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.