Abstract
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.
Highlights
Lupus nephritis (LN) is one of the most severe organ manifestations of systemic lupus erythematosus.[1]
BLISS-LN demonstrated that adding belimumab to standard therapies (STs) significantly improved kidney responses (PERR and complete renal response (CRR)) compared with ST alone, but did not increase adverse events.[9]
We performed a post hoc analysis of BLISS-LN and found that the risk of an LN flare over time decreased in patients given ST plus belimumab versus ST alone
Summary
Lupus nephritis (LN) is one of the most severe organ manifestations of systemic lupus erythematosus.[1]. In addition to BLISS-LN, other novel therapies are being evaluated for LN treatment Despite these latest positive advances, the question remains how effective the emerging therapies will be in different subpopulations of patients with LN and in preserving long-term kidney function. Given the considerable number of patients who progress to ESKD,[7,10] this is a important concern To investigate this question for belimumab, secondary and exploratory analyses of BLISS-LN were performed, focusing on primary and secondary efficacy end points in different subgroups and on other kidney outcomes directly relevant to long-term kidney health and survival. The results of these analyses are reported here
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