Changes of cytokine profile measures during the treatment of rheumatoid arthritis with rituximab biosimilar (Acellbia, BIOCAD) and the original drug (MabThera, F. Hoffmann-La Roche Ltd., Switzerland)

Abstract

The aim of the investigation was to study the changes of cytokine profile parameters in patients with rheumatoid arthritis (RA) 12 and 24 weeks after initiation of therapy with rituximab (RTM) biosimilar at a total dose of 1200 mg, in comparison with the original drug Material and methods. The study included 54 patients with a reliable diagnosis of RA. Depending on the therapy, all patients were divided into two groups: 34 patients received the original RTM (group 1) and 20 patients – biosimilar (group 2) in a total dose of 1200 mg according to the standard scheme. The concentration of 27 cytokines in blood serum was determined by multiplex xMAP technology on the analyzer Bio-Plex Array System (BIO-RAD, USA). Results and discussion. The use of the original drug has been accompanied by reliable and significant reduction (over 30%) by 24 weeks of treatment levels of proinflammatory [interleukin (IL) 1â, IL2, IL6, IL12, IL15, interferon ã (IFN-ã), tumor necrosis factor á (TNF-á)], IL1 receptor antagonist (IL1ra), IL5, IL9, IL10, IL13 cytokines, growth factors (IL7, granulocyte-macrophage colony stimulating factor, fibroblast growth factor) and chemokines (monocyte chemoattractant protein 1 – MCP1). During the treatment with Acellbia a rapid and marked reduction in the concentration of practically the whole range of investigated parameters already 12–24 weeks after the first infusion was achieved. After 24 weeks a decrease in the concentration IL1â, IL1ra, IL2, IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL12, IL13, IL15, IL17, eotaxin, granulocyte colony-stimulating factor, IFN-ã, IFN-ã-induced protein 10, MCP1, macrophage inflammation protein 1â, TNF-á, vascular endothelial growth factor was recorded (p<0.05). Conclusion. Analysis of the effectiveness of two infusions of RTM biosimilar Acellbia («BIOCAD», Russia) 24 weeks after the start of therapy shows its ability to cause a decrease of levels of proinflammatory cytokines, chemokines and growth factors in the blood serum. Changes of the cytokine profile during the therapy with Acellbia are not significantly different from that during the treatment with the original drug.

Keywords

• rituximab biosimilar
• acellbia
• cytokine profile
• rheumatoid arthriti