Days 1–197 | Days 1–365 | ||||
Abatacept + MTX (n = 156) | Placebo + MTX (n = 110) | Inflixima + MTX (n = 165) | Abatacept + MTX (n = 156) | Infliximab + MTX (n = 165) | |
n (%) | n (%) | n (%) | n (%) | n (%) | |
Total patients with SAEs | 8 (5.1) | 13 (11.8) | 19 (11.5) | 15 (9.6) | 30 (18.2) |
Infections and infestations | 2 (1.3) | 3 (2.7) | 7 (4.2) | 3 (1.9) | 14 (8.5) |
Pneumonia | 2 (1.3) | 0 | 2 (1.2) | 2 (1.3) | 3 (1.8) |
Sinusitis | 1 (0.6) | 0 | 0 | 1 (0.6) | 0 |
Postoperative wound infection | 0 | 1 (0.9) | 0 | 0 | 1 (0.6) |
Soft tissue abscess | 0 | 1 (0.9) | 0 | 0 | 0 |
Infective bursitis | 0 | 1 (0.9) | 0 | 0 | 0 |
Bronchitis | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Cellulitis | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Gastroenteritis | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Herpes zoster | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Lung infection pseudomonal | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Pneumocystis jiroveci pneumonia | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) |
Infection skin ulcer | 0 | 0 | 0 | 1 (0.6) | 0 |
Encephalitis herpetic | 0 | 0 | 0 | 0 | 1 (0.6) |
Erysipelas | 0 | 0 | 0 | 0 | 1 (0.6) |
Lobar pneumonia | 0 | 0 | 0 | 0 | 1 (0.6) |
Peritoneal tuberculosis | 0 | 0 | 0 | 0 | 1 (0.6) |
Pulmonary tuberculosis | 0 | 0 | 0 | 0 | 1 (0.6) |
Septic shock | 0 | 0 | 0 | 0 | 1 (0.6) |
MTX, methotrexate; SAE, serious adverse event.