Journal
KIDNEY INTERNATIONAL
Volume 101, Issue 2, Pages 403-413Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.kint.2021.08.027
Keywords
belimumab; kidney function; lupus nephritis; systemic lupus erythematosus
Categories
Funding
- GlaxoSmithKline (BLISS-LN) [114054]
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Belimumab was found to be most effective in improving kidney response in patients with proliferative lupus nephritis and baseline urine protein/creatinine ratio under 3 g/g. However, it did not show improvement in kidney response in patients with lupus nephritis and sub-epithelial deposits or with a baseline protein/creatinine ratio of 3 g/g or more.
We performed a post hoc analysis of the Belimumab International Study in Lupus Nephritis (BLISS-LN), a Phase 3, multinational, double-blind, 104-week trial, in which 448 patients with lupus nephritis were randomized to receive intravenous belimumab 10 mg/kg or placebo with standard therapy (cyclophosphamide/azathioprine or mycophenolate mofetil). Add-on belimumab was found to be most effective in improving the primary efficacy kidney response and complete kidney response in patients with proliferative lupus nephritis and a baseline urine protein/creatinine ratio under 3 g/g. However, there was no observed improvement in the kidney response with belimumab treatment in patients with lupus nephritis and sub-epithelial deposits or with a baseline protein/creatinine ratio of 3 g/g or more. Belimumab significantly reduced the risk of kidney-related events or death and lupus nephritis flare in the overall population. Belimumab reduced the risk of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) versus standard treatment alone and attenuated the annual rate of eGFR decline in patients who remained on-study. Thus, our data suggest that the addition of belimumab to standard therapy could attenuate the risk of lupus nephritis flare and eGFR decline in a broad spectrum of patients with lupus nephritis.
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