Table 2

Summary of primary and key secondary PK/PD results (PK analysis set)

Treatment comparison
PK parameter (unit)TreatmentnAdjusted geometric mean ComparisonGeometric mean ratio90% CI of mean ratio*
Primary PK endpoints
 AUC0-inf (day*µg/mL)GP20131247627.44RTX-US vs RTX-EU1.093(0.989 to 1.208)
RTX-US807536.89GP2013 vs RTX-US1.012(0.925 to 1.108)
RTX-EU796896.97GP2013 vs RTX-EU1.106(1.010 to 1.210)
Key secondary PK endpoints
 Cmaxfirst inf. (µg/mL)GP2013120361.53RTX-US vs RTX-EU1.050(0.946 to 1.167)
RTX-US82335.88GP2013 vs RTX-US1.076(0.979 to 1.184)
RTX-EU78319.80GP2013 vs RTX-EU1.131(1.027 to 1.244)
Main PD endpoint (B cell depletion)
 AUEC0-14d (%*day)GP20131101226.53RTX-US vs RTX-EU1.033(1.016 to 1.050)
RTX-US801240.57GP2013 vs RTX-US0.989(0.974 to 1.004)
RTX-EU761201.15GP2013 vs RTX-EU1.021(1.003 to 1.040)
  • AUC0-inf, area under the serum concentration–time curve from study drug infusion to infinity; AUEC, area under the effect curve; PD, pharmacodynamic; PK, pharmacokinetic; RTX,  rituximab.