The role of laboratory biomarkers in monitoring of rituximab biosimilar therapy (Acellbia, “BIOCAD”) in patients with rheumatoid arthritis


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Abstract

Aim: to evaluate the role of laboratory biomarkers in monitoring effectiveness of rituximab (RTM) biosimilar therapy in a total dose of 1200 mg. Materials and methods. 20 patients (pts) with rheumatoid arthritis (RA) (18 woman, mean age 61.5(54-66.5) years, mean disease duration 39.5(20-84) months, mean DAS28 5.6(4.9-6.8)) received two intravenous RTM biosimilar infusions (600 mg №2) in combination with DMARDs and glucocorticoids. Laboratory biomarkers were assessed at baseline and weeks 12 and 24 after the first infusion of RTX. Results. RTM biosimilar induced decreases in DAS28, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) at week 12 and 24, p<0.05. The decrease in the concentration of immunoglobulin (Ig) M rheumatoid factor (RF) was detected at week 12 and 24 and amounted to 79.7% and 87.1% of the initial level, respectively (p<0.05). IgA RF level decreased by 72% and 85% from baseline, respectively, at the 12 and 24 week of RTM therapy in patients with a good effect of the drug (p<0.05). The concentration of antibodies to cyclic citrullinated peptide in the sera did not reduced. 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 (0.0030 (0.0003-0.0270) 109/l). The immunoglobulin level decreased at week 24, but remained normal. RTM biosimilar therapy was accompanied by a rapid and pronounced decrease in the concentration of cytokine profile by 12-24 weeks after the first infusion. Conclusion. RTX biosimilar therapy induced a rapid and significant improvement in ESR, CRP, IgM/IgA RF, anti-MCV, proinflammatory cytokines, chemokines and growth factors levels and CD19+ B-cells depletion in RA pts. IgM RF and/or antibodies to citrullinated proteins seropositivity, increased levels of interleukin-17 after 12 weeks of treatment can be considered as predictors of a good response to RTM biosimilar therapy.

About the authors

A S Avdeeva

V.A. Nasonova Scientific and Research Institute of Rheumatology

Email: 9056249400@mail.ru
с.н.с. лаб. ранних артритов ФГБНУ «НИИР им. В.А. Насоновой» Moscow, Russia

M V Cherkasova

V.A. Nasonova Scientific and Research Institute of Rheumatology

н.с. лаб. иммунологии и молекулярной биологии ревматических заболеваний ФГБНУ «НИИР им. В.А. Насоновой» Moscow, Russia

D A Kusevich

I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)

м.н.с. лаб. остеоартрита, аспирант каф. внутренних профессиональных болезней и ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia

V V Rybakova

I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)

аспирант каф. внутренних профессиональных болезней и ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia

A S Artyuhov

Department of Regenerative Medicine; Institute of Developmental Biology, Russian Academy of Sciences, Laboratory of Cell Proliferation, Pirogov Russian National Research Medical University

м.н.с. отд. регенеративной медицины НИИ трансляционной медицины РНИМУ им. Н.И. Пирогова Moscow, Russia

Eh B Dashinimaev

Department of Regenerative Medicine; Institute of Developmental Biology, Russian Academy of Sciences, Laboratory of Cell Proliferation, Pirogov Russian National Research Medical University

с.н.с. лаб. клеточной биологии ИБР РАН им. Н.К. Кольцова; н.с. отд. регенеративной медицины НИИ трансляционной медицины РНИМУ им. Н.И. Пирогова Moscow, Russia

N V Chichasova

V.A. Nasonova Scientific and Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)

старший преподаватель отд. ординатуры и аспирантуры ФГБНУ «НИИР им. В.А. Насоновой»; проф. каф. ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia

E L Nasonov

V.A. Nasonova Scientific and Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)

акад. РАН, д.м.н., проф., научный руководитель ФГБНУ «НИИР им. В.А. Насоновой»; зав. каф. ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia

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