Table 1 Patient exposure and demographic and baseline characteristics by pooled dose
Canakinumab pooled dose | ||||||
|---|---|---|---|---|---|---|
Low dose | Intermediate dose | Medium dose | High dose | Placebo | Total | |
N = 20 | N = 247 | N = 268 | N = 137 | N = 354 | N = 1026 | |
Duration of exposure (months) | 3.00 ± 0.0 | 7.29 ± 3.057 | 4.93 ± 2.985 | 6.79 ± 3.119 | 5.82 ± 3.250 | 6.02 ± 3.235 |
≥3, n (%) | 20 (100) | 247 (100) | 268 (100) | 137 (100) | 354 (100) | 1026 (100) |
≥4, n (%) | 0 | 185 (74.9) | 89 (33.2) | 91 (66.4) | 172 (48.6) | 537 (52.3) |
≥6, n (%) | 0 | 179 (72.5) | 87 (32.5) | 90 (65.7) | 166 (46.9) | 522 (50.9) |
≥8, n (%) | 0 | 116 (47.0) | 54 (20.1) | 56 (40.9) | 110 (31.1) | 336 (32.7) |
≥10, n (%) | 0 | 37 (15.0) | 19 (7.1) | 15 (10.9) | 35 (9.9) | 106 (10.3) |
Subject months of exposure | 60.00 | 1800.61 | 1320.22 | 929.68 | 2067.64 | 6178.14 |
Duration of follow-up (months) | 5.08 ± 1.426 | 6.34 ± 2.243 | 3.40 ± 3.056 | 6.43 ± 1.691 | 4.93 ± 2.898 | 5.07 ± 2.885 |
<1, n (%) | 1 (5.0) | 2 (0.8) | 111 (41.4) | 0 | 73 (20.6) | 187 (18.2) |
≥1, n (%) | 19 (95.0) | 245 (99.2) | 157 (58.6) | 137 (100) | 281 (79.4) | 839 (81.8) |
≥2, n (%) | 18 (90.0) | 231 (93.5) | 115 (42.9) | 137 (100) | 252 (71.2) | 753 (73.4) |
≥3, n (%) | 18 (90.0) | 228 (92.3) | 114 (42.5) | 136 (99.3) | 251 (70.9) | 747 (72.8) |
≥4, n (%) | 18 (90.0) | 227 (91.9) | 109 (40.7) | 135 (98.5) | 247 (69.8) | 736 (71.7) |
≥6, n (%) | 0 | 123 (49.8) | 59 (22.0) | 62 (45.3) | 115 (32.5) | 359 (35.0) |
≥8, n (%) | 0 | 40 (16.2) | 22 (8.2) | 20 (14.6) | 40 (11.3) | 122 (11.9) |
≥10, n (%) | 0 | 12 (4.9) | 7 (2.6) | 5 (3.6) | 15 (4.2) | 39 (3.8) |
Subject months of follow-up | 101.58 | 1565.43 | 910.69 | 881.38 | 1744.57 | 5203.65 |
Demographic variable | ||||||
Age (years) | 53.9 ± 9.07 | 54.4 ± 9.53 | 55.7 ± 10.05 | 54.9 ± 10.14 | 55.5 ± 9.65 | 55.2 ± 9.78 |
<65, n (%) | 17 (85.0) | 206 (83.4) | 210 (78.4) | 109 (79.6) | 285 (80.5) | 827 (80.6) |
≥65, n (%) | 3 (15.0) | 41 (16.6) | 58 (21.6) | 28 (20.4) | 69 (19.5) | 199 (19.4) |
Sex, n (%) | ||||||
Male | 10 (50.0) | 127 (51.4) | 138 (51.5) | 81 (59.1) | 203 (57.3) | 559 (54.5) |
Female | 10 (50.0) | 120 (48.6) | 130 (48.5) | 56 (40.9) | 151 (42.7) | 467 (45.5) |
Race, n (%) | ||||||
Caucasian | 19 (95.0) | 134 (54.3) | 168 (62.7) | 81 (59.1) | 218 (61.6) | 620 (60.4) |
Black | 1 (5.0) | 12 (4.9) | 8 (3.0) | 5 (3.6) | 14 (4.0) | 40 (3.9) |
Asian | 0 | 81 (32.8) | 77 (28.7) | 41 (29.9) | 97 (27.4) | 296 (28.8) |
Others | 0 | 20 (8.1) | 15 (5.7) | 10 (7.3) | 25 (7.0) | 70 (6.9) |
BMI (kg/m2), n (%) | ||||||
<30 | 9 (45.0) | 131 (53.0) | 115 (42.9) | 72 (52.6) | 183 (51.7) | 510 (49.7) |
≥30 | 11 (55.0) | 116 (47.0) | 153 (57.1) | 65 (47.4) | 171 (48.3) | 516 (50.3) |
HbA1c (%) | 7.6 ± 0.79 | 7.5 ± 0.80 | 7.1 ± 0.74 | 7.6 ± 0.76 | 7.4 ± 0.85 | 7.4 ± 0.81 |
FPG (mmol/L) | 8.8 ± 1.84 | 7.9 ± 1.87 | 7.7 ± 1.86 | 8.1 ± 1.56 | 8.0 ± 1.87 | 7.9 ± 1.83 |
Duration of type 2 diabetes (years) | 5.0 ± 3.62 | 4.6 ± 4.64 | 7.0 ± 6.89 | 4.8 ± 4.70 | 5.6 ± 5.45 | 5.5 ± 5.59 |
Subjects with IGT, n | 0 | 0 | 28 | 0 | 26 | 54 |
Diabetes complications, n (%) | ||||||
Retinopathy | NA | 3 (1.6) | 10 (4.6) | 1 (1.1) | 8 (3.3) | 22 (3.0) |
Neuropathy | NA | 25 (13.3) | 27 (12.4) | 11 (12.0) | 19 (7.8) | 82 (11.1) |
Nephropathy | NA | 2 (1.1) | 8 (3.7) | 4 (4.3) | 7 (2.9) | 21 (2.8) |
Use of statins, n (%) | 2 (10.0) | 64 (25.9) | 104 (38.8) | 32 (23.4) | 87 (24.6) | 289 (28.2) |