Results from the regency trial assessing efficacy and safety of obinutuzumab in active lupus nephritis
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2025
Autores
Rovin, Brad
Furie, Richard
Garg, Jay
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International Society of Nephrology (ISN)
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Introduction: Obinutuzumab, a humanized type II anti-CD20 mono clonal antibody, is approved for B-cell malignancies. In the Phase II
NOBILITY trial of patients with active lupus nephritis
(LN;NCT02550652), study participants receiving obinutuzumab in
addition to standard therapy were significantly more likely to
achieve complete renal response than those receiving placebo in
addition to standard therapy. The results of the Phase III REGENCY
trial (NCT04221477), performed to verify NOBILITY, are presented
here.
Methods: REGENCY, a Phase III, double-blind placebo-controlled
trial, randomized adults with biopsy-proven active proliferative
LN 1:1 to placebo or one of two intravenous obinutuzumab dosing
schedules (1000 mg: Day 1, Weeks 2, 24, 26, 50 and 52) in
addition to standard therapy. The primary endpoint was complete
renal response (CRR, defined as urine protein-to-creatinine ratio
[UPCR] <0.5 g/g, estimated glomerular filtration rate [eGFR] $85%
of baseline and no intercurrent events of rescue therapy, treatment
failure, death or early study withdrawal) at Week 76 and assessed
in the intention-to-treat population. Key secondary endpoints
included CRR at Week 76 with successful prednisone taper to #7.5
mg/day between Weeks 64 and 76, and UPCR <0.8 g/g at Week 76
with no intercurrent events, change in eGFR from baseline to
Week 76 and renal-related events or death through Week 76.
Incidence and severity of adverse events through Week 76 were
compiled
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WCN25-3676 RESULTS FROM THE REGENCY TRIAL ASSESSING EFFICACY AND SAFETY OF OBINUTUZUMAB IN ACTIVE LUPUS NEPHRITIS Rovin, Brad et al. Kidney International Reports, Volume 10, Issue 2, S771 - S772
