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Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis

Open access
Furie, Richard, Rovin, Brad H., Houssiau, Frédéric, Malvar, Ana, Teng, Y.K. Onno, Contreras, Gabriel, Amoura, Zahir, Yu, Xueqing, Mok, Chi-Chiu, Santiago, Mittermayer B., Saxena, Amit, Green, Yulia, Ji, Beulah, Kleoudis, Christi, Burriss, Susan W., Barnett, Carly, Roth, David A.·2020·New England Journal of Medicine

Abstract

BACKGROUND: In adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine), are unknown. METHODS: , and no use of rescue therapy). The time to a renal-related event or death was assessed. RESULTS: A total of 448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group). At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02). The risk of a renal-related event or death was lower among patients who received belimumab than among those who received placebo (hazard ratio, 0.51; 95% CI, 0.34 to 0.77; P = 0.001). The safety profile of belimumab was consistent with that in previous trials. CONCLUSIONS: In this trial involving patients with active lupus nephritis, more patients who received belimumab plus standard therapy had a primary efficacy renal response than those who received standard therapy alone. (Funded by GlaxoSmithKline; BLISS-LN ClinicalTrials.gov number, NCT01639339.).

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Metadata

Authors
Furie, R., Rovin, B. H., Houssiau, F., Malvar, A., Teng, Y. K. O., Contreras, G., Amoura, Z., Yu, X., Mok, C.-C., Santiago, M. B., Saxena, A., Green, Y., Ji, B., Kleoudis, C., Burriss, S. W., Barnett, C., & Roth, D. A.
Venue
New England Journal of Medicine
Published
2020-09-17
Volume
383
Issue
12
Pages
1117-1128
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3085025551
Cited by
1,032
References
2
FWCI
81.52
Type
journal article
Language
en
Open access
bronze
Funders
GSK (GSK Study 114054)

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CoChat. (2026). Citation check: Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. https://app.cochat.ai/papers/10.1056/nejmoa2001180
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Furie, R., Rovin, B. H., Houssiau, F., Malvar, A., Teng, Y. K. O., Contreras, G., Amoura, Z., Yu, X., Mok, C.-C., Santiago, M. B., Saxena, A., Green, Y., Ji, B., Kleoudis, C., Burriss, S. W., Barnett, C., & Roth, D. A. (2020). Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2001180

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.