Biosimilar etanercept: Extension study data
Data from 232 evaluable patients in the open-label extension of a double-blind, European Phase III trial in 596 patients with moderate to severe RA despite methotrexate therapy showed that once-weekly 50 mg subcutaneous Benepali for 100 weeks led to an ACR20 response rate at week 100 of 77.9% vs. 79.1% for patients who switched from Enbrel etanercept to Benepali at week 52. Additionally, Benepali for 100 weeks led to an ACR50 response rate of 59.8% and an ACR70 response rate of 42.6% vs. 60.9% and 41.7%, respectively, for patients who switched from Enbrel to Benepali at week 52. Data were presented at the European League Against Rheumatism meeting in London. Previously reported data showed that Benepali met the primary endpoint of equivalence to Enbrel as measured by ACR20 response rates (see BioCentury, June 15, 2015). ...