Belimumab + MMF in patients with LN: BLISS-LN trial post hoc analysis

Results from a post hoc analysis of the randomized, placebo-controlled, phase III BLISS-LN trial (NCT01639339) were published in Kidney International by Furie et al. The study investigated kidney outcomes with belimumab vs placebo in 272 patients with proliferative (Class III or IV) or proliferative plus membranous (Class III or IV with/without Class V) lupus nephritis (LN) who received mycophenolate mofetil (MMF) as standard therapy. The primary outcome was complete renal response (CRR) at Week 104.

Key data: At Week 104, CRR was achieved by 32.6% vs 17.6% of patients receiving belimumab vs placebo (odds ratio [OR], 2.22; 95% confidence interval [CI], 1.23–3.99), regardless of baseline estimated glomerular filtration rate (eGFR). The primary efficacy renal response (PERR) rates (46.7% vs 31.6%; OR, 1.79; 95% CI, 1.07–2.99), proportion of urine protein/creatinine ratio (uPCR) <0.5 g/g responders (41.5% vs 26.5%; OR, 1.84; 95% CI, 1.09–3.12), and mean change from baseline in eGFR (10.8 mL/min/1.73m² vs 3.7 mL/min/1.73m²) were greater in the belimumab vs placebo group. The incidence of adverse events (AEs) was similar between the belimumab and placebo groups, though fewer serious AEs (SAEs) were reported with belimumab vs placebo (23.7% vs 32.8%).

Key learning: Belimumab provides greater kidney outcome benefits and a favorable safety profile compared with placebo in patients with Class III or IV (±V) LN receiving MMF-based standard therapy, supporting the use of belimumab in this patient population. Further, this combination reflects current guidelines for LN, which recommend early use of an advanced therapy alongside glucocorticoids and immunosuppressants.