Copyright
©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
BCD020 rituximab bioanalog compared to standard treatment in juvenile systemic lupus erythematosus: The data of 12 months case-control study
Elvira Kalashnikova, Eugenia Isupova, Ekaterina Gaidar, Lyubov Sorokina, Maria Kaneva, Vera Masalova, Margarita Dubko, Tatiana Kornishina, Natalia Lubimova, Ekaterina Kuchinskaya, Irina Chikova, Rinat Raupov, Olga Kalashnikova, Mikhail Kostik
Elvira Kalashnikova, Eugenia Isupova, Ekaterina Gaidar, Lyubov Sorokina, Maria Kaneva, Vera Masalova, Margarita Dubko, Tatiana Kornishina, Irina Chikova, Rinat Raupov, Olga Kalashnikova, Mikhail Kostik, Hospital Pediatry Department, Saint-Petersburg State Pediatric Medical University, Saint-Petersburg 194100, Russia
Natalia Lubimova, Ekaterina Kuchinskaya, Mikhail Kostik, Research Laboratory of Autoimmune and Autoinflammatory Diseases, Almazov National Medical Research Centre, Saint Petersburg 197341, Russia
Rinat Raupov, Department of Rheumatology, Turner National Medical Research Center for Сhildren’s Orthopedics and Trauma Surgery, Saint-Petetrsburg 197136, Russia
Author contributions: Kostik M and Kalashnikova E contributed to conceptualization writing—original draft preparation, writing—review and editing; Kostik M and Chikova I contributed to methodology; Kalashnikova O contributed to software; Isupova E, Gaidar E, and Sorokina L contributed to validation; Raupov R contributed to formal analysis; Kaneva M, Masalova V, Dubko M, and Kornishina T contributed to investigation; Isupova E and Gaidar E contributed to resources; Kalashnikova O and Chikova I contributed to data curation; Kostik M, Lubimova NA, and Kuchinskaya E contributed to funding; Kaneva M contributed to visualization; Kostik M contributed to supervision, project administration; All authors have read and approve the final manuscript.
Supported by the Ministry of Science and Higher Education of the Russian Federation, No. 075-15-2022-301; and the Russian Science Foundation, No. 22-45-08004.
Institutional review board statement: Written consent was obtained according to the declaration of Helsinki. The Ethics Committee of Saint Petersburg State Pediatric Medical University (protocol number 1/3 from 11.01.2021) approved this retrospective study's protocol.
Informed consent statement: All patients or patients' representatives (for patients under the age of 15) gave their consent in their case report forms authorizing the anonymous use of their medical information. All patients were appropriately anonymized.
Conflict-of-interest statement: All the authors declare that they have no conflict of interest.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Mikhail Kostik, MD, PhD, Professor, Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Lytovskaya 2, Saint-Petersburg 194100, Russia. kost-mikhail@yandex.ru
Received: October 19, 2023
Peer-review started: October 19, 2023
First decision: December 7, 2023
Revised: February 2, 2024
Accepted: January 30, 2024
Article in press: January 30, 2024
Published online: March 9, 2024
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.
Core Tip: Rituximab (RTX), known as an anti-B-cells agent, is actively discussed as one of the main drugs for severe systemic lupus erythematosus. Various studies have been conducted to evaluate its effectiveness, but their results are ambiguous. We show the benefits of RTX above the standard-of-care treatment in children.
