Abstract: PO1422
Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing Based on B Cell Reconstitution vs. a Serologic ANCA Flare (MAINTANCAVAS)
Session Information
- Glomerular Diseases: Immunology and Inflammation in Vasculitis and Lupus Nephritis
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1202 Glomerular Diseases: Immunology and Inflammation
Authors
- Zonozi, Reza, Massachusetts General Hospital, Boston, Massachusetts, United States
- Jeyabalan, Anushya, Massachusetts General Hospital, Boston, Massachusetts, United States
- Nithagon, Pravarut, Massachusetts General Hospital, Boston, Massachusetts, United States
- Laliberte, Karen A., Massachusetts General Hospital, Boston, Massachusetts, United States
- Cortazar, Frank B., New York Nephrology Vasculitis and Glomerular Center, Albany, New York, United States
- Niles, John, Massachusetts General Hospital, Boston, Massachusetts, United States
Group or Team Name
- MGH Vasculitis and Glomerulonephritis Center (MGH VGC)
Background
ANCA vasculitis is caused by autoantibodies to proteinase 3 (PR3) or myeloperoxidase (MPO). Rituximab (RTX), an anti-CD20 monoclonal, is effective at induction and maintenance of remission. However, RTX is associated with adverse events; hypogammaglobulinemia, infections, and late onset of neutropenia. The ideal strategy for long-term maintenance of remission remains unknown.
Methods
This is an interim analysis of an open-label, single center, randomized, two-arm controlled trial (ClinicalTrials.gov Identifier: NCT02749292) to evaluate maintenance of remission strategies that provides the best relapse-free survival in patients with ANCA vasculitis at 36 months. We enrolled subjects with ANCA vasculitis on RTX-induced continuous B cell depletion for a minimum of two years to one of two arms as follows: intermittent B cell depletion with RTX re-dosing upon (1) B cell return ( ≥ 10 B cells/mm3) or (2) upon a significant ANCA titer increase. The primary outcome was number of relapses defined by a Birmingham Vasculitis Activity Score (BVAS/WG) ≥ 2. Other outcomes, including serologic relapse and serious adverse events are not included in this analysis.
Results
From May 2016 to June 2021, 113 patients (mean age, 61 years; 48% women) were randomized, 57 to the ANCA arm and 56 to the B cell group. 52 patients were positive for anti-MPO, and 61 for anti-PR3. Relapse-free survival estimates at month 60 were 76% (95% CI, 62% to 86%) and 91% (95% CI, 74% to 97%) in the ANCA and B cell groups, respectively (hazard ratio of 3.85 (CI, 1.40 to 10.60) (P = 0.024 by logrank).
Conclusion
B cell driven RTX dosing appears to be highly efficacious at preventing relapses compared to ANCA titer driven dosing. Full trial analysis, including differences in adverse events, is needed to balance the benefit of reduced relapses against the infectious complications that may be associated with increased RTX use.
Funding
- Private Foundation Support