29 June 2018 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) has released results from a phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis, the company said.
The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary efficacy endpoint, which compared the response difference measured by 20% or greater improvement defined by the American College of Rheumatology Criteria (ACR20), at week 22.
The primary endpoint of ACR20 had a prespecified equivalence margin of +/- 15%, and the observed upper end of the confidence interval was 15.96%.
ABP 710 is being developed as a biosimilar to infliximab, an anti-tumor necrosis factor alpha monoclonal antibody, which is approved in many regions for the treatment of moderate-to-severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate-to-severe Crohn's disease, moderate-to-severe ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.