Table 2.
AMPLE: SC abatacept versus SC adalimumab - 1-year safety summary.
| Safety variable |
n (%) |
|||
|---|---|---|---|---|
| One-year analysis | Two-year analysis | |||
| SC abatacept + MTX (n = 318) | SC adalimumab + MTX (n = 328) | SC abatacept + MTX (n = 318) | SC adalimumab + MTX (n = 328) | |
| AEs | 280 (88.1) | 283 (86.3) | 295 (92.8) | 300 (91.5) |
| SAEs | 32 (10.1) | 30 (9.1) | 44 (13.8) | 54 (16.5) |
| Discontinuations due to AEs | 11 (3.5) | 20 (6.1) | 12 (3.8) | 31 (9.5) |
| Discontinuations due to SAEs | 4 (1.3) | 10 (3.0) | 5 (1.6) | 16 (4.9) |
| Serious infections and infestations | 7 (2.2) | 9 (2.7) | 12 (3.8) | 19 (5.8) |
| Discontinuations due to serious infections | 0 | 5 (1.5) | 0 | 9 (2.7) |
| Malignancies | 5 (1.6) | 4 (1.2) | 7 (2.2) | 7 (2.1) |
| Autoimmune events | 10 (3.1) | 4 (1.2) | 12 (3.8) | 6 (1.8) |
| Local injection-site reactions | 12 (3.8) | 30 (9.1) | 13 (4.1) | 34 (10.4) |
| Deaths | 1 (0.3) | 0 | 1 (0.3) | 1 (0.3) |
AE, adverse event; MTX, methotrexate; SAE, serious adverse event; SC, subcutaneous.