OUTCOMES OF TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS USING THE BIOSIMILAR RITUXIMAB BCD020 COMPARED WITH THE STANDARD NON-BIOLOGIC THERAPY. A RETROSPECTIVE COHORT STUDY

Abstract

Systemic lupus erythematosus (SLE) is an immunopathological disease characterized by various systemic malfunction and a prognosis for unfavorable outcomes. In the current standards of treatment for SLE the biological therapy is not included in the first line of therapy. The data from previous studies do not allow drawing a clear conclusion about the benefits of using biological therapy. The purpose of this research was to study the outcomes of SLE therapy using the rituximab biosimilar BCD020 compared with the standard non-biological therapy. Materials and methods used: a single-center cohort retrospective study of 79 medical records of children aged 0 to 18 y/o suffering from SLE were analyzed: 19 received rituximab as part of multicomponent therapy in the first 6 months from the onset of the disease, the remaining 60 received standard non-biological therapy. Damage to organs and systems, laboratory data, doses of corticosteroid therapy and disease activity were assessed using the SELENA-SLEDAI tool at the time of initiation of therapy and one year after. Results: higher degree of disease activity involving the central nervous system and kidneys was noted in the group of children receiving rituximab therapy. No statistically significant difference between the data of the two groups, including disease activity, was noted in 12 months after the start of the therapy. There was a statistically significantly more pronounced decrease in the SLEDAI activity index after a year in the group of children who received rituximab (p=0.001) compared to children who did not receive it. During rituximab therapy, infectious complications were noted in 3 cases, including the development of meningitis; and a single patient had developed with bicytopenia. Conclusion: rituximab was used in children with higher disease activity, with involvement of organs and systems whose damage leads to an unfavorable prognosis (CNS and renal damage). Rituximab can be considered as an option in the treatment of severe variants of SLE with a poor prognosis due to its ability to more intensively arrest disease activity compared to standard non-biological therapy.