Table 2

PK endpoints (PK population)

ParameterCT-P10
(N=96)
RTX
(N=45)
Primary endpoints*
 AUC0–last (day×µg/mL)7838.68021.9
  Ratio of geometric means (%)
90% CI of ratio (%)
97.7
89.2 to 107.0
 Cmax (µg/mL)465.9477.5
  Ratio of geometric means (%)
90% CI of ratio (%)
97.6
92.0 to 103.5
Secondary endpoints†
 Cmax, 1 (µg/mL)391.2±127.2396.2±87.3
 Ctrough (µg/mL)85.1±75.580.3±23.6
 Vd (L)5.3±1.45.2±1.3
 CL (L/day)0.3±0.10.3±0.1
 T1/2 (day)14.9±3.714.5±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.