Table 4.
Summary of PK parameters of vedolizumab
| Day relative to allo-HSCT | Dose level, mg | Parameter | AUC, d × µg/mL | Cmax, µg/mL | Ctrough, µg/mL |
|---|---|---|---|---|---|
| Day −1 | 75 | n | 3 | 3 | NA |
| Mean (SD) | 136.9 (39.8) | 22.6 (6.2) | |||
| CV, % | 29 | 28 | |||
| Geometric mean | 133.1 | 22.1 | |||
| Geometric CV, % | 30 | 26 | |||
| 300 | n | 21 | 21 | ||
| Mean (SD) | 540.8 (142.5) | 92.2 (26.1) | |||
| CV | 26 | 28 | |||
| Geometric mean | 526.1 | 89.0 | |||
| Geometric CV | 23 | 27 | |||
| Day +13 | 75 | n | 3 | 3 | 3 |
| Mean (SD) | 390.7 (234.3) | 31.8 (17.4) | 5.9 (3.0) | ||
| CV | 60 | 55 | 51 | ||
| Geometric mean | 344.1 | 28.9 | 5.34 | ||
| Geometric CV | 69 | 56 | 58 | ||
| 300 | n | 19 | 20 | 21 | |
| Mean (SD) | 1469.5 (612.6) | 132.8 (116.7) | 21.3 (6.1) | ||
| CV | 42 | 88 | 28 | ||
| Geometric mean | 1373.3 | 114.3 | 20.7 | ||
| Geometric CV | 38 | 48 | 26 | ||
| Day +42 | 75 | n | 2 | 3 | 3 |
| Mean (SD) | 1326.5 (748.9) | 40.2 (13.7) | 8.2 (5.2) | ||
| CV | 56 | 34 | 64 | ||
| Geometric mean | 1216.2 | 38.4 | 7.0 | ||
| Geometric CV | 66 | 40 | 80 | ||
| 300 | n | 17 | 19 | 19 | |
| Mean (SD) | 5350.9 (4404.8) | 169.7 (140.6) | 29.1 (13.0) | ||
| CV | 82 | 83 | 45 | ||
| Geometric mean | 4545.7 | 147.2 | 26.5 | ||
| Geometric CV | 55 | 48 | 47 |
Anomalous concentrations are excluded.
HSCT, hematopoietic stem cell transplantation; NA, not applicable.