Efficacy of MabThera ® (rituximab) in RA
MabThera® (rituximab) provides lasting improvement in the signs and symptoms of rheumatoid arthritis (RA) after only two infusions per treatment course in tumour necrosis factor (TNF) inhibitor inadequate responder (IR) patients. Importantly, MabThera has been shown to inhibit radiographic progression in this highly pre-treated patient population. The key aim when treating RA is to inhibit progressive joint destruction and, to date, MabThera is the only RA therapy that has demonstrated the ability to do this in the TNF inhibitor IR patient group.
Supporting Evidence for the Efficacy of MabThera® (rituximab) in RA
The first evidence that MabThera® (rituximab) was efficacious in rheumatoid arthritis (RA) came from the pivotal Phase IIa proof-of-concept study, which involved a disease-modifying anti-rheumatic drug (DMARD)-refractory RA patient population (Edwards et al. 2004). MabThera provided lasting improvement after only two infusions per treatment course in these DMARD inadequate responders (IR). These results were exceptionally good considering that the study population had treatment-refractory RA.
Data from the Phase IIb DANCER (Dose-ranging Assessment iNternational Clinical Evaluation of Rituximab in RA) study (Emery et al. 2006) corroborate the efficacy findings from REFLEX (Randomized Evaluation oF Long-term Efficacy of rituXimab in RA) and the Phase IIa proof-of-concept trial.