Belimumab with rituximab for the treatment of primary membranous nephropathy
- 1Immune Tolerance Network
Abstract
IntroductionB cell depletion with rituximab leads to complete or partial remission (CR/PR) in only [~]60% of patients with primary membranous nephropathy (PMN). Adding belimumab to rituximab may result in greater depletion of memory B cells, limit the re-emergence of autoreactive B cells, and improve clinical responses.
MethodsREBOOT Part A (NCT03949855) is a single arm, open-label, pharmacokinetic study where all participants had proteinuria [≥] 4g/day and detectable serum anti-phospholipase A2 receptor (anti-PLA2R) antibodies. Participants received belimumab 200 mg subcutaneously weekly for 52 weeks and rituximab 1000 mg intravenously at weeks 4 and 6. Assessments included belimumab exposure at week 4 and CR/PR at week 104.
ResultsSeventeen participants started belimumab. Belimumab exposure was not significantly reduced in those with high (>8 g/day) proteinuria at week 4. Among all treated participants, 59% (10/17) achieved CR/PR at week 104, while in per protocol analyses, 91% (10/11) achieved CR/PR at week 104. All participants in per protocol analyses had normal serum albumin and undetectable serum anti-PLA2R by week 104. Circulating memory B cells increased before rituximab and were depleted by rituximab. B cell re-constitution occurred after week 52 with primarily naive and transitional B cells. Belimumab with rituximab was well-tolerated, with one participant discontinuing belimumab due to infection.
ConclusionIn this study, a high proportion of participants receiving belimumab with rituximab achieved CR/PR. Thus, a multi-targeted approach to B cell depletion may improve immunologic and clinical outcomes in PMN and is being studied in a larger, randomized, placebo-controlled clinical trial.
Versions
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BibTeX
@misc{chung2026belimumab,
title = {{Belimumab with rituximab for the treatment of primary membranous nephropathy}},
author = {S. A. Chung and L. Stelzig and M. A. Sherman and W. Gao and P. Tosta and L. A. Cooney and S. Adler and N. Aslam and I. Ayoub and A. S. Bomback and G. Coppock and V. K. Derebail and F. Kamal and D. V. Rizk and K. R. Tuttle and M. Waldman and W. T. Barry and P. H. Nachman},
howpublished = {medRxiv},
year = {2026},
month = aug,
doi = {10.64898/2026.08.26.26360913},
url = {https://www.medrxiv.org/content/10.64898/2026.08.26.26360913v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Belimumab with rituximab for the treatment of primary membranous nephropathy
AU - S. A. Chung
AU - L. Stelzig
AU - M. A. Sherman
AU - W. Gao
AU - P. Tosta
AU - L. A. Cooney
AU - S. Adler
AU - N. Aslam
AU - I. Ayoub
AU - A. S. Bomback
AU - G. Coppock
AU - V. K. Derebail
AU - F. Kamal
AU - D. V. Rizk
AU - K. R. Tuttle
AU - M. Waldman
AU - W. T. Barry
AU - P. H. Nachman
PY - 2026
DA - 2026/08/26
PB - medRxiv
DO - 10.64898/2026.08.26.26360913
UR - https://www.medrxiv.org/content/10.64898/2026.08.26.26360913v1
AB - IntroductionB cell depletion with rituximab leads to complete or partial remission (CR/PR) in only [~]60% of patients with primary membranous nephropathy (PMN). Adding belimumab to rituximab may result in greater depletion of memory B cells, limit the re-emergence of autoreactive B cells, and improve clinical responses. MethodsREBOOT Part A (NCT03949855) is a single arm, open-label, pharmacokinetic study where all participants had proteinuria [≥] 4g/day and detectable serum anti-phospholipase A2 receptor (anti-PLA2R) antibodies. Participants received belimumab 200 mg subcutaneously weekly for 52 weeks and rituximab 1000 mg intravenously at weeks 4 and 6. Assessments included belimumab exposure at week 4 and CR/PR at week 104. ResultsSeventeen participants started belimumab. Belimumab exposure was not significantly reduced in those with high (>8 g/day) proteinuria at week 4. Among all treated participants, 59% (10/17) achieved CR/PR at week 104, while in per protocol analyses, 91% (10/11) achieved CR/PR at week 104. All participants in per protocol analyses had normal serum albumin and undetectable serum anti-PLA2R by week 104. Circulating memory B cells increased before rituximab and were depleted by rituximab. B cell re-constitution occurred after week 52 with primarily naive and transitional B cells. Belimumab with rituximab was well-tolerated, with one participant discontinuing belimumab due to infection. ConclusionIn this study, a high proportion of participants receiving belimumab with rituximab achieved CR/PR. Thus, a multi-targeted approach to B cell depletion may improve immunologic and clinical outcomes in PMN and is being studied in a larger, randomized, placebo-controlled clinical trial.
ER -