This article is more than 5 years old. Information may no longer be current.
CHS-0214 Biosimilar Shows Equivalence in Efficacy to Etanercept
Click Here to Manage Email Alerts
LONDON — A biosimilar to etanercept shows equivalence in efficacy at the primary endpoint and other measures, according to data presented at the EULAR Annual Congress.
“Results demonstrate the equivalence of CHS-0214 to etanercept with respect to efficacy as measured by the primary endpoint. Secondary endpoints, such as ACR50, ACR70, DAS28-CRP, etc, confirm the equivalence of [CHS-]0214 to etanercept. [CHS-]0214 was well tolerated with no clinically meaningful differences to etanercept with regard to safety or immunogenicity,” said James R. O’Dell, MD, William Bruce distinguished professor and vice chair of internal medicine and chief of the division of rheumatology at the University of Nebraska Medical Center.
James R. O'Dell
In the phase 3, randomized, double blind, multicenter study conducted in 13 countries, O’Dell and researchers of the RAPSODY study group compared the efficacy, safety and immunogenicity of CHS-0214 (Coherus BioSciences) to etanercept (Enbrel, Amgen). In the study, CHS-0214 was compared with etanercept for 24 weeks in patients who had moderate to severe rheumatoid arthritis and inadequate response to methotrexate treatment.
Overall, 644 patients were randomly assigned 50 mg CHS-0214 or etanercept subcutaneously weekly for 24 weeks. The completion rate in the trial was 95%. Primary endpoint was the ACR20 response rate at week 24. To establish CHS-0214’s equivalence to etanercept, researchers set the 95% CI of the treatment difference between groups as –15% to 15%. Secondary efficacy endpoints in the study were ACR50, ACR70 and change in DAS28-CRP, as well as safety and immunogenicity data.
Researchers evaluated the efficacy of the 512 patients who had uninterrupted therapy at 24 weeks. They found an ACR20 response rate was 91% for patients who received CHS-0214 and 90.6% for patients who received etanercept. The 95% CI was –4.55 to 5.37. Response rates at 24 weeks were 67.6% for ACR50 and 38.3% for ACR70 in the CHS-0214 group compared with 63.7% and 37.9%, respectively, in the etanercept group. Mean DAS28-CRP scores were 5.45 and 5.42 at baseline, which decreased to 2.67 and 2.73 at 24 weeks, in the CHS-0214 and etanercept groups, respectively.
O’Dell said adverse events were similar between patient groups, with more injection site reactions in the etanercept patients. There were few serious adverse events — three patients in CHS-0214 group and one patient in the etanercept group.
At the end of 24 weeks, patients who achieved success of ACR20 were given the opportunity to continue the biosimilar or, if they were on etanercept, be switched to CHS-0214. O’Dell said analysis of this part of the study is currently ongoing. – by Kristine Houck, MA, ELS
Reference:
O’Dell JR, et al. Abstract #OP0226. Presented at: EULAR Annual Congress; June 8-11, 2016; London.
Disclosure: O’Dell reports no relevant financial disclosures. One researcher reports employment with Daiichi Sankyo, and two others report employment with Coherus BioSciences.