Cyclophosphamide and rituximab in frequently relapsing/steroid-dependent nephrotic syndrome

Webb, Hazel; Jaureguiberry, Graciana; Dufek, Stephanie; Tullus, Kjell; Böckenhauer, Detlef

doi:10.1007/s00467-015-3245-9

Cited by 38 publications

(28 citation statements)

References 20 publications

(24 reference statements)

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“…Two patients had neutropenia associated with transient viral infection [20]. Webb et al carried out a retrospective cohort study on 102 children who were treated with cyclophosphamide and/or rituximab [21]. These authors found that rituximab was associated with a longer remission time and fewer side effects than cyclophosphamide.…”

Section: Case Reports Case Series and Survey Studies Of Rituximab Fomentioning

confidence: 99%

Rituximab in steroid-sensitive nephrotic syndrome: lessons from clinical trials

et al. 2017

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Idiopathic nephrotic syndrome is the most common chronic glomerular disease in children. A total of 80–90% of patients with childhood idiopathic nephrotic syndrome achieve remission with steroid therapy [steroid-sensitive nephrotic syndrome (SSNS)]. However, approximately 50% of children with SSNS develop frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Children with FRNS or SDNS are usually treated with immunosuppressive agents, but 10–20% of children receiving immunosuppressive agents still show frequent relapses or steroid dependence during or after treatment, defined as complicated FRNS or SDNS. Rituximab, a chimeric anti-CD20 monoclonal antibody that was originally developed to treat patients with B-cell non-Hodgkin’s lymphoma, is currently used for treating SSNS. In this review we highlight recent studies, mainly randomized controlled trials of rituximab for SSNS, including complicated and uncomplicated forms of FRNS or SDNS in children. We also discuss the effects of these studies on the management of patients suffering from these conditions.

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Section: Case Reports Case Series and Survey Studies Of Rituximab Fomentioning

confidence: 99%

Rituximab in steroid-sensitive nephrotic syndrome: lessons from clinical trials

et al. 2017

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“…Then, we reviewed full-text of selected articles and removed 49 studies because the topics were not relevant to the subject. Finally, 17 investigations were included in the systematic review (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20). The flow diagram of study selection is shown in Figure 1.…”

Section: Search Results and Characteristicsmentioning

confidence: 99%

“…Rituximab (RTX) might be a hopeful treatment for refractory NS in children, but the long-term effects and cost-effectiveness of RTX treatment have not been fully assessed (3). Several studies have suggested RTX as a proper drug for the treatment of children with FRNS/SDNS (5)(6)(7)(8). This study aims to perform a systematic review to identify the efficacy and safety of RTX in children with difficult-to-treat NS.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of rituximab in children with difficult-to-treat nephrotic syndrome; a systematic review

Azarfar¹,

Ravanshad²,

Mehrad‐Majd³

et al. 2018

J Renal Inj Prev

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“…Three studies reported on both safety and effectiveness endpoints. One reported on treatment for primary nocturnal enuresis and had nights of dryness as an effectiveness endpoint; a second reported on treatment for juvenile idiopathic arthritis with disease progression as an effectiveness endpoint; and a third reported on nephrotic syndrome with prevention of relapse as an effectivenesss endpoint [26,48,50]. These three studies did not specify primary safety endpoints.…”

Section: Safety and Effectiveness Endpointsmentioning

confidence: 99%

Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review

Lasky

Carleton

Horton

et al. 2020

Drugs - Real World Outcomes

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Background The promise of real-world evidence (RWE) is especially relevant to pediatrics, where medicines prescribed for children are often used without evidence derived from randomized clinical trials. Objectives The aim of this systematic review was to describe the state of RWE in pediatrics by identifying observational studies published during 2016 that used RWE to assess medication safety or effectiveness in children. Methods An electronic search of PubMed was combined with an extended search of references within systematic reviews and expert suggestions. Studies were included if they reported on an infant or child under 18 years with exposure to medications; assessed safety or effectiveness; specified a comparison or control group, and were published in English in 2016. Data extraction was conducted by one team member using a standardized form and reviewed by a second team member. Study quality was assessed using the GRACE checklist for rating the quality of observational studies. Results After removing duplicates, 915 citations were screened and 29 studies met the eligibility criteria. Most of the eligible studies relied on primary data collection or chart review at a single institution and did not use the growing number of administrative or electronic health record databases available. One-quarter of the studies did not use well-established statistical methods to control for confounders. No single disease group or medication predominated, and age groups ranged from infants to adolescents. Conclusions A small body of observational studies published in 2016 were categorized by the study team as using real-world data to assess medication safety or effectiveness in children. Studies varied in age groups, diseases or conditions, and methods, and may not have fully met the FDA definition of RWE. Our review indicates that the use of RWE is not fully developed in pediatrics, and suggests an opportunity to further develop capabilities and more fully leverage administrative and electronic health record databases to study medication safety and effectiveness in children. Our systematic review appears generalizable to pediatrics broadly, and documents that the high level of activity in RWE in general has had less of an impact on pediatrics.

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Cyclophosphamide and rituximab in frequently relapsing/steroid-dependent nephrotic syndrome

Abstract: Rituximab was used in children with the most difficult to treat FRSDNS, yet was associated with longer remission time and less side effects than cyclophosphamide. A randomized controlled trial is needed to directly compare these drugs.

Cited by 38 publications

References 20 publications

Rituximab in steroid-sensitive nephrotic syndrome: lessons from clinical trials

Rituximab in steroid-sensitive nephrotic syndrome: lessons from clinical trials

Efficacy and Safety of rituximab in children with difficult-to-treat nephrotic syndrome; a systematic review

Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review

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