| Infection Outcome | Abatacept (N=2653) | Placebo (N=1485) | Cumulative abatacept (N=7044) | |||
|---|---|---|---|---|---|---|
| p-y=2355 | p-y=1253 | p-y=21,330 | ||||
| N (%) | IR/100 p-y (95% CI) | N (%) | IR/100 p-y (95% CI) | N (%) | IR/100 p-y (95% CI) | |
| Opportunistic infections* | 4 (0.2) | 0.17 (0.05, 0.43) | 7 (0.5) | 0.56 (0.22, 1.15) | 45 (0.6)† | 0.21 (0.15, 0.28)† |
| Bronchopulmonary aspergillosis | 1 (<0.1) | 0.04 (0, 0.2) | 0 | 0 | 2 (<0.1) | 0.01 (0.00, 0.03) |
| Eye infection fungal | 1 (<0.1) | 0.04 (0, 0.2) | 0 | 0 | 3 (<0.1) | 0.01 (0.00, 0.04) |
| Gastrointestinal candidiasis | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | – | – |
| Fungal oesophagitis | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | 1 (<0.1) | 0.00 (0.00, 0.03) |
| Meningitis cryptococcal | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | – | – |
| Oesophageal candidiasis | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | 7 (0.1) | 0.03 (0.01, 0.07) |
| Pneumocystis jirovecii pneumonia | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | 1 (<0.1) | 0.00 (0.00, 0.03) |
| Pneumonia pseudomonal | 1 (<0.1) | 0.04 (0, 0.2) | 0 | 0 | 1 (<0.1) | 0.00 (0.00, 0.03) |
| Respiratory moniliasis | 0 | 0 | 1 (<0.1) | 0.08 (0, 0.4) | 2 (<0.1) | 0.01 (0.00, 0.03) |
| Tuberculosis | 1 (<0.1) | 0.04 (0, 0.2) | 1 (0.1) | 0.08 (0, 0.4) | 17 (0.2)‡ | 0.08 (0.05, 0.13)‡ |
| Herpes | ||||||
| Herpes simplex | 57 (2.1) | 2.5 (1.9, 3.2) | 22 (1.5) | 1.8 (1.1, 2.7) | 60 (0.9) | 0.28 (0.22, 0.37) |
| Herpes zoster | 44 (1.7) | 1.9 (1.4, 2.5) | 21 (1.4) | 1.7 (1.1, 2.6) | 284 (4) | 1.38 (1.22, 1.55) |
| Herpes virus infection | 5 (0.2) | 0.2 (0.1, 0.5) | 4 (0.3) | 0.3 (0.1, 0.8) | – | – |
*Except herpes; †n (%) for SAE was 19 and IR/100 p-y was 0.1 (95% CI 0.05, 0.14); ‡n (%) for SAE was 11 and IR/100 p-y was 0.05 (95% CI 0.03, 0.09); `–' indicates value is not available. SAE = serious AE.