Case Control Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Pediatr. Mar 9, 2024; 13(1): 89049
Published online Mar 9, 2024. doi: 10.5409/wjcp.v13.i1.89049
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
Processing time: 139 Days and 15.1 Hours
ARTICLE HIGHLIGHTS
Research background

Systemic lupus erythematosus (SLE) is a serious life-threatening disease. Systemic corticosteroids are the still basis of the treatment of SLE.

Research motivation

The side effects of corticosteroids required to change the treatment plans of SLE with biologic implementation.

Research objectives

The place of biologics in the treatment of SLE is not yet determined, despite a lot of clinical observations and studies.

Research methods

The comparison of 12-month course of treatment of pediatric SLE patients with rituximab (RTX) and standard of care treatment without RTX was done.

Research results

RTX worked effective in SLE patients with high activity with improvement of kidney disease.

Research conclusions

RTX might be added in the treatment protocol of the severe pediatric SLE.

Research perspectives

The following randomized controlled trials are required in pediatric SLE.