Mycophenolate Mofetil after Rituximab for Childhood-Onset Complicated Frequently-Relapsing or Steroid-Dependent Nephrotic Syndrome

美罗华 医学 中止 内科学 肾病综合征 危险系数 不利影响 安慰剂 随机对照试验 胃肠病学 置信区间 病理 替代医学 淋巴瘤
作者
Kazumoto Iijima,Mayumi Sako,Mari S. Oba,Seiji Tanaka,Riku Hamada,Tomoyuki Sakai,Yoko Ohwada,Takeshi Ninchoji,Takehira Yamamura,Haruhiko Machida,Yuko Shima,Ryojiro Tanaka,Hiroshi Kaito,Yoshinori Araki,Tamaki Morohashi,Naonori Kumagai,Yoshimitsu Gotoh,Yohei Ikezumi,Takuo Kubota,Koichi Kamei,Naoya Fujita,Yasufumi Ohtsuka,Takayuki Okamoto,Takeshi Yamada,Eriko Tanaka,Masaki Shimizu,Tomoko Horinouchi,Akihide Konishi,Takashi Omori,Koichi Nakanishi,Kenji Ishikura,Shuichi Ito,Hidefumi Nakamura,Kandai Nozu
出处
期刊:Journal of The American Society of Nephrology 卷期号:33 (2): 401-419 被引量:30
标识
DOI:10.1681/asn.2021050643
摘要

Significance Statement Rituximab is the standard therapy for childhood-onset complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS). However, most patients redevelop FRNS/SDNS after peripheral B cell recovery. This multicenter, randomized, double-blind, placebo-controlled trial was conducted to examine whether mycophenolate mofetil (MMF) administration after rituximab can prevent treatment failure (FRNS, SDNS, steroid resistance, or use of immunosuppressive agents or rituximab) in these patients. MMF after rituximab decreased the risk of treatment failure during the MMF administration period by 80% and was well tolerated. However, after MMF discontinuation, the relapse-preventing effect disappeared, and most patients in the MMF group presented with treatment failure. In conclusion, MMF maintenance therapy after rituximab may be an option for sustaining remission in children with complicated FRNS/SDNS. Background Rituximab is the standard therapy for childhood-onset complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS). However, most patients redevelop FRNS/SDNS after peripheral B cell recovery. Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial to examine whether mycophenolate mofetil (MMF) administration after rituximab can prevent treatment failure (FRNS, SDNS, steroid resistance, or use of immunosuppressive agents or rituximab). In total, 39 patients (per group) were treated with rituximab, followed by either MMF or placebo until day 505 (treatment period). The primary outcome was time to treatment failure (TTF) throughout the treatment and follow-up periods (until day 505 for the last enrolled patient). Results TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median, 784.0 versus 472.5 days, hazard ratio [HR], 0.59; 95% confidence interval [95% CI], 0.34 to 1.05, log-rank test: P =0.07). Because most patients in the MMF group presented with treatment failure after MMF discontinuation, we performed a post-hoc analysis limited to the treatment period and found that MMF after rituximab prolonged the TTF and decreased the risk of treatment failure by 80% (HR, 0.20; 95% CI, 0.08 to 0.50). Moreover, MMF after rituximab reduced the relapse rate and daily steroid dose during the treatment period by 74% and 57%, respectively. The frequency and severity of adverse events were similar in both groups. Conclusions Administration of MMF after rituximab may sufficiently prevent the development of treatment failure and is well tolerated, although the relapse-preventing effect disappears after MMF discontinuation.
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