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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 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 |
