Events During the Double-Blind, Placebo-Controlled Period
| Abatacept (N=2653) | Placebo (N=1485) | |||
|---|---|---|---|---|
| Outcome | N (%) | IR (95% CI) | N (%) | IR (95% CI) |
| Deaths | 12 (0.5) | 0.5 (0.3, 0.9) | 12 (0.8) | 1.0 (0.5, 1.7) |
| SAEs | 331 (12.5) | 14.8 (13.3, 16.5) | 174 (11.7) | 14.6 (12.5, 17.0) |
| Discontinued due to SAEs | 68 (2.6) | 22 (1.5) | ||
| Infections | 1440 (54.3) | 91.3 (86.7, 96.2) | 761 (51.6) | 90.8 (84.4, 97.4) |
| Serious infections | 41 (1.5) | 1.7 (1.2, 2.3) | 16 (1.1) | 1.2 (0.7, 2.0) |
| Solid organ malignancies | 26 (1.0) | 1.11 (0.7, 1.6) | 12 (0.8) | 1.0 (0.5, 1.7) |
| NMSC (combined) | 14 (0.5) | 0.6 (0.3, 1.0) | 5 (0.3) | 0.4 (0.1, 0.9) |
| Autoimmune diseases | 198 (7.5) | 8.5 (7.3, 9.8) | 115 (7.7) | 9.2 (7.6, 11.1) |
| COPD | 13 (0.5) | 0.6 (0.3, 1.0) | 2 (0.1) | 0.2 (0.0, 0.6) |