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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Outcomes of a 12-month course of early and late rituximab BCD020 biosimilar administration in juvenile systemic lupus erythematosus: A retrospective study
Elvira Kalashnikova, Eugenia Isupova, Ekaterina Gaidar, Natalia Lubimova, Lyubov Sorokina, Irina Chikova, Maria Kaneva, Rinat Raupov, Olga Kalashnikova, Damir Aliev, Inna Gaydukova, Mikhail Kostik
Elvira Kalashnikova, Eugenia Isupova, Ekaterina Gaidar, Lyubov Sorokina, Irina Chikova, Maria Kaneva, Olga Kalashnikova, Mikhail Kostik, Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Sankt-Peterburg, Russia
Natalia Lubimova, Mikhail Kostik, Research Laboratory of Autoimmune and Autoinflammatory Diseases, World-Class Research Centre for Personalized Medicine, Almazov National Medical Research Centre, Saint Petersburg 197341, Sankt-Peterburg, Russia
Rinat Raupov, Pediatric Rheumatology, H. Turner National Medical Research Center for Children’s Orthopedics and Trauma Surgery, Saint Petersburg 196603, Sankt-Peterburg, Russia
Damir Aliev, Inna Gaydukova, Department of Internal Medicine, Rheumatology, Examination of Temporary Disability Examination and Quality of Medical Care named after E.E. Eichwald, I.I. Mechnikov North-Western State Medical University, Saint Petersburg 191015, Sankt-Peterburg, Russia
Damir Aliev, Inna Gaydukova, Department of Rheumatology, Clinical Rheumatological Hospital #25, Saint Petersburg 190068, Sankt-Peterburg, Russia
Author contributions: Kostik MM, Kalashnikova EM, and Kalashnikova LS contributed to conceptualization of the study, and writing, review and editing of the manuscript; Kostik MM and Chikova IA contributed to the methodology; Aliev DB and Gaydukova IZ contributed software and resources, and contributed to the data curation; Kalashnikova OV, Isupova EA, Gaidar EV, and Kaneva MA contributed to the data validation; Lubimova NA and Raupov RK contributed to the formal data analysis; Sorokina LS contributed to the overall investigation and the data visualization; Kostik MM contributed to writing in original draft preparation of the manuscript, and provided funding, supervision, and project administration; All authors have read and agreed to the published version of the manuscript.
Supported by Ministry of Science and Higher Education of the Russian Federation, No. 075-15-2022-301; and the Russian Science Foundation Grant, No. 22-45-08004.
Institutional review board statement: The protocol of the study was approved by the local Ethical Committee of Saint Petersburg State Pediatric Medical University (# 1/3 from 11.01.2021).
Informed consent statement: Informed consent was obtained from all subjects involved in the study. 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 authors declare no conflicts 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.
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, Sankt-Peterburg, Russia.
kost-mikhail@yandex.ru
Received: June 25, 2024
Revised: August 23, 2024
Accepted: September 5, 2024
Published online: December 25, 2024
Processing time: 134 Days and 21.6 Hours
BACKGROUND
Juvenile systemic lupus erythematosus (SLE) is a severe, life-threatening disease. However, the role of rituximab in managing juvenile SLE remains undefined, although early biological intervention may improve disease outcomes.
AIM
To assess the differences in the outcomes of different types of rituximab administration (early and late).
METHODS
In this retrospective cohort study, the information of 36 children with SLE with early (less than 6 months from onset) rituximab administration (ERA), and late (more than 1 year) rituximab administration (LRA) was analyzed. We compared initial disease characteristics at onset, at baseline (start of rituximab), and at the end of the study (EOS) at 12 months, as well as outcomes and treatment characteristics.
RESULTS
The main differences at baseline were a higher daily median dose of corticosteroids, increased MAS frequency, and a higher Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in the ERA group. No differences in the main SLE outcomes between groups at the EOS were observed. The part of lupus nephritis patients who achieved remission changed from 44% to 31% in ERA and 32% to 11% in the LRA group. Patients with ERA had a shorter time to achieve low daily corticosteroid dose (≤ 0.2 mg/kg) at 1.2 (0.9; 1.4) years compared to 2.8 (2.3; 4.0) years (P = 0.000001) and higher probability to achieve this low dose [hazard ratio (HR) = 57.8 (95% confidence interval (CI): 7.2-463.2), P = 0.00001 and remission (SLEDAI = 0); HR = 37.6 (95%CI: 4.45-333.3), P = 0.00001]. No differences in adverse events, including severe adverse events, were observed.
CONCLUSION
ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity, except for lupus nephritis. Further investigations are required.
Core Tip: Systemic lupus erythematosus in children is a severe life-threatening disease that requires systemic immune-suppressive therapy. Early biologic treatment in children with systemic lupus erythematosus can provide faster remission with a better corticosteroid-sparing effect.
