Table 2.
Safety summary (ITT population)*
| SC abatacept + MTX (n = 736) | IV abatacept + MTX (n = 721) | |
|---|---|---|
| Deaths | 2 (0.3) | 5 (0.7) |
| Serious AEs | 31 (4.2) | 35 (4.9) |
| Discontinued due to serious AEs | 8 (1.1) | 14 (1.9) |
| AEs | 493 (67.0) | 470 (65.2) |
| Discontinued due to AE | 15 (2.0) | 25 (3.5) |
| Infections | 234 (31.8) | 221 (30.7) |
| Serious infections | 5 (0.7) | 10 (1.4) |
| Malignancies | 3 (0.4) | 5 (0.7) |
| Autoimmune events | 7 (1.0) | 6 (0.8) |
| SC injection site reactions | 19 (2.6) | 18 (2.5) |
| Hematoma | 4 (0.5) | 4 (0.6) |
| Pruritus | 6 (0.8) | 1 (0.1) |
| Erythema | 5 (0.7) | 1 (0.1) |
| Pain | 1 (0.1) | 4 (0.6) |
| Papule | 1 (0.1) | 3 (0.4) |
| Reaction | 1 (0.1) | 3 (0.4) |
| Rash | 2 (0.3) | 1 (0.1) |
| Urticaria | 0 | 2 (0.3) |
| Other† | 4 (0.5) | 0 |
*
Values are the number (%) of events. Safety data are based on all patients who received at least 1 dose of abatacept. Given the double-dummy study design, patients in the SC abatacept–treated group received IV placebo and patients in the IV abatacept–treated group received SC placebo. AEs = adverse events (see Table 1 for other definitions).
†
Individual SC injection site reactions not reported in more than 1 patient overall.