Lupus & antiphospholipid syndrome
Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis
Primary result · Complete renal responseResult — go to the resultAdjusted difference 13.4 percentage points 95% CI 2.0–24.8Authors' conclusion
Among adults with active lupus nephritis, obinutuzumab plus standard therapy was more efficacious than standard therapy alone in providing a complete renal response.
Study context
- Population
- Adults with biopsy-proven active LN
- Participants
- 271 adults
- Comparison
- Obinutuzumab plus standard therapy vs placebo plus standard therapy
- Obinutuzumabn = 135
- Placebon = 136reference
- Primary endpoint
- Complete renal response: urinary protein-to-creatinine ratio <0.5, eGFR ≥85% of baseline, no intercurrent event (rescue therapy, treatment failure, death or early withdrawal)
- Follow-up
- Week 76
Methodological detailsphase 3, 1:1 randomisation
- Phase 3
- 1:1 randomisation
Primary result
Complete renal response
Adjusted difference
13.4 percentage points
95% CI 2.0–24.8
P = 0.02
By group
Obinutuzumabvs Placebo
adjusted difference 13.4 percentage points (95% CI 2.0–24.8); P = 0.02
As reported in the abstract
Secondary outcomes
| Outcome | Obinutuzumab | Placebo | Adjusted difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Key secondary: complete renal response with prednisone ≤7.5 mg/day between weeks 64 and 76 · week 76 | 42.7% | 30.9% | 11.9 (0.6–23.2) | P = 0.04 | |
| Key secondary: urinary protein-to-creatinine ratio <0.8 without an intercurrent event · week 76 | 55.5% | 41.9% | 13.7 (2.0–25.4) | P = 0.02 | |
| −2002040Difference, percentage points (linear scale) |
Original publication
Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. Published 7 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →