Table 1.
Median (interquartile range) cytokine and chemokine values and percentages of patients with a value below the limit of detection at randomization and the second time point.
| Randomization |
Month 2 (Month 1 for IL6-E) |
|||||
|---|---|---|---|---|---|---|
| Cytokines, pg/ml | DC arm | VS arm | P-valuea | DC arm | VS arm | P-valuea |
| IL-1β | ||||||
| Median (range) | 0.64 (0.02, 39.22) | 0.77 (0.02, 19.30) | 0.60 (0.02, 13.32) | 0.67 (0.02, 10.98) | ||
| n (%) with value below limit | 22 (11.0%) | 24 (12.0%) | 0.50 | 18 (9.0%) | 21 (10.6%) | 0.65 |
| IL-2 | ||||||
| Median (range) | 3.19 (0.02, 219.9) | 4.27 (0.01, 145.1) | 2.47 (0.01, 65.32) | 3.56 (0.08, 81.04) | ||
| n (%) with value below limit | 9 (4.5%) | 9 (4.5%) | 1.00 | 9 (4.5%) | 11 (5.5%) | 0.64 |
| IL6-M | ||||||
| Median (range) | 4.72 (0.02, 136.1) | 5.54 (0.06, 100.2) | 5.43 (0.05, 139.1) | 5.74 (0.09, 147.1) | ||
| n (%) with value below limit | 2 (1.0%) | 1 (0.5%) | 0.56 | 1 (0.5%) | 2 (1.0%) | 0.56 |
| IL6-E | ||||||
| Median (range) | 2.37 (0.16, 14.79) | 2.54 (0.27, 88.63) | 3.52 (0.45, 15.50) | 2.61 (0.59, 163.4) | ||
| IL-7 | ||||||
| Median (range) | 10.47 (0.02, 77.63) | 11.71 (0.90, 111.9) | 9.05 (0.17, 33.53) | 11.37 (0.82, 51.89) | ||
| n (%) with value below limit | 3 (1.5%) | 1 (0.5%) | 0.04 | 0 (0.0%) | 0 (0.0%) | 0.24 |
| IL-8 | ||||||
| Median (range) | 5.40 (0.02, 53.55) | 5.63 (0.13, 71.61) | 5.85 (1.03, 54.14) | 5.50 (0.06, 47.08) | ||
| n (%) with value below limit | 1 (0.5%) | 0 (0.0%) | 1 (0.5%) | 1 (0.5%) | ||
| IL-12 p70 | ||||||
| Median (range) | 2.15 (0.03, 798.4) | 3.46 (0.04, 476.6) | 1.50 (0.03, 99.70) | 2.30 (0.03, 302.7) | ||
| n (%) with value below limit | 32 (16.0%) | 32 (16.0%) | 0.19 | 23 (11.5%) | 21 (10.6%) | 0.11 |
| IL-17 | ||||||
| Median (range) | 3.00 (0.07, 302.2) | 3.04 (0.16, 631.6) | 2.98 (0.07, 162.1) | 3.04 (0.17, 762.0) | ||
| n (%) with value below limit | 108 (54.0%) | 137 (68.5%) | 0.92 | 107 (53.5%) | 101 (50.8%) | 0.001 |
| TNFα | ||||||
| Median (range) | 10.92 (0.10, 101.2) | 11.48 (1.37, 120.9) | 15.61 (2.28, 94.94) | 11.08 (1.12, 77.28) | ||
| n (%) with value below limit | 1 (0.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | ||
| IFNγ | ||||||
| Median (range) | 5.47 (0.09, 696.7) | 7.17 (0.04, 293.0) | 4.30 (0.08, 142.2) | 5.43 (0.03, 301.2) | ||
| n (%) with value below limit | 18 (9.0%) | 16 (8.0%) | 0.86 | 17 (8.5%) | 19 (9.5%) | 0.58 |
| GM-CSF | ||||||
| Median (range) | 1.23 (0.05, 367.3) | 1.42 (0.05, 169.1) | 0.86 (0.01, 71.86) | 1.46 (0.01, 110.7) | ||
| n (%) with value below limit | 34 (17.0%) | 52 (26.0%) | 1.00 | 34 (17.0%) | 31 (15.6%) | 0.01 |
| IL-4 | ||||||
| Median (range) | 22.99 (0.01, 1567) | 30.12 (0.01, 1743) | 19.13 (0.01, 1361) | 25.73 (0.01, 1541) | ||
| n (%) with value below limit | 15 (7.5%) | 21 (10.5%) | 0.85 | 14 (7.0%) | 14 (7.0%) | 0.22 |
| IL-5 | ||||||
| Median (range) | 0.49 (0.01, 38.41) | 0.67 (0.02, 30.62) | 0.42 (0.01, 65.74) | 0.59 (0.01, 16.40) | ||
| n (%) with value below limit | 28 (14.0%) | 29 (14.5%) | 0.22 | 20 (10.0%) | 19 (9.5%) | 0.13 |
| IL-10 | ||||||
| Median (range) | 23.63 (0.08, 478.2) | 25.85 (1.54, 651.1) | 28.16 (4.47, 438.9) | 24.69 (0.18, 402.8) | ||
| n (%) with value below limit | 3 (1.5%) | 0 (0.0%) | 0.04 | 0 (0.0%) | 1 (0.5%) | 0.24 |
| IL-13 | ||||||
| Median (range) | 4.60 (0.01, 676.3) | 5.67 (0.01, 601.9) | 2.69 (0.01, 685.5) | 5.89 (0.01, 611.0) | ||
| n (%) with value below limit | 62 (31.0%) | 77 (38.5%) | 0.38 | 54 (27.0%) | 58 (29.1%) | 0.05 |
| CXCL1 | ||||||
| Median (range) | 269.4 (50.48, 2251) | 271.8 (31.09, 3193) | 522.3 (95.70, 8728) | 273.7 (51.75, 2903) | ||
| n (%) with value below limit | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | ||
For the calculation of the medians, values below detectable levels were set equal to the lower limit. DC, drug conservation; GM-CSF, granulocyte macrophage colony-stimulating factor; IFN, interferon; IL, interleukin; TNF, tumor necrosis factor; VS, viral suppression.
a
χ2-test.