Table 3.
Vedolizumab pharmacokinetic parameters after multiple-dose intravenous administration in patients with ulcerative colitis [Table reproduced from Parikh et al. [27] ((c) Wolters Kluwer Health, Inc.), with permission of Wolters Kluwer Health, Inc.]
| Parameter | Vedolizumab dosea | ||
|---|---|---|---|
| 2.0 mg/kg (n = 10b) | 6.0 mg/kg (n = 14b) | 10.0 mg/kg (n = 11b) | |
| C max, day 1 (µg/mL) | 54.0 (8.9) | 154.3 (41.5) | 279.0 (167.9) |
| C max, day 85 (µg/mL) | 60.4 (12.5) | 191.9 (42.6) | 291.9 (95.0) |
| AUCday 0–14 (µg·day/mL) | 375 (59) | 1058 (270) | 1765 (822) |
| AUCday 85–99 (µg·day/mL) | 473 (92) | 1532 (227) | 2608 (795) |
| t ½ (day) | 15.1 (2.0) | 22.0 (6.7) | 20.6 (7.2) |
ADA anti-drug antibody, AUC area under the serum concentration–time curve, C max maximum observed serum concentration, t ½ β terminal elimination half-life, %CV percent coefficient of variation
aValues are presented as arithmetic mean (%CV)
bNumber of participants included in the pharmacokinetic analysis. Patients who were persistently ADA positive (≥2 positive samples or 1 positive sample with a titer of ≥25) were excluded from the analysis