Phase 3 randomised double-blind multicentre study with open-label extension period (100 weeks) in RA patients from centres in the Czech Republic and Poland who continued after 52 weeks of treatment
ACR20 at Week 24 and the evaluation of long-term efficacy, safety and immunogenicity when continuing Benepali™ compared vs. switching from oETN to Benepali™.
Numbers subsequent to initial randomisation are the numbers who completed the intended study timepoints (i.e. 24 weeks, 52 weeks, and 100 weeks). Efficacy analyses were undertaken in patients receiving ≥1 dose of study drug, therefore patient numbers may be higher than shown in the study design.
Benepali™ controls disease activity as well as oETN2,3
Adapted from: Emery P, et al. 2017.
Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept.