Table 1.
Vedolizumab pharmacokinetic parameters after a single intravenous infusion (0.2–10.0 mg/kg) in healthy volunteers [reproduced from Rosario et al. [25] (© Springer International Publishing Switzerland 2016), with permission of Springer]
| Parameter | Vedolizumab dosea | ||||
|---|---|---|---|---|---|
| 0.2 mg/kg (n = 4b) | 0.5 mg/kg (n = 4b) | 2.0 mg/kg (n = 7b) | 6.0 mg/kg (n = 6b) | 10.0 mg/kg (n = 7b) | |
| C max (µg/mL) | 5.62 (11.1) | 10.4 (19.7) | 58.4 (19.6) | 150 (12.6) | 243 (9.07) |
| AUC0−tlast (µg·day/mL) | 31.3 (15.8) | 119 (37.9) | 955 (15.2) | 3020 (24.2) | 4840 (12.8) |
| AUC0−∞ (µg·day/mL) | 39.1 (14.7) | 127 (36.5) | 969 (14.9) | 3030 (24.2) | 4850 (13.0) |
| V z (L) | 4.02 (3.76) | 4.89 (12.6) | 3.28 (19.9) | 2.92 (21.6) | 2.73 (35.2) |
| CL (L/day) | 0.412 (10.1) | 0.297 (34.3) | 0.164 (10.7) | 0.136 (22.0) | 0.139 (16.9) |
| t ½ (day) | 6.79 (0.736) | 11.7 (2.83) | 14.1 (2.67) | 15.1 (3.15) | 14.8 (7.38) |
ADA anti-drug antibody, AUC 0−∞ area under the serum concentration–time curve from time zero to infinity, AUC 0−tlast area under the serum concentration–time curve from time zero to time of the last quantifiable concentration, CL total clearance, C max maximum observed serum concentration, t ½ β terminal elimination half-life, V z volume of distribution during the terminal phase, %CV percent coefficient of variation
aValues are presented as geometric mean (%CV) for all parameters except t ½, which is presented as arithmetic mean (%CV)
bNumber of participants included in the pharmacokinetic analysis. Participants who were persistently positive for ADAs (≥2 positive samples or 1 positive sample with a titer of ≥25) were excluded from the analysis