Abstract: SA-OR051
Curing Lupus Nephritis: Stable Drug-Free Remission After an Intensified B-Cell Depletion Regimen as Compared with Standard of Care: Results from the INTONATE Randomized Trial
Session Information
- Glomerular Diseases: Clinical Trial Results
October 24, 2026 | Location: Mile High Ballroom 4A, Convention Center
Abstract Time: 05:20 PM - 05:30 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Roccatello, Dario, Ospedale San Giovanni Bosco, Turin, Piedmont, Italy
- Sciascia, Savino, Ospedale San Giovanni Bosco, Turin, Piedmont, Italy
- Fenoglio, Roberta, Ospedale San Giovanni Bosco, Turin, Piedmont, Italy
Background
Lupus nephritis (LN) remains a major cause of morbidity despite advances in immunosuppressive therapy, with most patients requiring prolonged treatment and exposure to immunosuppressants and glucocorticoids. Strategies enabling durable remission while minimizing treatment burden are urgently needed
Methods
INTONATE is a multicenter, open-label, randomized controlled trial comparing intensified B-cell depletion therapy (IBCDT) with standard therapy consisting of glucocorticoids plus mycophenolate mofetil (GC+MMF) in patients with biopsy-proven class III, IV, or V LN. Patients were randomized 1:1 and followed for 30 months. The primary endpoint was complete renal response at 12 months. Secondary outcomes included overall renal response, glucocorticoid exposure, immunological response, renal flares, and sustained remission at 30 months
Results
Fifty four patients were randomized (27 per group). At 12 months, complete renal response was achieved in 16/27 patients (59.3%) receiving IBCDT and 13/27 (48.1%) receiving GC+MMF (p=0.41), with overall renal response in 81.5% and 70.4%, respectively (p=0.34). IBCDT was associated with markedly reduced glucocorticoid exposure (median cumulative dose 1.42 g vs 3.05 g; p<0.001) and greater immunological improvement, including higher rates of anti dsDNA reduction (81% vs 56%; p=0.047). At 30 months, complete renal response was observed in 19/27 (70%) and 16/27 (59%) patients, respectively (p=0.39), with lower flare rates in the IBCDT group (7% vs 19%; p=0.23). Notably, remission in the IBCDT group was achieved without maintenance immunosuppression. Time to event analyses consistently favored IBCDT for faster response and improved flare free survival
Conclusion
Intensified B-cell depletion therapy achieves comparable renal outcomes to standard therapy while substantially reducing immunusuppressants and glucocorticoid exposure and eliminating the need for maintenance immunosuppression. These findings support a paradigm shift toward finite, steroid-sparing treatment strategies in lupus nephritis