Abstract
Off-label use of rituximab is commonly requested for patients with resistant nephropathies. The outcomes and tolerability of rituximab in adult patients with nephropathy treated at our hospital (from 2013 to 2018) were described. Data were retrieved from electronic medical records. Response was classified as complete remission (CR), partial remission (PR), or no response (NR) according to the KDIGO criteria. A total of 89 requests were received for 61 patients. Median age was 58 years (45.9% female). Idiopathic membranous nephropathy (MN) (n = 30) was the most frequent indication, followed by minimal change disease (MCD) (n = 15) and secondary membranoproliferative glomerulonephritis (MPGN) (n = 12). Three patients with focal segmental glomerulosclerosis (FSGS) were included. After most treatment cycles in MN, a CR or PR was observed; median proteinuria levels significantly decreased for these patients (6000 mg/24h (IQR 3584–10,300) vs. 1468.8 (IQR 500–4604.25), p < 0.01). In MPGN, no response was documented after 46.7% of rituximab cycles. A CR or PR was described with the majority of rituximab cycles in MCD, with a significant decrease in proteinuria (6000 mg/24 h (IQR 4007–11,426) vs. 196.8 (IQR 100–1300), p = 0.013). No cycles produced a response in FSGS. Mean CD19+ B-cell decreased in all types of nephropathy (10.44% vs. 0.29%, p < 0.0001). Eleven patients presented infusion-related reactions, and 17 presented infectious complications. The majority of patients with MN and MCD had complete or partial responses; however, neither MPGN nor FSGS had encouraging results.
Highlights
A total of 89 requests for off-label use of rituximab were received for 61 patients during the study period
The results of this study show that the off-label use of rituximab among our patient cohort was mainly for the treatment of idiopathic membranous nephropathy (MN), minimal change disease (MCD), and membranoproliferative glomerulonephritis (MPGN)
As for MCD and focal segmental glomerulosclerosis (FSGS), Hansrivijit et al conducted a systematic review and metaanalysis that included a total of 221 adult patients with MCD or FSGS, and the results indicated that rituximab may be considered as an additional treatment to the standard therapy for these patients [29]
Summary
Rituximab is a chimeric mouse/human monoclonal antibody that binds to the transmembrane antigen CD20 located on B lymphocytes It was initially approved by the European Medicines Agency in 1998 for the treatment of patients with chemoresistant stage III–IV lymphoma. Its indications have broadened, and it is currently authorized for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris. It is often prescribed off-label for the treatment of other indications, such as patients with resistant glomerulonephritis [1]. Despite it being commonly used in clinical practice, the evidence on the efficacy, safety, and tolerability of the off-label use of medicines is often scarce
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