Table 1.
Comparative ATA titers toward the designated SB5 and ADL lots among anti-ADL ATA+ and ATA– sera from patients with inflammatory bowel disease.
| SB5 |
ADL |
|||
|---|---|---|---|---|
| Sera type | Lot A | Lot B | Lot A | Lot B |
| ATA+, mean (SD) | 21.31 (16.96) | 21.26 (17.05) | 21.30 (17.07) | 20.99 (16.88) |
| ADL lot A, p value* for difference between lots | NS | NS | – | – |
| ADL lot B, p value for difference between lots | NS | 0.0427 | – | – |
| ATA–, mean (SD) | 0.84 (0.75) | 0.82 (0.74) | 0.72 (0.70) | 0.71 (0.72) |
| ADL lot A, p value* for difference between lots | <0.05 | <0.05 | – | – |
| ADL lot B, p value for difference between lots | <0.05 | <0.05 | – | – |
*
If normality was accepted (Shapiro-Wilk test), parametric methods were used for analysis; mean of difference between two lots and p value by paired t test were calculated.
ADL, reference adalimumab; ATA, antidrug antibody to adalimumab; NS, not significant.