Kidney international · 2026
A post hoc analysis of BLISS-LN found Belimumab plus mycophenolate mofetil improves kidney outcomes versus placebo plus mycophenolate mofetil in active lupus nephritis.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Furie Richard, Anders Hans-Joachim, Bertsias George, Delgado Ana, Levy Roger A, Curtis Paula, O'Shea Ciara, Tomlinson Ryan, Rovin Brad
Аннотация
INTRODUCTION: Belimumab, approved for systemic lupus erythematosus (SLE) and lupus nephritis (LN) treatment, is a B-cell-modulating monoclonal antibody that selectively inhibits B-lymphocyte stimulator (BLyS) and downregulates autoreactive B-cells. Comparing belimumab's results from BLISS-LN (phase 3, ClinicalTrials.gov Identifier: NCT01639339) with other LN trial outcomes pose challenges because, unlike other trials, BLISS-LN included patients with pure class V LN (membranous) and patients receiving cyclophosphamide as standard therapy (ST). This post hoc analysis of BLISS-LN investigated kidney outcomes in patients with proliferative (class III or IV) or proliferative plus membranous LN (class III or IV with/without class V) treated with mycophenolate mofetil (MMF)-based ST to more closely align with those of other phase 3 LN trials and current practice.
METHODS: Only patients with active class III or IV LN with/without class V who received MMF ST in BLISS-LN were included. Kidney responses (complete renal response [CRR]; primary efficacy renal response [PERR]), urine protein to creatinine ratio (uPCR) under 0.5 g/g responders, estimated glomerular filtration rate (eGFR) slope, and changes from baseline in uPCR, eGFR, and biomarkers were assessed up to Week 104. Safety outcomes were assessed through Week 104.
RESULTS: The MMF subgroup comprised 271 patients (60.5% of overall BLISS-LN population; with 135 receiving belimumab; 136 receiving placebo). Baseline demographics and characteristics were balanced. CRR treatment differences between belimumab and placebo were higher in the MMF subgroup (14.9%) versus the overall BLISS-LN population (10.3%). Treatment differences were greater for PERR, uPCR under 0.5 responders and eGFR slope with belimumab versus placebo in the MMF subgroup, and versus the overall population. Other endpoints showed a similar trend. Safety outcomes were consistent with belimumab's known safety profile. Fewer serious adverse events were reported for belimumab vs placebo in the MMF subgroup.
CONCLUSIONS: The improvements in kidney outcomes with belimumab in patients with LN receiving MMF highlight the benefit of belimumab in a population more closely aligned with recent phase 3 LN trials and underlines kidney function preservation.
METHODS: Only patients with active class III or IV LN with/without class V who received MMF ST in BLISS-LN were included. Kidney responses (complete renal response [CRR]; primary efficacy renal response [PERR]), urine protein to creatinine ratio (uPCR) under 0.5 g/g responders, estimated glomerular filtration rate (eGFR) slope, and changes from baseline in uPCR, eGFR, and biomarkers were assessed up to Week 104. Safety outcomes were assessed through Week 104.
RESULTS: The MMF subgroup comprised 271 patients (60.5% of overall BLISS-LN population; with 135 receiving belimumab; 136 receiving placebo). Baseline demographics and characteristics were balanced. CRR treatment differences between belimumab and placebo were higher in the MMF subgroup (14.9%) versus the overall BLISS-LN population (10.3%). Treatment differences were greater for PERR, uPCR under 0.5 responders and eGFR slope with belimumab versus placebo in the MMF subgroup, and versus the overall population. Other endpoints showed a similar trend. Safety outcomes were consistent with belimumab's known safety profile. Fewer serious adverse events were reported for belimumab vs placebo in the MMF subgroup.
CONCLUSIONS: The improvements in kidney outcomes with belimumab in patients with LN receiving MMF highlight the benefit of belimumab in a population more closely aligned with recent phase 3 LN trials and underlines kidney function preservation.