Table 2.
PK endpoints (PK population)
| Parameter | CT-P10 (N=96) |
RTX (N=45) |
|---|---|---|
| Primary endpoints* | ||
| AUC0–last (day×µg/mL) | 7838.6 | 8021.9 |
| Ratio of geometric means (%) 90% CI of ratio (%) |
97.7 89.2 to 107.0 |
|
| Cmax (µg/mL) | 465.9 | 477.5 |
| Ratio of geometric means (%) 90% CI of ratio (%) |
97.6 92.0 to 103.5 |
|
| Secondary endpoints† | ||
| Cmax, 1 (µg/mL) | 391.2±127.2 | 396.2±87.3 |
| Ctrough (µg/mL) | 85.1±75.5 | 80.3±23.6 |
| Vd (L) | 5.3±1.4 | 5.2±1.3 |
| CL (L/day) | 0.3±0.1 | 0.3±0.1 |
| T1/2 (day) | 14.9±3.7 | 14.5±3.1 |
| Tmax (hour), median (minimum, maximum) | 3.9 (2.1, 24.0‡) | 3.8 (2.3, 5.3) |
*Values for primary endpoints are the geometric mean.
†Values for secondary endpoints are mean±SD except where indicated otherwise.
‡Only one patient in the CT-P10 group reported an extremely high Tmax (on day 1 of week 0 (ie, at 24 hours)).
AUC0–last, area under the serum concentration–time curve from time zero to last quantifiable concentration; CL, total body clearance over both infusions; Cmax, maximum serum concentration (after second infusion); Cmax, 1, maximum serum concentration after first infusion; Ctrough, trough serum concentration before second infusion; PK, pharmacokinetic; T1/2, terminal elimination half-life after second infusion; Tmax, time to Cmax after both first and second infusions; RTX, rituximab; Vd, volume of distribution.