Long-Term Efficacy and Safety of Rituximab Versus Tacrolimus in Children With Steroid Dependent Nephrotic Syndrome

IntroductionIn the Rituximab for Relapse Prevention in Nephrotic Syndrome (RITURNS) trial, we demonstrated superior efficacy of single-course rituximab over maintenance tacrolimus preventing relapses children with steroid dependent nephrotic syndrome (SDNS) during a 1-year observation. Here present long-term outcomes all 117 trial completers, who were followed up another 2 years.MethodsRelapsing patients arm received second course rituximab, either (n = 44) or without mycophenolate mofetil (MMF) cotreatment 15). In arm, line monotherapy was initiated after 32) electively 24).ResultsAll 12-month relapse-free relapsed postexposure year, resulting similar median survival times arms (62 vs. 59 weeks). Second less effective than first-line therapy switched to following relapse (relapse-free 55 63 weeks, P < 0.01). B-cell counts 6 months post-rituximab predicted risk both first and therapy. MMF yielded much improved 2-year as compared (67% 9%, 0.0001). Higher grade adverse event rates observed versus on (0.87 0.53 per year).ConclusionThe therapeutic effect SDNS vanishes year post-exposure. appears yield longer remission when applied Maintenance induces disease remission. years. Relapsing 24). All year). The