AB0366 COMPARISON OF THE EFFECT OF RITUXIMAB (ROCHE) AND RITUXIMAB BIOSIMILAR – BCD-020 (BIOCAD) ON INFLAMMATORY AND IMMUNOLOGICAL BIOMARKERS IN PATIENTS WITH RHEUMATOID ARTHRITIS
Authors: Anastasia Avdeeva, Maria Cherkasova, Alexander Artyuhov, Eh. Dashinimaev, D. Kusevich, Alexander Lila, Evgeny Nasonov
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> 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 <h3>Objectives</h3> 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 <h3>Methods</h3> 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 <b>-</b> 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 <h3>Results</h3> RTX and BCD-020 induced decreases in ESR, levels of CRP, IgMRF, IgARF, anti-MCV at week 12 and 24, p&lt;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&lt;0.05, fig.1. <h3>Conclusion</h3> 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 <h3>Disclosure of Interests</h3> 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