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BCD020 rituximab bioanalog compared to standard treatment in juvenile systemic lupus erythematosus: The data of 12
Elvira Kalashnikova1, Eugenia Isupova1, Ekaterina Gaidar1
1Hospital Pediatry Department, Saint-Petersburg State Pediatric Medical University, Saint-Petersburg 194100, Russia.
Insights
Rituximab (RTX) offers significant benefits for treating severe childhood systemic lupus erythematosus (SLE), effectively reducing disease activity compared to standard care. This biological therapy shows promise in managing this serious autoimmune condition in pediatric patients.
Area of Science:
- Pediatric Rheumatology
- Autoimmune Diseases
- Immunotherapy
Background:
- Systemic lupus erythematosus (SLE) is a serious autoimmune connective tissue disease with limited pediatric treatment guidelines.
- Standard-of-care treatment (SOCT) for pediatric SLE carries risks, including steroid toxicity.
- Rituximab (RTX), a B-lymphocyte-depleting agent, is a potential foundational therapy for pediatric SLE.
Purpose of the Study:
- To compare the efficacy of Rituximab (RTX) versus standard-of-care treatment (SOCT) in pediatric patients with Systemic Lupus Erythematosus (SLE).
Main Methods:
- Retrospective analysis of 79 pediatric SLE cases diagnosed using SLICC criteria (2012-2022).
- Comparison of treatment outcomes between RTX and SOCT groups.
- Assessment of laboratory data, glucocorticosteroid doses, SELENA-SLEDAI disease activity, and organ damage at baseline and one year.
Main Results:
- Patients receiving RTX initially presented with higher disease activity, including central nervous system and kidney involvement.
- After one year, RTX group showed a significantly greater reduction in SELENA-SLEDAI scores (-19 vs. -10 points, P=0.001) compared to SOCT.
- RTX therapy was associated with fewer patients experiencing active lupus nephritis and reduced daily proteinuria; adverse events included infections (3 patients) and bi-cytopenia (1 patient).
Conclusions:
- Rituximab (RTX) is a viable therapeutic option for severe pediatric systemic lupus erythematosus (SLE).
- RTX demonstrates superior ability to reduce disease activity compared to standard-of-care treatment (SOCT).
Background:
Systemic lupus erythematosus (SLE) is the most frequent and serious systemic connective tissue disease. Nowadays there is no clear guidance on its treatment in childhood. There are a lot of negative effects of standard-of-care treatment (SOCT), including steroid toxicity. Rituximab (RTX) is the biological B-lymphocyte-depleting agent suggested as a basic therapy in pediatric SLE.
Aim:
To compare the benefits of RTX above SOCT.
Methods:
The data from case histories of 79 children from the Saint-Petersburg State Pediatric Medical University from 2012 to 2022 years, were analyzed. The diagnosis of SLE was established with SLICC criteria. We compared the outcomes of treatment of SLE in children treated with and without RTX. Laboratory data, doses of glucocorticosteroids, disease activity measured with SELENA-SLEDAI, and organ damage were assessed at the time of initiation of therapy and one year later.
Results:
Patients, treated with RTX initially had a higher degree of disease activity with prevalence of central nervous system and kidney involvement, compared to patients with SOCT. One year later the disease characteristics became similar between groups with a more marked reduction of disease activity (SELENA-SLEDAI activity index) in the children who received RTX [-19 points (17; 23) since baseline] compared to children with SOCT [-10 (5; 15.5) points since baseline, P = 0.001], the number of patients with active lupus nephritis, and daily proteinuria. During RTX therapy, infectious diseases had three patients; one patient developed a bi-cytopenia.
Conclusion:
RTX can be considered as the option in the treatment of severe forms of SLE, due to its ability to arrest disease activity compared to SOCT.
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