タナカ　リョウジロウ   Ryojiro Tanaka   田中　亮二郎    所属   川崎医科大学  医学部 臨床医学　小児科学    職種   特任教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	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.
掲載誌名	正式名：Scientific reports 略　 称：Sci Rep ISSNコード：20452322/20452322
掲載区分	国外
巻・号・頁	15(1),pp.34306
著者・共著者	Kazumoto Iijima, Mayumi Sako, Tomoko Horinouchi, Tomoyuki Sakai, Tomohiko Yamamura, Riku Hamada, Yasufumi Ohtsuka, Seiji Tanaka, Koichi Kamei, Ryojiro Tanaka, Yuji Kano, Takuo Kubota, Yuko Shima, Tamaki Morohashi, Aya Inaba, Shuichiro Fujinaga, Masafumi Oka, Hiroshi Kaito, Akihide Konishi, China Nagano, Koichi Nakanishi, Kenji Ishikura, Shuichi Ito, Hidefumi Nakamura, Gian Marco Ghiggeri, Rintaro Mori, Takashi Omori, Kandai Nozu,
発行年月	2025/10
概要	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.
DOI	10.1038/s41598-025-19214-0
PMID	41073503