The following is a summary of “Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis,” published in the February 2025 issue of New England Journal of Medicine by Furie et al.
Researchers conducted a retrospective study on obinutuzumab in lupus nephritis and found it provided better renal responses than placebo in a phase 2 trial.
They conducted a phase 3 randomized trial, assigning adults with biopsy-proven lupus nephritis 1:1 to receive obinutuzumab (1000 mg on day 1, weeks 2, 24, 26, and 52, with or without week 50) or placebo. All received mycophenolate mofetil and prednisone (7.5 mg/day by week 12, 5 mg/day by week 24). The primary end point was a complete renal response at week 76, defined by a urinary protein-to-creatinine ratio <0.5, an eGFR ≥85% of baseline, and no intercurrent event. Secondary end points included complete renal response with prednisone ≤7.5 mg/day between weeks 64–76 and a urinary protein-to-creatinine ratio <0.8 without an intercurrent event.
The results showed that among 271 patients, a complete renal response at week 76 occurred in 46.4% with obinutuzumab and 33.1% with placebo (adjusted difference, 13.4 points; 95% confidence interval (CI), 2.0–24.8; P=0.02). More patients achieved a complete renal response with prednisone ≤7.5 mg/day between weeks 64–76 in the obinutuzumab group than in the placebo group (42.7% vs. 30.9%; adjusted difference, 11.9 points; 95% CI, 0.6–23.2; P=0.04). A urinary protein-to-creatinine ratio <0.8 without an intercurrent event was more common with obinutuzumab (55.5% vs. 41.9%; adjusted difference, 13.7 points; 95% CI, 2.0–25.4; P=0.02). Serious adverse events (AEs), mainly infections and COVID-19–related events, were higher with obinutuzumab.
Investigators found that obinutuzumab plus standard therapy was more effective than standard therapy alone in achieving a complete renal response in adults with active lupus nephritis.
Source: nejm.org/doi/full/10.1056/NEJMoa2410965
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