Rituximab works as relapse prevention in adult nephrotic syndrome

Treatment with rituximab helps prevent relapse in adult patients with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS), as shown in a study.

The study included 72 patients (mean age 47.9 years, 56.1 percent female) with FRNS or SDNS who had urine protein of <0.3 g/gCr. They were randomly assigned to receive either intravenous rituximab at 375 mg/m² (n=36) or placebo (n=36) at weeks 1, 2, and 25. All patients were followed-up for 49 weeks.

The primary outcome was the number of patients who were free of relapse at the 49-week follow-up. Relapse was defined as urine protein of ≥1 g/gCr on two consecutive measurements.

A total of 66 patients (92 percent) received the study drug at least once and were included in analyses. At week 49, the proportion of patients who were relapse-free was 87.4 percent (95 percent confidence interval [CI], 69.8–95.1) with rituximab and 38 percent (95 percent CI, 22.1–53.8) with placebo (p<0.001). Furthermore, the median relapse-free time was significantly longer with rituximab vs placebo (49 vs 30.8 weeks).

Compared with placebo, rituximab reduced the risk of relapse by 84 percent (hazard ratio, 0.16, 95 percent CI, 0.05–0.46; p<0.001).

In terms of safety, the most common adverse effect was infusion reaction, occurring in 40.6 percent of patients in the rituximab group and 2.9 percent of those in the placebo group.