Table 2.
Immunogenicity summary
End of period II (Withdrawal phase) | End of period III (Reintroduction phase)* | |||
---|---|---|---|---|
Period II SC abatacept (n=40) | Period II SC placebo (n=80) | Period II SC abatacept†(n=40) | Period II SC placebo‡(n=79) | |
Anti-abatacept, n/N (%) | 0/37 (0) | 1/71 (1.4) | 0/38 (0) | 0/73 (0) |
95% CI | – | 0.0 to 4.1 | – | – |
Anti-CTLA4-T, n/N (%) | 0/38 (0) | 6/73 (8.2) | 1/38 (2.6) | 2/73 (2.7) |
95% CI | – | 1.9 to 14.5 | 0.0 to 7.7 | 0.0 to 6.5 |
Total, n/N (%) | 0/38 (0) | 7/73 (9.6) | 1/38 (2.6) | 2/73 (2.7) |
95% CI | – | 2.8 to 16.3 | 0.0 to 7.7 | 0.0 to 6.5 |
Estimate of difference, % (95% CI) | 9.59 (0.83 to 18.34) | 0.11 (–8.21 to 8.43) | ||
p Value | 0.119 | – |
All patients received SC abatacept during period III, with results shown by period II treatment group.
Patients received intravenous placebo loading at the start of period III.
Patients received intravenous abatacept or intravenous placebo (1:1 ratio) loading at the start of period III.
SC, subcutaneous.