NEW ORLEANS -- In a randomized comparison, rituximab (Rituxan) proved non-inferior to cyclosporine for the treatment of idiopathic membranous nephropathy, a researcher reported here.
Preliminary results from the suggested that B-cell targeting with IV infusion rituximab was as effective as the pill cyclosporine in inducing remission of proteinuria during a year of treatment, according to Fernando C. Fervenza, MD, of the Mayo Clinic College of Medicine in Rochester, Minnesota.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Patients who received cyclosporine had a higher rate of treatment failure at 24 months compared with those who received rituximab (79.4% versus 37.5%), and complete or partial remission occurred in 62.5% of the rituximab cohort compared with 20.6% of those who received cyclosporine (odds ratio 6.0, 95% CI 2.7-13.2, P<0.0001), said Fervenza during presentation at ASN Kidney Week 2017.
"I think that you can conclude pretty clearly that B-cell targeting with rituximab is as effective as with cyclosporine ... It is an effective agent and prolongs remission," said co-author Daniel C. Cattran, MD, of the University of Toronto, during an ASN press event. "The no-brainer is that if you have a side effect with cyclosporine you should stop treatment, as there are a lot of advantages rituximab."
Kenar D. Jhaveri, MD, of Northwell Health in Great Neck, New York, told Ƶ that "the MENTOR trial is an important study in the management of membranous nephropathy and these findings will change standard of care for membranous nephropathy."
Jhaveri, who was not involved in the study, commented that it was was encouraging that the outcomes indicated a benefit with rituximab, but added "it is important to note that rituximab was not compared to cyclophosphamide-based therapies."
Fervenza's group randomized people from 25 participating institutions to receive cyclosporine (n=63) or rituximab (n=64) for a year, followed by a year of follow-up visits. Patients were not eligible if they had an active infection, a secondary cause of idiopathic membranous nephropathy, or type 1 or 2 diabetes.
Mean proteinuria at baseline was 10,329 mg/day in the cyclosporine group compared with 10,410 mg/day among those who received rituximab. Serum albumin was 2.6 g/dL and serum creatine was 1.3 mg/dL versus 2.7 g/dL and 1.2 mg/dL, respectively.
Patients randomized to rituximab received 1,000 mg on days 1 and 15, followed by another course at 6 months for those who did not achieved a complete remission. The cyclosporine cohort started at 3.5 mg per day divided into two doses for 12 months.
Fervenza's group found that B-cell targeting with rituximab reduced the number of relapses and increased the time to relapse when compared with cyclosporine. After one year of treatment, complete remission was achieved by nine patients on rituximab and three on cyclosporine, with partial remission occurring in 30 patients in both groups. Treatment failed in 25 patients on rituximab compared with 30 on cyclosporine.
Rituximab also had fewer adverse events compared with cyclosporine (23 versus 13), with the latter agent leading to more cases of cardiac disorders, renal and urinary disorders, and vascular disorders.
Disclosures
The trial was funded by Fulk Family Foundation and Genetech/Biogen IDEC.
Primary Source
ASN Kidney Week
Fervenza FC, et al "A multi-center randomized controlled trial of rituximab versus cyclosporine in the treatment of idiopathic membranous nephropathy (MENTOR)" ASN 2017; SA-OR127.