Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children
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ORIGINAL ARTICLE
Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children Koichi Kamei & Shuichi Ito & Kandai Nozu & Shuichiro Fujinaga & Makiko Nakayama & Mayumi Sako & Mari Saito & Maki Yoneko & Kazumoto Iijima
Received: 12 February 2009 / Revised: 25 March 2009 / Accepted: 26 March 2009 / Published online: 7 May 2009 # IPNA 2009
Abstract We conducted a multicenter prospective trial to evaluate the efficacy, safety and pharmacokinetics of a single dose of rituximab (375 mg/m2 body surface area) for the treatment of children with refractory steroid-dependent nephrotic syndrome (SDNS). All patients (n=12) were able to discontinue steroids at a median of 74 days after treatment. The frequency of relapses per 6 months was significantly reduced and the steroid-free period per 6 months was significantly increased after treatment compared with those before treatment. The condition in nine of the patients (75%) relapsed at a median of 129 days after treatment, and seven patients were given additional rituximab due to steroid dependency. Most of the relapses developed simultaneously with recovery of B-cells. However, three patients (25%) did not have a relapse with B-cell recovery and the disease was kept in remission for more than 1 year. None of the patients K. Kamei : S. Ito : M. Nakayama : M. Sako : K. Iijima Department of Nephrology, National Center for Child Health and Development, Tokyo, Japan K. Kamei Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan
S. Ito Department of Pediatrics, Yokohama City University Medial Center, Yokohama, Japan
K. Nozu Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan
developed life-threatening adverse events. This is the first report of a prospective study of a single dose of rituximab for refractory SDNS. Treatment with a single dose of rituximab may be effective for refractory SDNS, but its efficacy to prevent relapses was transient in most of the patients. Keywords Refractory steroid-dependent nephrotic syndrome . Children . Clinical trial . Rituximab . Pharmacokinetics
Introduction Idiopathic nephrotic syndrome is the most frequent glomerular disease of childhood. Most cases respond to steroid treatment, but approximately 40% of the children develop S. Fujinaga Department of Nephrology, Saitama Children’s Medical Center, Saitama, Japan M. Saito Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Science and Nursing, University of Tokyo, Tokyo, Japan M. Yoneko Division of Clinical Research, National Center for Child Health and Development, Tokyo, Japan K. Iijima (*) Division of Child Health and Development, Department of Pediatrics, Kobe University Graduate School of Medicine, 5-1 Kusunoki-cho 7 chome, Chuo-ku, Kobe 650-0017, Japan e-mail: [email protected]
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frequent-relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome (SDNS). In Japan these patients are usually treated with immunosuppressants such as cyclospori
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