Abstract: SA-PO407
The Cyclophosphamide-Sparing Role of an Intensified B-Cells Depletion Protocol in ANCA-Associated Vasculitis: A Case-Control Study
Session Information
- Glomerular Diseases: Clinical, Outcomes, Trials - III
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Fenoglio, Roberta, Hospital Hub San Giovanni, Turin, Italy, Italy
- Sciascia, Savino, Center of Research of Immunopathology and Rare Diseases (CMID), Division of Clinical Immunology, Giovanni Bosco Hospital and University of Turin, Ita, Turin, Italy, Italy
- Roccatello, Dario, Ospedale San GIovanni Bosco, Torino, Italy
Background
ANCA-associated vasculitis (AAV) are systemic diseases with relapsing chronic course. The management of AAV requires the use of immunosuppressive drugs whose use is associated with potential toxicity. This case-control study aims to evaluate the immunosuppressive-sparing effect of rituximab (RTX) used with cyclophosphamide (CYC), compared to a traditional regimen based on high-dose CYC.
Methods
26 patients (pts) with AAV with a necrotising extracapillary glomerulonephritis were prospectively enrolled. 13 pts received the intensified protocol of B-lymphocyte depletion therapy (IBCDT) “4+2” with RTX and CYC (4 weekly infusions of RTX followed by 2 monthly followed by prednisone tapered to 5 mg/day in 3 months). 13 pts treated with the high-dose CYC treatment protocol followed by azathioprine as maintenance therapy were enrolled as controls.
Results
In the 13 cases treated with the IBCDT we observed a significant reduction in mean values of parameter of disease activity. After administration of RTX, a significant reduction of the mean s-creatinine values and BVAS was observed. All pts had full B-cell depletion on peripheral blood after the first IBCDT protocol after 1 year. No further maintenance therapy was given. In the cases, a response was observed in 8/13 cases. 4 pts did not respond and a death was observed for cardiovascular causes. No significant difference was observed in terms of response to therapy between the two groups. The IBCDT allows a significant reduction in the cumulative dose of CYC to which each patient was exposed during follow-up, reaching statistical significance levels (p <0.001). Calculated on a monthly basis, the "4+2" protocol allowed an average reduction in the CYC cumulative dose equivalent to 827 mg/month.
Conclusion
in a selected sample of patients with AAV with renal involvement, the IBCT regimen appeared to be non inferior in terms of the efficacy when compared to CYC-based standard regimens. Moreover, the IBCDT regimen allowed a net reduction in the cumulative average dose of CYC to which pts are exposed, quantifiable in approximately 1g/month.