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Obinutuzumab receives U.S. FDA approval for the treatment of lupus nephritis
On October 20, 2025, the U.S. Food and Drug Administration (FDA) approved obinutuzumab, an anti-CD20 monoclonal antibody, for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients.1
After four initial doses in the first year, obinutuzumab can be administered twice yearly, providing an effective and potentially more convenient treatment option than traditional targeted therapies.1 This approval is based on positive results from the phase II NOBILITY (NCT02550652) and phase III REGENCY (NCT04221477) trials.1
REGENCY trial key data
The REGENCY trial is a phase III, randomized, controlled trial, evaluating the efficacy and safety of obinutuzumab plus standard therapy in patients with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V (N = 271).1,2 Patients received obinutuzumab (1,000 mg on Day 1 and at Weeks 2, 24, 26, and 52, with or without a dose at Week 50; n = 135), or placebo (n = 136).2
- At Week 76, 46.4% of patients in the obinutuzumab group achieved a complete renal response compared with 33.1% of those in the placebo group (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 2.0–24.8; p = 0.02).2
- A complete renal response at Week 76 with a prednisone dose of ≤7.5 mg per day between Weeks 64 and 76 was observed in 42.7% of patients in the obinutuzumab group vs 30.9% of patients in the placebo group (adjusted difference, 11.9 percentage points; 95% CI, 0.6–23.2; p = 0.04).2
- Urinary protein-to-creatinine ratio <0.8 without an intercurrent event was 55% in the obinutuzumab group vs 41.9% in the placebo group (adjusted difference, 13.7 percentage points; 95% CI, 2.0–25.4; p = 0.02).2
- No unexpected safety signals were reported.2
Following positive results from the phase II NOBILITY and phase III REGENCY studies, U.S. FDA approval of obinutuzumab marks an important clinical development for patients with lupus nephritis.
References
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