Summary of adverse events reported in the double-blind (DB) period and longterm extension (LTE). Table includes data from patients included in the anti-tumor necrosis factor failure substudy. Safety data are based on all patients who received at least 1 dose of abatacept (ABA) in the intent-to-treat population.
| DB Period SC ABA + MTX, n = 744 | DB Period IV ABA + MTX, n = 731 | LTE SC ABA + MTX, n = 1372 | ||||
|---|---|---|---|---|---|---|
| Patients with Event, n (%) | IR (95% CI) | Patients with Event, n (%) | IR (95% CI) | Patients with Event, n (%) | IR (95% CI) | |
| Deaths | 1 (0.1) | 0.29 (0.01, 1.64) | 5 (0.7) | 1.51 (0.49, 3.53) | 21 (1.5) | 0.71 (0.44, 1.09) |
| SAE | 31 (4.2) | 9.02 (6.31, 12.90) | 36 (4.9) | 11.14 (8.04, 15.44) | 238 (17.3) | 8.76 (7.71, 9.95) |
| Discontinued owing to SAE | 9 (1.2) | 2.66 (1.22, 5.06) | 14 (1.9) | 4.25 (2.32, 7.13) | 42 (3.1) | 1.42 (1.03, 1.92) |
| AE | 503 (67.6) | 279.35 (255.46, 304.86) | 478 (65.4) | 265.67 (242.38, 290.59) | 1147 (83.6) | 107.73 (101.59, 114.15) |
| Discontinued owing to AE | 16 (2.2) | 4.75 (2.72, 7.72) | 25 (3.4) | 7.62 (4.93, 11.26) | 56 (4.1) | 1.90 (1.43, 2.47) |
| Infections | 237 (31.9) | 84.54 (74.12, 96.01) | 227 (31.1) | 82.92 (72.48, 94.44) | 803 (58.5) | 44.80 (41.76, 48.01) |
| Serious infections | 5 (0.7) | 1.48 (0.62, 3.56) | 10 (1.4) | 3.05 (1.64, 5.67) | 50 (3.6) | 1.72 (1.30, 2.27) |
| Malignancies | 2 (0.3) | 0.59 (0.15, 2.36) | 5 (0.7) | 1.52 (0.63, 3.65) | 35 (2.6) | 1.19 (0.86, 1.66) |
| Autoimmune events | 6 (0.8) | 1.78 (0.80, 3.96) | 6 (0.8) | 1.83 (0.82, 4.07) | 38 (2.8) | 1.31 (0.95, 1.79) |
AE: adverse event; IV: intravenous; MTX: methotrexate; SAE: serious adverse event; SC: subcutaneous; IR: incidence rates.