Early Rituximab as an Add-On Therapy in Children With the Initial Episode of Nephrotic Syndrome.

Autor: Liu J; Department of Nephrology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China., Deng F; Department of Nephrology, Children's Hospital of Anhui Medical University, Anhui, China., Wang X; Department of Nephrology and Rheumatology, Wuhan Children's Hospital, Wuhan, China., Liu C; Department of Nephrology and Rheumatology, Children's Hospital affiliated to Zhengzhou University, Zhengzhou, China., Sun S; Department of Nephrology and Rheumatology, Shandong Provincial Hospital, Shandong, China., Zhang R; Department of Nephrology and Rheumatology, Xuzhou Children's Hospital, Xuzhou, China., Zhang A; Department of Nephrology, Children's Hospital of Nanjing Medical University Nanjing, China., Jiang X; Department of Pediatric, The First Affiliated Hospital of Zhongshan University, Guangzhou, China., Yan W; Department of Clinical Epidemiology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China., Dou Y; Department of Clinical Epidemiology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China., Zhang Y; Department of Clinical Epidemiology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China., Xie L; Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; Clinical Research Promotion and Development Center, Shanghai Hospital Development Center, Shanghai, China., Qian B; Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; Clinical Research Promotion and Development Center, Shanghai Hospital Development Center, Shanghai, China., Shen Q; Department of Nephrology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China., Xu H; Department of Nephrology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.
Jazyk: angličtina
Zdroj: Kidney international reports [Kidney Int Rep] 2024 Feb 16; Vol. 9 (5), pp. 1220-1227. Date of Electronic Publication: 2024 Feb 16 (Print Publication: 2024).
DOI: 10.1016/j.ekir.2024.02.1395
Abstrakt: Introduction: The approximately 70% 12-month relapse in children experiencing the initial episode of steroid-sensitive nephrotic syndrome (SSNS) is a significant concern, with over 50% developing frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS). There is a lack of strategies to reduce relapse after the onset. Whether early administration of rituximab, which effectively reduces relapses in FRNS/SDNS, may be a solution has not been evaluated.
Methods: A prospective, multicenter, open-label, single-arm trial was conducted in China, with a 12-month follow-up. Children aged 1 to 18 years with the first episode of nephrotic syndrome (NS) were screened for eligibility. Proteinuria was evaluated daily using dipsticks. A dose of 375 mg/m 2 of rituximab was intravenously infused within 1 week after achieving corticosteroid-induced remission. The main outcome was 12-month relapse-free survival.
Results: Out of the initially 66 children screened, 44 were enrolled and received rituximab, with all but 1 participant completing the 12-month follow-up. The median age at diagnosis was 4.3 years (interquartile range [IQR]: 3.4-5.9), and 33 (77%) of the participants were male. In the rituximab group, the 12-month relapse-free survival was significantly higher compared to historical controls (32 of 43 [74.4%] vs. 10 of 33 [30.3%]; P  < 0.001; hazard ratio [HR], 3.76; 95% confidence interval [CI], 1.80-7.81). The post hoc analysis revealed a higher 24-month relapse-free survival and a lower incidence of FRNS/SDNS at the 12-month follow-up. Treatment with rituximab was well-tolerated.
Conclusion: Our findings support that early administration of rituximab may be associated with a higher 12-month relapse-free survival and a reduced incidence of FRNS/SDNS in children experiencing the initial episode of SSNS.
(© 2024 International Society of Nephrology. Published by Elsevier Inc.)
Databáze: MEDLINE