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. 2016 Nov 17;57(4):459–468. doi: 10.1002/jcph.826

Table 2.

Tocilizumab Exposure in Week 24 (Observed) and at Steady State (Predicted) by Baseline Body Weight Categories

TCZ 162 mg SC QW TCZ 162 mg SC Q2W TCZ 8 mg/kg IV Q4W
Body Weight Observed Model Predicted Observed Model Predicted Observed Model Predicted
Ctrough (μg/mL)
<60 kg

  • 62.1 ± 30.5

  • (59.0: 0–151)

  • n = 105

  • 62.6 ± 22.1

  • (59.8: 17.3–145.2)

  • n = 143

  • 11.70 ± 7.91

  • (11.5: 0–37.4)

  • n = 90

  • 10.2 ± 6.9

  • (10.6: 0.2–34.4)

  • n = 136

  • 15.2 ± 11.4

  • (12.0: 0–50.0)

  • n = 116

  • 13.2 ± 11.4

  • (10.6: 0.1–61.5)

  • n = 146
60 to <100 kg

  • 41.5 ± 24.7

  • (37.6: 0–154)

  • n = 325

  • 42.4 ± 19.0

  • (40.5: 1.3–123.4)

  • n = 420

  • 6.16 ± 6.74

  • (4.90: 0–35.5)

  • n = 238

  • 4.6 ± 5.3

  • (2.6: 0.1–28.3)

  • n = 346

  • 19.8 ± 14.5

  • (17.6: 0–86.3)

  • n = 322

  • 18.8 ± 12.7

  • (16.4: 0.1–68.3)

  • n = 416
≥100 kg

  • 21.6 ± 14.5

  • (17.6: 0.7–61.7)

  • n = 47

  • 23.0 ± 13.5

  • (19.7: 2.2–61.2)

  • n = 58

  • 2.03 ± 2.82

  • (0.288: 0–8.95)

  • n = 19

  • 1.0 ± 1.6

  • (0.2: 0.0–5.8)

  • n = 27

  • 20.8 ± 13.0

  • (18.4: 3.7–52.5)

  • n = 42

  • 31.0 ± 23.5

  • (24.3: 0.2–158.7)

  • n = 67
AUCτ (μg·day/mL)
<60 kg

  • 470.5 ± 157.2

  • (452.6: 129.0–1038.0)

  • n = 143

  • 220.4 ± 113.1

  • (212.0: 34.1–607.5)

  • n = 136

  • 1338.8 ± 461.7

  • (1260.1: 461.4–3199.0)

  • n = 146
60 to <100 kg

  • 323.7 ± 135.7

  • (311.5: 16.3–905.4)

  • n = 420

  • 121.7 ± 88.1

  • (92.6: 8.8–467.5)

  • n = 346

  • 1649.3 ± 493.8

  • (1585.2: 648.8–3498.6)

  • n = 416
≥100 kg

  • 178.8 ± 97.3

  • (154.0: 25.4–447.8)

  • n = 58

  • 48.3 ± 37.1

  • (40.8: 3.0–154.5)

  • n = 27

  • 2282.3 ± 928.1

  • (2146.7: 766.0–7296.5)

  • n = 67
Cmean (μg/mL)
<60 kg

  • 67.2 ± 22.5

  • (64.7: 18.4–148.3)

  • n = 143

  • 15.7 ± 8.1

  • (15.1: 2.4–43.4)

  • n = 136

  • 47.8 ± 16.5

  • (45.0: 16.5–114.3)

  • n = 146
60 to <100 kg

  • 46.2 ± 19.4

  • (44.5: 2.3–129.3)

  • n = 420

  • 8.7 ± 6.3

  • (6.6: 0.6–33.4)

  • n = 346

  • 58.9 ± 17.6

  • (56.6: 24.5–124.9)

  • n = 416
≥100 kg

  • 25.5 ± 13.9

  • (22.0: 3.6–64.0)

  • n = 58

  • 3.5 ± 2.6

  • (2.9: 0.2–11.0)

  • n = 27

  • 81.5 ± 33.1

  • (76.7: 27.4–260.6)

  • n = 67
Cmax (μg/mL)
<60 kg

  • 69.7 ± 22.7

  • (68.0: 19.1–150.1)

  • n = 143

  • 19.0 ± 8.9

  • (17.9: 4.0–48.7)

  • n = 136

  • 129.8 ± 31.1

  • (126.3: 64.1–248.6)

  • n = 146
60 to <100 kg

  • 48.3 ± 19.7

  • (46.4: 2.9–132.6)

  • n = 420

  • 11.2 ± 6.9

  • (9.3: 1.1–37.9)

  • n = 346

  • 152.9 ± 34.7

  • (152.6: 69.2–266.9)

  • n = 416
≥100 kg

  • 26.9 ± 14.2

  • (23.2: 4.4–65.6)

  • n = 58

  • 5.2 ± 3.3

  • (5.0: 0.4–14.5)

  • n = 27

  • 201.8 ± 59.5

  • (200.6: 99.1–492.0)

  • n = 67

Data are mean ± SD (median: min–max). AUCτ, area under the concentration curve within the dosing interval; Cmax, maximum observed concentration; Cmean, average observed concentration; Ctrough, predose trough concentration; IV, intravenous; Q2W, every 2 weeks; Q4W, every 4 weeks; QW, weekly; SC, subcutaneous; TCZ, tocilizumab.