Canakinumab pooled dose | Placebo | ||||
---|---|---|---|---|---|
Low dose | Intermediate dose | Medium dose | High dose | ||
N = 20 | N = 247 | N = 268 | N = 137 | N = 354 | |
Any AEs | |||||
n (%) | 10 (50.0) | 107 (43.3) | 103 (38.4) | 67 (48.9) | 134 (37.9) |
IR (%) | 16.31 | 10.28 | 16.45 | 12.14 | 11.45 |
Discontinuations due to any AEs | |||||
n (%) | 1 (5.0) | 1 (0.4) | 0 | 2 (1.5) | 1 (0.3) |
IR (%) | 0.99 | 0.06 | 0.23 | 0.06 | |
Any serious AEs | |||||
n (%) | 0 | 4 (1.6) | 5 (1.9) | 8 (5.8) | 10 (2.8) |
IR (%) | 0 | 0.26 | 0.55 | 0.94 | 0.58 |
Deaths | |||||
n (%) | 0 | 0 | 0 | 0 | 0 |
AEs by primary SOCs (occurring in ≥5% of patients in any group) | |||||
Infections and infestations | |||||
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 |
Musculoskeletal and connective tissue disorders | |||||
n (%) | 1 (5.0) | 22 (8.9) | 14 (5.2) | 11 (8.0) | 27 (7.6) |
IR (%) | 1.03 | 1.48 | 1.62 | 1.33 | 1.65 |
Gastrointestinal disorders | |||||
n (%) | 1 (5.0) | 12 (4.9) | 17 (6.3) | 12 (8.8) | 21 (5.9) |
IR (%) | 1.04 | 0.80 | 1.98 | 1.44 | 1.26 |
Cardiac disorders | |||||
n (%) | 1 (5.0) | 8 (3.2) | 4 (1.5) | 3 (2.2) | 12 (3.4) |
IR (%) | 1.04 | 0.53 | 0.44 | 0.35 | 0.71 |
Eye disorders | |||||
n (%) | 3 (15.0) | 5 (2.0) | 6 (2.2) | 2 (1.5) | 7 (2.0) |
IR (%) | 3.40 | 0.33 | 0.67 | 0.23 | 0.41 |
Renal and urinary disorders | |||||
n (%) | 1 (5.0) | 5 (2.0) | 5 (1.9) | 5 (3.6) | 3 (0.8) |
IR (%) | 1.04 | 0.32 | 0.55 | 0.58 | 0.17 |
Investigations | |||||
n (%) | 0 | 12 (4.9) | 13 (4.9) | 16 (11.7) | 15 (4.2) |
IR (%) | 0.79 | 1.50 | 1.96 | 0.89 | |
Skin and subcutaneous tissue disorders | |||||
n (%) | 0 | 10 (4.0) | 11 (4.1) | 7 (5.1) | 16 (4.5) |
IR (%) | 0.65 | 1.25 | 0.83 | 0.95 |