Basu B, et al. - Among children with the corticosteroid-dependent nephrotic syndrome (CDNS), the efficacy of rituximab and tacrolimus in maintaining relapse-free survival was compared in this analysis. Researchers reported that rituximab was more effective than tacrolimus in maintaining disease remission and minimizing corticosteroid exposure and could be considered as a first-line corticosteroid-sparing therapy in children with CDNS.

Methods

• It was a parallel-arm, open-label, randomized clinical trial.
• This trial was performed from May 8, 2015, to September 20, 2016, with 1-year follow-up in a single-center, tertiary care unit.
• An aggregate of 176 consecutive children aged 3 to 16 years with CDNS not previously treated with corticosteroid-sparing agents were screened for eligibility.
• The children received either tacrolimus (along with tapering alternate-day prednisolone) for 12 months or a single course of rituximab (2 infusions of 375 mg/m²) was the main intervention.
• Twelve-month relapse-free survival in the intention-to-treat population was the main outcome and measure.

Results

• According to the findings obtained, of the 176 children screened for eligibility, 120 were randomized and all but 3 subjects completed 1 year of follow-up.
• Data reported that the groups were comparable, with mean (SD) age of 7.2 (2.8) years, 32 boys (53.3%) in each group, mean (SD) disease duration of 2.5 (1.5) years and 2.3 (1.7) in the tacrolimus and rituximab groups, respectively, disease duration less than 1 year among 15 children (25.0%) in each group, median (interquartile range) of 4 (3-5) relapses in each group, and mean (SD) cumulative prednisolone dose of 246 (48) mg/kg and 239 (52) mg/kg in the prestudy year in the tacrolimus and rituximab groups, respectively.
• It was observed that rituximab therapy was correlated with a higher 12-month relapse-free survival rate than tacrolimus (54 [90.0%] vs 38 [63.3%] children; P < .001; odds ratio, 5.21; 95% CI, 1.93-14.07).
• In the rituximab group, median time to first relapse was 40 weeks and in the tacrolimus group, median time to first relapse was 29 weeks among the patients who experienced relapse.
• Compared with 10 subjects in the tacrolimus group, only 2 subjects in the rituximab group had more than 1 relapse during the study period.
• Compared with tacrolimus (mean [SD], 25.8 [27.8] vs 86.3 [58.0] mg/kg), the cumulative corticosteroid dose during the 12-month study period was lower with rituximab.
• Findings revealed that mild to moderate infections were twice as common in the tacrolimus group (26 [43.3%] vs 13 [21.7%] events) although both treatments were well tolerated.