |||||
| Week 24 | ADA | Positive | 7/294 (2.4) | 2/290 (0.7) | 0.18‡ |
| NAb | Positive | 0/7 (0.0) | 1/2 (50.0) | – | |
| Week 36 | ADA | Positive | 8/270 (3.0) | 5/274 (1.8) | 0.38§ |
| NAb | Positive | 2/8 (25.0) | 0/5 (0.0) | – | |
| Week 52 | ADA | Positive | 9/257 (3.5) | 12/267 (4.5) | 0.56§ |
| NAb | Positive | 1/9 (11.1) | 0/12 (0.0) | – | |
*P values calculated by using χ² or Fisher’s exact test to compare the distribution of positivity between treatment groups.
†The result was considered inconclusive in cases of positive ADA result at baseline and either negative ADA result or positive ADA result with equal or lower titre at the subsequent timepoint.
‡Two-sided p value was estimated based on Fisher’s exact test, if expected frequency in one cell was less than 5.
§Two-sided p value was estimated based on χ² test, if expected frequency in all cells was greater or equal to 5.
ADA, antidrug antibody; N, total number of participants; n, number of participants with the specified assessment result; n’, number of participants with available assessment results at each visit (percentages are based on n’); NA, not available; NAb, neutralising antibody; RBZ, reference ranibizumab.