IMMUNOLOGICAL EFFECTS OF A RITUXIMAB BIOSIMILAR (ACELBIA, BIOCAD) IN PATIENTS WITH RHEUMATOID ARTHRITIS

Objective: to study changes of acute-phase reactants (erythrocyte sedimentation rate – ESR, C-reactive protein – CRP), autoantibodies (IgM/IgA rheumatoid factors – RF, anti-citrullinated protein antibodies), immunoglobulin classes G, M, and A, and CD19+ B-lymphocytes in patients with rheumatoid arthritis (RA) 12 and 24 weeks after initiation of therapy with a rituximab (RTM) biosimilar at a total dose of 1200 mg.
Subjects and methods. Examinations were made in 20 patients with a reliable diagnosis of RA (including 18 women; median age, 61.5 [54; 66.5] years; disease duration, 39.5 [20; 84] years; DAS28, 5.6 [4.9; 6.8]). All the patients received two intravenous infusions of RTM (Acellbia®) 600 mg at a 2-week interval during therapy with methotrexate, nonsteroidal anti-inflammatory drugs, and glucocorticoids. Clinical and laboratory parameters were analyzed immediately before therapy and then 12 and 24 weeks after the first infusion of the drug.
Results and discussion. DAS28, ESR, and CRP level in respondents significantly decreased 12 and 24 weeks after RTM administration. The serum IgM RF concentration in the respondents was found to be significantly reduced at weeks 12 and 24 and amounted to 79.7 and 87.1% of baseline, respectively. The IgA RF level significantly decreased by 72 and 85% of baseline at weeks 12 and 24 of RTM therapy, respectively, in patients with a good response, and by 59.7 and 67.5% at weeks 12 and 24 in patients with a satisfactory response. The serum concentration of anti-cyclic citrullinated peptide antibodies in the respondents remained high throughout the follow-up. All the patients achieved CD19+ B-cell depletion at week 12 of therapy (absolute levels, 0); there was an increase in the level of CD19+ B-lymphocytes at week 24 (0.0030 [0.0003; 0.0270] 109/l). In both in the good and satisfactory response groups, the mean immunoglobulin levels remained within normal limits.
Conclusion. The analysis of the efficiency of two infusions of the RTM biosimilar at a total dose of 1200 mg following 24 weeks of therapy initiation suggests that the drug is able to cause reductions in disease activity, laboratory signs of inflammatory activity, autoantibody concentrations, and complete B-lymphocyte depletion.

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