The efficacy and safety of rituximab in treating childhood nephrotic syndrome: an Italian perspective

Table 1 Basic characteristics of included studies. The intervention group comprised patients treated with rituximab plus prednisone and/or CIs, while the control group contained patients on prednisone and/or CIs. The end-point of our meta-analysis was the percentage of patients in remission at 6 months

First author, year (Reference)	Study design	Intervention group (n)	Control group (n)	Age intervention group/age control group, yr, mean	Male/Female patients, n/n	Intervention
Ravani et al. 2015 [6].	Single-centre, RCT	RTX (15)	Corticosteroid therapy (15)	6.9/6.9	19/11	All patients were maintained in remission with high prednisone doses (>0.7 mg/kg per day) Treatment group - RTX (one infusion of 375 mg/m2) - prednisone was tapered off by 0.3 mg/kg per week if proteinuria was <1 g/d. Control group - prednisone (mean dose 49 mg/m2 per day)
Ravani et al. 2011 [5]	Single-centre, RCT	RTX (27)	Corticosteroid + CIs therapy (27)	10.2/11.3	43/11	Treatment group - RTX (one or two infusion of 375 mg/m2) - chlorfenamine maleate - methyl prednisolone - paracetamol - prednisone was tapered off by 0.3 mg/kg per week if proteinuria was <1 g/d. Control group - prednisone and CIs (tapered off by 0.3 mg/kg per week if proteinuria was <1 g/d.)
Iijima et al. 2014 [7]	Multicentre, RCT	RTX (24)	Corticosteroid therapy (24)	11.5/13.6	34/14	Treatment group - RTX an intravenous dose of 375 mg/m2 (maximum 500 mg) once weekly for 4 weeks. - Methylprednisolone - Acetaminophen - d-chlorpheniramine maleate Control group - prednisolone (60 mg/m2 orally three times a day (maximum of 80 mg per day) for 4 weeks, and then tapered over 6 weeks.
Ahn et al. 2013 [8]	Multicentre, RCT	RTX (35)	Corticosteroid + CIs therapy (18)	13/NA	NA/NA	Treatment group - single dose of intravenous RTX (375 mg/m2) Control group - corticosteroid therapy

FRNS or SDNS were defined complicated as follows: a) children when aged 2 years or older, who had ≥4 relapses in a 12-month period or steroid dependence at any point in the 2 years before relapse at screening, after completion of immunosuppressive drug treatment (e.g., ciclosporin, cyclophosphamide, mizoribine, or mycophenolate mofetil); or b) children when aged 2 years or older, who had ≥4 relapses in a 12-month period or steroid dependence diagnosed at any point in the 2 years before relapse at screening, during immunosuppressive drug treatment (e.g., ciclosporin, cyclophosphamide, mizoribine, or mycophenolate mofetil); or c) patients with a history of SRNS and diagnosed with FRNS or SDNS when aged 2 years or older, who had ≥4 relapses in a 12-month period or steroid dependence at any point in the 2 years before relapse at screening, during or after the completion of immunosuppressive drug treatment (e.g., ciclosporin or a combination of ciclosporin and methylprednisolone)
Abbreviations: CIs calcineurin inhibitor, RTX rituximab, NA not available

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