Lupus & antiphospholipid syndrome
Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus
Primary result · SRI-4 responseResult — go to the resultAdjusted difference 23.1 percentage points 95% CI 12.5–33.6Authors' conclusion
Among adults with active SLE, treatment with obinutuzumab was superior to placebo with respect to the primary and all key secondary end points.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE) without proliferative or membranous LN receiving standard therapyrandomised
- Participants
- 303 adults
- Comparison
- Obinutuzumab 1000 mg vs placebo on day 1 and weeks 2, 24 and 26, with standard therapy
- Obinutuzumabn = 151
- Placebon = 152reference
- Primary endpoint
- SRI-4 response (≥4-point reduction in SLEDAI-2K, no worsening on BILAG 2004 and PGA, no intercurrent events)
- Follow-up
- Week 52
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
SRI-4 response
Adjusted difference
23.1 percentage points
95% CI 12.5–33.6
P < 0.001
By group
As reported in the abstract
Secondary outcomes
SRI-4 response, additional analysis whereby nonfatal intercurrent events did not affect response status · week 52
- SRI-4 response, obinutuzumab vs placebo, respective percentages
- 85.4% and 68.5%
- Adjusted difference, obinutuzumab vs placebo, percentage points
- 16.8 (95% CI 7.1 to 26.4)
- Additional analysis
Key secondary end points: British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment response, sustained reduction in GC dose, sustained SRI-4 response, SRI-6 response, time to first BILAG-defined flare
- Obinutuzumab superior to placebo for all key secondary end points
Safety
Adverse events
Serious adverse events
Original publication
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