Table 1.
Safety variable |
n (%) |
|
---|---|---|
SC abatacept + MTX (n = 736) | IV abatacept + MTX (n = 736) | |
AEs | 493 (67.0) | 470 (65.2) |
SAEs | 31 (4.2) | 35 (4.9) |
Discontinuations due to AEs | 15 (2.0) | 25 (3.5) |
Discontinuations due to SAEs | 8 (1.1) | 14 (1.9) |
Infections | 234 (31.8) | 221 (30.7) |
Serious infections | 5 (0.7) | 10 (1.4) |
Discontinuations due to serious infections | 0 | 4 (0.6) |
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) |
Deaths | 2 (0.3) | 5 (0.7) |
AE, adverse event; IV, intravenous; MTX, methotrexate; SAE, serious adverse event; SC, subcutaneous.