Kidney Week

Abstract: FR-PO871

Membranous Nephropathy: Efficacy of Low or Standard Rituximab-Based Protocols and Comparison to the Ponticelli Regimen

Session Information

• Glomerular Diseases: Membranous Nephropathy, SLE, Complement
  November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

• Fenoglio, Roberta, Center of Research of Immunopathology and Rare Diseases (CMID), Division of Clinical Immunology, Giovanni Bosco Hospital and University of Turin, Ita, Turin, Italy, Italy

Roberta Fenoglio,

• 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

Savino Sciascia,

• Roccatello, Dario, Center of Research of Immunopathology and Rare Diseases (CMID), Division of Clinical Immunology, Giovanni Bosco Hospital and University of Turin, Ita, Turin, Italy, Italy

Dario Roccatello,

Background

About 80% of patients (pts) with primary Membranous nephropathy (PMN) have an autoimmune disease caused by autoantibodies and 75% of them have antibodies direct against the M-type phospholipase A2 receptor (PLA2R) present in podocytes. Immunosuppressive treatment is recommended in high-medium risk pts. Recently the use of rituximab (RTX), has emerged as an important therapeutic option in pts with PMN. The appropriate dose, the number of doses of RTX in MN pts is still uncertain. Few investigators have reported conflicting outcomes with low-dose of RTX. No randomized clinical trials have been performed so far to compare the efficacy and safety profiles of low-dose RTX (Protocol 1, one dose of RTX 375 mg/m²) with standard dose RTX (Protocol 2, four weekly doses of Rituximab 375 mg/m²) and Ponticelli regimen (PR). Waiting for the results of controlled trials that compare the efficacy of RTX with other therapeutic approaches in primary MN or different RTX regimens, we report our experience comparing 3 different treatment protocols. Our working hypothesis was that the efficacy of RTX was comparable to that of PR even at low dose.

Methods

32 consecutive pts with PMN and nephrotic syndrome were included and received RTX (14 pts treated with Protocol 1; 17 with Protocol 2). All patients were followed for 24 months after RTX. 17 pts treated with PR were included as controls and matched with cases for age and baseline proteinuria. No statistical differences were observed among groups in baseline sCr and Proteinuria

Results

At 24 months, we observed a statistical significant improvement in terms of proteinuria levels in pts treated with Protocol 1 (7.5 +/- 4.8 at T0; 0.21 +/- 0.15 at T24, p<0.01) protocol 2 (5.1+/-1.41 g/24 at T0; 0.35 +/- 0.39 at T24 p<0.01) and in the controls (8.27 +/- 4.78 T0; 2.2 +/- 1.9 g/24h at T24, p<0.01). When comparing the 3 groups, we observed no differences in clinical response (p=0.53). No statistical significant change in sCr levels was observed, at baseline and during the follow-up.

Conclusion

Our data suggest that the RTX is a promising alternative to Ponticelli’s protocol even at low-doses. RTX has the potential to be a cost-effective treatment in the short and medium terms despite the high single dose cost. The use of low dose can provide a further significant reduction in treatment.