Phase III study of ABP 710 confirms non-inferiority to Remicade in rheumatoid arthritis.- Amgen.

Amgen announced results from a Phase III study evaluating the efficacy and safety of ABP 710 (infliximab biosimilar) compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis. 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 percent or greater improvement defined by the American College of Rheumatology (ACR) Criteria, ACR20, at week 22.

Key secondary endpoints included ACR50, ACR70 and Disease Activity Score 28-joint count C reactive protein (DAS28-CRP). The primary endpoint of ACR20 had a prespecified equivalence margin of +/- 15 percent, and the observed upper end of the confidence interval was 15.96 percent. ACR50 and ACR70 trended in the same direction as ACR20. Notably, the DAS28-CRP difference in mean change from baseline was close to zero (-0.01 [-0.20, 0.17]). Overall, the safety profile and immunogenicity were comparable between ABP 710 and infliximab.

Comment: ABP 710 is being developed as a biosimilar to infliximab, an anti-tumor necrosis factor alpha (anti-TNF) 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.