Table 3 Summary safety data from ASSURE [34]
Number of events (%) | Abatacept plus nonbiologic DMARD (n = 856) | Placebo plus nonbiologic DMARD (n = 418) | Abatacept plus biologic DMARD (n = 103) | Placebo plus biologic DMARD (n = 64) |
|---|---|---|---|---|
Death | 5 (0.6) | 4 (1.0) | 0 | 0 |
Total adverse events | 768 (89.7) | 360 (86.1) | 98 (95.1) | 57 (89.1) |
Serious adverse events | 100 (11.7) | 51 (12.2) | 23 (22.3) | 8 (12.5) |
Discontinuations because of adverse events | 43 (5.0) | 18 (4.3) | 9 (8.7) | 2 (3.1) |
Serious infection | 22 (2.6) | 7 (1.7) | 6 (5.8) | 1 (1.6) |
Neoplasm (benign/malignant) | 27 (3.2) | 16 (3.8) | 7 (6.8) | 1 (1.6) |