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Rituximab-induced long-term remission in childhood-onset, uncomplicated, frequently relapsing or steroid-dependent nephrotic syndrome: a randomized, placebo-controlled trial and a follow-up study.

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Název: Rituximab-induced long-term remission in childhood-onset, uncomplicated, frequently relapsing or steroid-dependent nephrotic syndrome: a randomized, placebo-controlled trial and a follow-up study.
Autoři: Iijima, Kazumoto, Sako, Mayumi, Horinouchi, Tomoko, Sakai, Tomoyuki, Yamamura, Tomohiko, Hamada, Riku, Ohtsuka, Yasufumi, Tanaka, Seiji, Kamei, Koichi, Tanaka, Ryojiro, Kano, Yuji, Kubota, Takuo, Shima, Yuko, Morohashi, Tamaki, Inaba, Aya, Fujinaga, Shuichiro, Oka, Masafumi, Kaito, Hiroshi, Konishi, Akihide, Nagano, China
Zdroj: Scientific Reports; 10/10/2025, Vol. 15 Issue 1, p1-14, 14p
Témata: RITUXIMAB, NEPHROTIC syndrome, CLINICAL trials, JUVENILE diseases, DISEASE remission, B cells
Abstrakt: Rituximab maintains remission of complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS) by depleting peripheral B cells, but most patients eventually experience relapses after B cell recovery. We performed a multicenter, double-blind, randomized, placebo-controlled trial to assess rituximab's efficacy and safety for childhood-onset uncomplicated FRNS/SDNS (without prior treatment with glucocorticoid-sparing immunosuppressive agents) with a follow-up study to assess rituximab's long-term effect after B cell recovery. Patients were randomly assigned to receive either rituximab (375 mg/m2, maximum 500 mg, once weekly for 2 weeks) or placebo. The primary endpoint was the relapse-free period. Of 43 randomized patients, 40 received the intervention (18 rituximab, 22 placebo). The relapse-free period during the 1-year trial was significantly longer in the rituximab vs. placebo groups (median: 285 vs. 81 days; p < 0.001). Infusion reactions were more frequent in the rituximab group (p < 0.001), with no difference in adverse events incidence between the groups. Interestingly, the follow-up study demonstrated markedly higher 3-year cumulative relapse-free survival probability without further treatments in the rituximab vs. placebo groups (38% vs. 9%). A mini-systematic review with meta-analyses supported the findings. Rituximab is effective and well-tolerated, potentially leading to long-term remission with substantially high rates after B cell recovery for childhood-onset uncomplicated FRNS/SDNS. Trial registration JSKDC10, Clinical Trials Registry ID: jRCT1091220380; JSKDC10 follow-up study, Clinical Trials Registry ID: jRCT1050230024 [ABSTRACT FROM AUTHOR]
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Databáze: Complementary Index
Popis
Abstrakt:Rituximab maintains remission of complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS) by depleting peripheral B cells, but most patients eventually experience relapses after B cell recovery. We performed a multicenter, double-blind, randomized, placebo-controlled trial to assess rituximab's efficacy and safety for childhood-onset uncomplicated FRNS/SDNS (without prior treatment with glucocorticoid-sparing immunosuppressive agents) with a follow-up study to assess rituximab's long-term effect after B cell recovery. Patients were randomly assigned to receive either rituximab (375 mg/m<sup>2</sup>, maximum 500 mg, once weekly for 2 weeks) or placebo. The primary endpoint was the relapse-free period. Of 43 randomized patients, 40 received the intervention (18 rituximab, 22 placebo). The relapse-free period during the 1-year trial was significantly longer in the rituximab vs. placebo groups (median: 285 vs. 81 days; p < 0.001). Infusion reactions were more frequent in the rituximab group (p < 0.001), with no difference in adverse events incidence between the groups. Interestingly, the follow-up study demonstrated markedly higher 3-year cumulative relapse-free survival probability without further treatments in the rituximab vs. placebo groups (38% vs. 9%). A mini-systematic review with meta-analyses supported the findings. Rituximab is effective and well-tolerated, potentially leading to long-term remission with substantially high rates after B cell recovery for childhood-onset uncomplicated FRNS/SDNS. Trial registration JSKDC10, Clinical Trials Registry ID: jRCT1091220380; JSKDC10 follow-up study, Clinical Trials Registry ID: jRCT1050230024 [ABSTRACT FROM AUTHOR]
ISSN:20452322
DOI:10.1038/s41598-025-19214-0