Table 1.
Biomarker Levels at Baseline (Modified Intention-to-Treat Population)
| Biomarker | Normal Range | Placebo | Tocilizumab |
|---|---|---|---|
| Interleukin-6, ng/mLa | ≤ 0.007 | n = 99 | n = 233 |
| Mean (sd) | 192.2 (368.7) | 201.9 (418.4) | |
| Median (range) | 70.3 (3.1–2,810) | 88.1 (3.1–4,020) | |
| C-reactive protein, mg/L | ≤ 5 | n = 126 | n = 256 |
| Mean (sd) | 177.8 (117.1) | 187.8 (119.8) | |
| Median (range) | 151.9 (1.6–500) | 169.3 (1.1–500) | |
| Ferritin, pmol/La | 27 to ≤ 337 (women) | n = 124 | n = 240 |
| Mean (sd) | 27 to ≤ 674 (men) | 3,792 (7,463) | 3,069 (3,113) |
| Median (range) | 2,168 (96.9–75,300) | 2,250 (3.6–24,045) | |
| d-dimer, μg/mL fibrinogen equivalent unitsa | ≤ 0.5 | n = 66 | n = 131 |
| Mean (sd) | 4.2 (7.6) | 4.6 (8.4) | |
| Median (range) | 1.2 (0.3–46.7) | 1.3 (0.2–58.1) | |
| Lactate dehydrogenase, IU/L | 105–333 | n = 121 | n = 243 |
| Mean (sd) | 469.7 (291.7) | 479.4 (303.5) | |
| Median (range) | 422 (1.3–2,323) | 430 (0.7–3,282) | |
| Leukocytes, 109/La | 4.5–11 | n = 140 | n = 280 |
| Mean (sd) | 9.2 (4.1) | 9.3 (4.5) | |
| Median (range) | 8.5 (2.4–22.4) | 8.3 (2.7–28.2) | |
| Lymphocytes, 109/La | 0.9–2.9 | n = 139 | n = 288 |
| Mean (sd) | 0.96 (0.83) | 0.98 (0.57) | |
| Median (range) | 0.9 (0–8.9) | 0.9 (0–5.4) | |
| Lymphocytes, % | 20–40 | n = 133 | n = 268 |
| Mean (sd) | 13 (10) | 12 (7) | |
| Median (range) | 11 (0–55) | 11 (0–48) | |
| Neutrophils, 109/L | 1.7–7 | n = 139 | n = 291 |
| Mean (sd) | 7.5 (3.9) | 7.6 (4.1) | |
| Median (range) | 7.2 (0.9–23.1) | 6.8 (1.0–24.6) | |
| Neutrophils, % | 40–60 | n = 134 | n = 268 |
| Mean (sd) | 79 (12) | 79 (9) | |
| Median (range) | 82 (24–98) | 81 (44–99) | |
| Neutrophils/lymphocytes, ratioa | 1–3 | n = 132 | n = 265 |
| Mean (sd) | 65.0 (566.5) | 64.8 (683.6) | |
| Median (range) | 7.1 (0.4–6,509) | 7.5 (1.2–10,463) | |
| Monocytes, % | 2–8 | n = 131 | n = 269 |
| Mean (sd) | 6 (4) | 6 (4) | |
| Median (range) | 5 (0–19) | 5 (0–32) | |
| Platelets, 109/L | 150–400 | n = 142 | n = 295 |
| Mean (sd) | 262.0 (117.7) | 265.7 (113.3) | |
| Median (range) | 240 (53–814) | 253 (10.2–825) |
aLog-transformed for all additional analyses.