Manel Jellouli1, Rim Charfi2, Bayen Maalej3, Abdelmajid Mahfoud3, Sameh Trabelsi2, Tahar Gargah4. 1. Department of Pediatric Nephrology, Charles Nicolle Hospital, Faculty of Medicine of Tunis, Tunis El Manar University, Tunis, Tunisia. Electronic address: maneljellouli@yahoo.fr. 2. Department of Clinical Pharmacology, National Center of Pharmacovigilance, Faculty of Medicine of Tunis, Clinical and Experimental Pharmacology Laboratory LR16SP02, Tunis El Manar University, Tunis, Tunisia. 3. Department of Pediatrics, Pediatric Emergency and Intensive Care, Hedi Chaker Hospital, Sfax, Tunisia. 4. Department of Pediatric Nephrology, Charles Nicolle Hospital, Faculty of Medicine of Tunis, Tunis El Manar University, Tunis, Tunisia.
Abstract
OBJECTIVES: To evaluate the efficacy and safety of rituximab in children with steroid-resistant nephrotic syndrome. STUDY DESIGN: A systematic review evaluating the efficacy and safety of rituximab in children with steroid-resistant nephrotic syndrome was performed. Data from studies, performed before April 2017 were collected, from MEDLINE, Cochrane Library, Scopus, and Web of Science. Study eligibility criteria included clinical trials and observational studies with a minimal sample size of 5 patients, regarding treatment with rituximab in children with steroid-resistant nephrotic syndrome. Independent extraction of articles by 2 investigators using predefined data fields was performed. RESULTS: We included 7 case series and 1 open-label randomized controlled trial. Among them, 3 studies were multicenter. A total of 226 patients were included. Mean age at onset was 5.6 ± 1.1 years. Mean number of rituximab administrations was 3.1 ± 1.1 infusions per patient. Remission was observed in 89 patients (46.4%). Remission was seen in 40.8% patients with initial steroid-resistant nephrotic syndrome and 52.8% patients with late steroid-resistant nephrotic syndrome. Good initial response to rituximab therapy was observed in 63.2% patients with minimal change nephrotic syndrome, 39.2% patients with focal and segmental glomerulosclerosis, 1 patient had diffuse mesangial hypercellularity, and 1 patient had IgM nephropathy. Sustained remission ranged from 18% to 93.7%. Five serious adverse events were observed. CONCLUSIONS: Rituximab exhibited a satisfactory profile regarding efficacy and safety indicating that this agent is a promising therapy for steroid-resistant nephrotic syndrome and should be further investigated by randomized clinical trials.
OBJECTIVES: To evaluate the efficacy and safety of rituximab in children with steroid-resistant nephrotic syndrome. STUDY DESIGN: A systematic review evaluating the efficacy and safety of rituximab in children with steroid-resistant nephrotic syndrome was performed. Data from studies, performed before April 2017 were collected, from MEDLINE, Cochrane Library, Scopus, and Web of Science. Study eligibility criteria included clinical trials and observational studies with a minimal sample size of 5 patients, regarding treatment with rituximab in children with steroid-resistant nephrotic syndrome. Independent extraction of articles by 2 investigators using predefined data fields was performed. RESULTS: We included 7 case series and 1 open-label randomized controlled trial. Among them, 3 studies were multicenter. A total of 226 patients were included. Mean age at onset was 5.6 ± 1.1 years. Mean number of rituximab administrations was 3.1 ± 1.1 infusions per patient. Remission was observed in 89 patients (46.4%). Remission was seen in 40.8% patients with initial steroid-resistant nephrotic syndrome and 52.8% patients with late steroid-resistant nephrotic syndrome. Good initial response to rituximab therapy was observed in 63.2% patients with minimal change nephrotic syndrome, 39.2% patients with focal and segmental glomerulosclerosis, 1 patient had diffuse mesangial hypercellularity, and 1 patient had IgM nephropathy. Sustained remission ranged from 18% to 93.7%. Five serious adverse events were observed. CONCLUSIONS:Rituximab exhibited a satisfactory profile regarding efficacy and safety indicating that this agent is a promising therapy for steroid-resistant nephrotic syndrome and should be further investigated by randomized clinical trials.
Authors: Michelle A Hladunewich; Dan Cattran; Sanjeev M Sethi; Salim S Hayek; Jing Li; Changli Wei; Sarah I Mullin; Heather N Reich; Jochen Reiser; Fernando C Fervenza Journal: Kidney Int Rep Date: 2021-10-30