Results from a pooled analysis of three phase 3 trials in rheumatoid arthritis (RA) showed similar efficacy and safety between anti-tumor necrosis factor (TNF) biosimilars, including the SB4 etanercept biosimilar, the SB2 infliximab biosimilar, and the SB5 adalimumab biosimilar, and their reference products. The data were presented at the European League Against Rheumatism (EULAR) Congress held in Amsterdam, June 13 to 16, 2018.
Three separate phase 3 randomized double-blind studies compared the efficacy and safety of SB4 etanercept biosimilar with etanercept, the SB2 infliximab biosimilar with infliximab, and the SB5 adalimumab biosimilar with adalimumab. Researchers assessed the effects of antidrug antibodies on efficacy and tolerability, as well as radiographic progression by disease activity state. All participants had been diagnosed with moderate to severe RA, and the primary end point for each of the studies was the rate of 20% improvement in American College of Rheumatology response.
Pooled immunogenicity data from 1710 patients with RA showed that the incidence of antidrug antibodies was similar for the biosimilars and their reference products. Researchers also evaluated the efficacy of injection site reactions/infusion related reactions in relation to the presence of antidrug antibodies.
They found that the development of antidrug antibodies is associated with reduced clinical efficacy and increased incidence of injection site reactions/infusion related reactions in patients with RA.
The investigators also collected and grouped radiographic data (n=1263) based on patient’s disease activity state at 24 or 30 weeks. They measured radiographic progression using the modified Total Sharp Score at baseline and at 52 or 54 weeks.
Results showed that radiographic progression was minimal and comparable across all treatment groups. Furthermore, participants in the pooled biosimilar group had a lower mean change in mTSS compared with the pooled reference group.
Samsung Bioepis and Biogen announce pooled analysis results of anti-TNF biosimilars Benepali (etanercept) Flixabi (infliximab), and Imraldi (adalimumab) at EULAR 2018 [press release]. Cambridge, Massachusetts: Biogen. http://investors.biogen.com/news-releases/news-release-details/samsung-bioepis-and-biogen-announce-pooled-analysis-results-anti. Published June 13, 2018. Accessed June 22, 2018.