An international, multi-center study evaluated rituximab therapy in childhood steroid-resistant nephrotic syndrome.
In an international retrospective study of 246 children with steroid-resistant nephrotic syndrome, rituximab induced remission in a subset of patients and was generally safe, with complete remission after rituximab associated with favorable kidney survival and earlier treatment (shorter prior calcineurin-inhibitor exposure) linked to higher remission rates.
Background
The efficacy and safety of rituximab in childhood steroid-resistant nephrotic syndrome (SRNS) have remained unclear. This retrospective cohort study spanned 28 pediatric nephrology centers across 19 countries in Asia, Europe, North America, and Oceania to evaluate rituximab in this difficult-to-treat population.
Study design
The study enrolled 246 children (mean age 6.9 years; 136 boys; 57% focal segmental glomerulosclerosis), all in non-remission before rituximab, followed for a median of 32.4 months. Patients were analyzed by duration of calcineurin inhibitor (CNI) treatment before rituximab: 146 received CNIs for 6 months or more (CNI-resistant) and 100 for under 6 months. The primary outcome was complete or partial remission (CR/PR) per IPNA/KDIGO guidelines, with kidney failure and adverse events as secondary outcomes.
Key findings
Among CNI-resistant children, remission rates (CR/PR) were 26%, 35.6%, 35.1%, and 39.1% at 3, 6, 12, and 24 months. Among children treated with CNIs for under 6 months before rituximab, remission rates were higher at 42%, 52%, 54%, and 60% at the same time points. Non-remission and partial remission at 12 months, compared with complete remission, were associated with significantly worse kidney survival. Adverse events occurred in 30.5% of patients and most were mild.
Clinical implications
Rituximab enhances remission in a subset of children with SRNS and is generally safe, and achieving complete remission after rituximab is associated with favorable kidney outcomes. The higher remission rates seen when rituximab was given after shorter prior CNI exposure suggest that earlier use may be more effective, though the retrospective design warrants confirmation in prospective studies.
Category
Research
Source
Kidney International
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