Rituximab GP2013 Rituxan (US) Randomised, Adult 90% CI for the ratio The rate of binding [3] (Sandoz) and double-blind, rheumatoid of treatment ADAs was 16.5% in MabThera two dose, arthritis means for the GP2013 trial (EU) 1000mg three-arm, patients compared with parallel group (n=312) from time zero 15.1% in originator study (1:1:2) extrapolated to rituximab treated infinite time patients. Five (AUC0-∞) and patients in the maximal plasma GP2013 arm and concentration one patient in the (Cmax) were within originator rituximab the pre-specified arm exhibited limits of 80-125% neutralising ADAs. for the No differences in comparisons of immunogenicity GP2013 with profiles between the Rituxan and treatments were GP2013 with noted. MabThera, as well as for Rituxan vs MabThera. from time zero to the last quantifiable concentration was not assessed. 90% CI for the ratio of treatment means for peripheral CD19 positive B-cell count relative to baseline up to the second infusion on Day 15 were within the pre-specified limits of 80-125% for the comparisons of GP2013 with Rituxan and GP2013 with MabThera, as well as for Rituxan vs MabThera.
Rituximab GP2013 (Sandoz) Rituxan (US) and MabThera (EU) 1000mg Randomised, double-blind, two dose, three-arm, parallel group study (1:1:2) Adult rheumatoid arthritis patients (n=312) 90% CI for the ratio of treatment means for from time zero extrapolated to infinite time (AUC0-∞) and maximal plasma concentration (Cmax) were within the pre-specified limits of 80-125% for the comparisons of GP2013 with Rituxan and GP2013 with MabThera, as well as for Rituxan vs MabThera. from time zero to the last quantifiable concentration was not assessed. 90% CI for the ratio of treatment means for peripheral CD19 positive B-cell count relative to baseline up to the second infusion on Day 15 were within the pre-specified limits of 80-125% for the comparisons of GP2013 with Rituxan and GP2013 with MabThera, as well as for Rituxan vs MabThera. The rate of binding ADAs was 16.5% in the GP2013 compared with 15.1% in originator rituximab treated patients. Five patients in the GP2013 arm and one patient in the originator rituximab arm exhibited neutralising ADAs. No differences in immunogenicity profiles between the treatments were noted. [3] trial
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