REGENCY
Trial question
What is the effect of obinutuzumab, an anti-CD20 monoclonal antibody, in patients with active lupus nephritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
85.0% female
15.0% male
N = 271
271 patients (229 female, 42 male).
Inclusion criteria: adult patients aged 18-75 years with active lupus nephritis who were receiving oral prednisone.
Key exclusion criteria: eGFR < 30 mL/min/1.73 m² or end-stage kidney disease necessitating dialysis or transplantation; active infection; receipt of anti-CD20 therapy during or within 9 months before screening; receipt of cyclophosphamide, tacrolimus, cyclosporine, or voclosporin therapy during or within 2 months before screening.
Interventions
N=135 obinutuzumab (one of two dose schedules of 1,000 mg on day 1 and at weeks 2, 24, 26, and 52, with or without an additional dose at week 50).
N=136 placebo (matching placebo).
Primary outcome
Complete renal response at week 76
46.4%
33.1%
46.4 %
34.8 %
23.2 %
11.6 %
0.0 %
Obinutuzumab
Placebo
Significant
increase ▲
NNT = 7
Significant increase in complete renal response at week 76 (46.4% vs. 33.1%; AD 13.4%, 95% CI 2 to 24.8).
Secondary outcomes
Significant increase in complete renal response at week 76, with prednisone taper to ≤ 7.5 mg/day between weeks 64-76 (42.7% vs. 30.9%; AD 11.9%, 95% CI 0.6 to 23.2).
Significant increase in urinary protein-to-creatinine ratio < 0.8 at week 76, with no intercurrent event (55.5% vs. 41.9%; AD 13.7%, 95% CI 2 to 25.4).
Significant decrease in the rate of death or renal-related event through week 76 (18.9% vs. 35.6%; ARD -16.8, 95% CI -27.4 to -6.2).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients aged 18-75 years with active lupus nephritis who were receiving oral prednisone, obinutuzumab was superior to placebo with respect to complete renal response at week 76.
Reference
Richard A Furie, Brad H Rovin, Jay P Garg et al. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025 Apr 17;392(15):1471-1483.
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