Episode notes
DOI: 10.1056/NEJMoa2410965
Key Points:
- Phase 3 trial testing obinutuzumab (anti-CD20 monoclonal antibody) + standard therapy vs placebo + standard therapy for lupus nephritis
- Primary endpoint: Complete renal response at week 76
- Notable finding: 46.4% response with obinutuzumab vs 33.1% with placebo (13.4% improvement, p=0.02)
Trial Design:
- 271 adult patients with active lupus nephritis
- Randomized 1:1 to receive obinutuzumab or placebo
- All patients received standard therapy (mycophenolate mofetil + prednisone)
- Target prednisone dose: 7.5mg/day by week 12, 5mg/day by week 24
Key Results:
1. Primary Endpoint:
- Complete renal response at week 76 significantly better with obinutuzumab
- Lower intercurrent events with obinutuzumab (treatme ...