Etanercept and its biosimilar in the treatment of rheumatoid arthritis: efficacy and safety

N.V. Chichasova^1,2, A.M. Lila^1,2

¹Research Institute of Rheumatology named after V.A. Nasonova, Moscow

²Russian Medical Academy of Continuous Professional Education, Moscow

Nowadays, the main goal of rheumatoid arthritis treatment is to achieve remission, whereas the alternative goal is to achieve low disease activity for six months in every patient. The article presents data on the efficacy and safety of the original drug — etanercept — and its biosimilar Erelzi^®, registered in the Russian Federation. The data on the immunogenicity of genetically engineered biological drugs (GEBD) with an emphasis on the tumor necrosis factor-α (TNF-α) inhibitors are presented. The article indicates the benefits of etanercept over other TNF-α inhibitors associated with its low immunogenicity. Predictors of an increase in the odds ratio for achieving remission with etanercept treatment and the possibility of maintaining remission with a halving of etanercept dose were presented. As for etanercept biosimilar, data on the comparability of pharmacokinetics with the original drug were presented, as well as the results of a multicenter randomized double-blind 48-week study that showed comparability of efficacy and safety compared with the original etanercept. The data on the preservation of treatment efficacy and safety when switching from the original etanercept to this biosimilar were also presented. The introduction of GEBD biosimilars into clinical practice makes it possible to reduce the treatment cost (covering more patients) and increase the availability of optimal therapy for patients with rheumatic diseases. 

Keywords: etanercept, efficacy, safety, immunogenicity, biosimilar, rheumatoid arthritis.

For citation: Chichasova N.V., Lila A.M. Etanercept and its biosimilar in the treatment of rheumatoid arthritis: efficacy and safety. RMJ. 2021;7:44–49.