Summary of primary and key secondary PK/PD results (PK analysis set)
| Treatment comparison | ||||||
| PK parameter (unit) | Treatment | n | Adjusted geometric mean | Comparison | Geometric mean ratio | 90% CI of mean ratio* |
| Primary PK endpoints | ||||||
| AUC0-inf (day*µg/mL) | GP2013 | 124 | 7627.44 | RTX-US vs RTX-EU | 1.093 | (0.989 to 1.208) |
| RTX-US | 80 | 7536.89 | GP2013 vs RTX-US | 1.012 | (0.925 to 1.108) | |
| RTX-EU | 79 | 6896.97 | GP2013 vs RTX-EU | 1.106 | (1.010 to 1.210) | |
| Key secondary PK endpoints | ||||||
| Cmaxfirst inf. (µg/mL) | GP2013 | 120 | 361.53 | RTX-US vs RTX-EU | 1.050 | (0.946 to 1.167) |
| RTX-US | 82 | 335.88 | GP2013 vs RTX-US | 1.076 | (0.979 to 1.184) | |
| RTX-EU | 78 | 319.80 | GP2013 vs RTX-EU | 1.131 | (1.027 to 1.244) | |
| Main PD endpoint (B cell depletion) | ||||||
| AUEC0-14d (%*day) | GP2013 | 110 | 1226.53 | RTX-US vs RTX-EU | 1.033 | (1.016 to 1.050) |
| RTX-US | 80 | 1240.57 | GP2013 vs RTX-US | 0.989 | (0.974 to 1.004) | |
| RTX-EU | 76 | 1201.15 | GP2013 vs RTX-EU | 1.021 | (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.