Background BCD-020 (BIOCAD) is the first Russian rituximab (RTX) biosimilar which was approved for medical use in rheumatoid arthritis (RA) patients in Russia and some CIS countries

Objectives To evaluate the changes in acute phase reactants, autoantibodies, immunoglobulins, cytokine profile and CD19+B lymphocytes in patients (pts) with RA during RTX and RTX biosimilar therapy

Methods The study included 54 RA patients (pts), divided into two groups. The first group included 34 pts with RA (31 women, mean age 49(42-64), mean disease duration 66(36-132) months, mean DAS 28 6.2 (5.5-6.8)) who received two infusions of RTX - 35% at a dose of 500 mg, 65% of the dose of 1000 mg every two weeks in combination with DMARDs and glucocorticoids; 33 pts achieved a good/moderate EULAR response at week 24. The second group - 20 pts with RA (18 woman, mean age 61.5(54-66.5) years, mean disease duration 39.5(20-84) months, mean DAS 28 5.6(4.9-6.8)) who received two intravenous BCD-020 infusions (600mg No 2) in combination with DMARDs and glucocorticoids; 17 pts achieved a good/moderate EULAR response at week 24. Laboratory biomarkers were assessed at baseline and weeks 12 and 24 after the first infusion of RTX. ESR (mm/hr) (Westergren method); serum concentrations of CRP (mg/L), IgM RF (IU/ml) (laser nephelometry); anti-CCP2 (U/ml), IgA RF (U/ml), anti-MCV (U/ml) (ELISA kits); cytokine profile (xMAP technology) were assessed

Results RTX and BCD-020 induced decreases in ESR, levels of CRP, IgMRF, IgARF, anti-MCV at week 12 and 24, p<0.05 (tabl.1). At week 24 – 20% of IgMRF positive pts at baseline (in the first group) and 10% of IgMRF positive pts (in the second group) turned negative. Levels of anti-CCP2 did not reduced. At week 24 – 7% of anti-CCP2 positive pts at baseline (in the first group) and 15% of anti-CCP2 positive pts (in the second group) turned negative. Depletion of CD19+B-cells was achieved at week 12 in all patients (absolute number 0), with an increase in the level of B cells at week 24, tabl.1. The immunoglobulin level decreased at week 24, but remained normal. In the first group RTX induced reduction in proinflammatory (IL-1b, IL-2, IL-6, IL-12, IL-15, IFN-γ, TNF-α), anti-inflammatory cytokines (IL-1Ra, IL-5, IL-9, IL-10, IL-13), growth factors (IL-7, GM-CSF, FGF-basic) and chemokines (MC-1) at week 24 (fig.1). In the second group BCD-020 induced reduction in IL-1b, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17, Eotaxin, G-CSF, IFN-γ, IP-10, MC-1, MIP-1β, TNF-α, VEGF at week 24 p<0.05, fig.1.

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Figure 1

Conclusion RTM biosimilar (BCD-020) has a similar effect on inflammatory and immunological biomarkers to the original RTM. BCD-020 therapy induced a rapid and significant improvement in ESR, levels of CRP, IgM/IgARF, anti-MCV, proinflammatory, anti-inflammatory cytokines, growth factors, chemokines levels and CD19+B cells depletion in RA pts

Disclosure of Interests Anastasia Avdeeva: None declared, Maria Cherkasova: None declared, Alexander Artyuhov: None declared, Eh. Dashinimaev: None declared, D. Kusevich: None declared, Alexander Lila Speakers bureau: Pfizer, Inc., MSD, Novartis, AbbVie Inc., Celgen Corporation, Biocad, Janssen, UCB, Inc., Evgeny Nasonov: None declared