Canakinumab pooled dose | Placebo | ||||
---|---|---|---|---|---|
Low dose | Intermediate dose | Medium dose | High dose | ||
N = 20 | N = 247 | N = 268 | N = 137 | N = 354 | |
Infections | |||||
n (%) | 4 (20.0) | 54 (21.9) | 40 (14.9) | 30 (21.9) | 49 (13.8) |
IR (%) | 4.41 | 4.05 | 5.13 | 4.02 | 3.17 |
Hypersensitivity/allergy | |||||
n (%) | 0 | 9 (3.6) | 9 (3.4) | 6 (4.4) | 14 (4.0) |
IR (%) | 0 | 0.59 | 1.02 | 0.70 | 0.84 |
Thrombocytopenia | |||||
n (%) | 1 (5.0) | 7 (2.8) | 5 (1.9) | 4 (2.9) | 4 (1.1) |
IR (%) | 1.04 | 0.46 | 0.56 | 0.46 | 0.23 |
Hypertension | |||||
n (%) | 0 | 5 (2.0) | 3 (1.1) | 3 (2.2) | 6 (1.7) |
IR (%) | 0 | 0.32 | 0.33 | 0.35 | 0.35 |
Major adverse cardiovascular events (MACE) | |||||
n (%) | 0 | 3 (1.2) | 4 (1.5) | 2 (1.5) | 9 (2.5) |
IR (%) | 0 | 0.19 | 0.44 | 0.23 | 0.53 |
Hepatic disorders | |||||
n (%) | 0 | 1 (0.4) | 2 (0.7) | 6 (4.4) | 2 (0.6) |
IR (%) | 0 | 0.06 | 0.22 | 0.70 | 0.12 |
Vertigo | |||||
n (%) | 0 | 1 (0.4) | 5 (1.9) | 4 (2.9) | 6 (1.7) |
IR (%) | 0 | 0.06 | 0.56 | 0.46 | 0.3 |
Injection-site reactions | |||||
n (%) | 0 | 0 | 2 (0.7) | 0 | 2 (0.6) |
IR (%) | 0 | 0 | 0.22 | 0 | 0.12 |
Hypoglycaemia | |||||
n (%) | 0 | 0 | 2 (0.7) | 0 | 1 (0.3) |
IR (%) | 0 | 0 | 0.22 | 0 | 0.06 |
Changes in renal function | |||||
n (%) | 0 | 1 (0.4) | 1 (0.4) | 0 | 0 |
IR (%) | 0 | 0.06 | 0.11 | 0 | 0 |
Lymphoid organ toxicity | |||||
n (%) | 0 | 0 | 1 (0.4) | 0 | 0 |
IR (%) | 0 | 0 | 0.11 | 0 | 0 |
Malignancies | |||||
n (%) | 0 | 0 | 0 | 1 (0.7) | 0 |
IR (%) | 0 | 0 | 0 | 0.11 | 0 |
Neutropenia | |||||
n (%) | 0 | 1 (0.4) | 0 | 0 | 0 |
IR (%) | 0 | 0.06 | 0 | 0 | 0 |