2026/05/21 by Richard Furie, Hans‐Joachim Anders, George Bertsias +6 · 1 voice
Medicine · #Renal Diseases and Glomerulopathies #Renal Transplantation Outcomes and Treatments #Systemic Lupus Erythematosus Research
paper · doi:10.1016/j.kint.2026.03.030
openalex publication_date 2026/05/21 · openalex created_date 2026/05/22 · openalex updated_date 2026/07/29
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.