BLISS-LN
Belimumab in Lupus Nephritis
Patient / Population Intervention / Exposure Comparison Outcome
In 448 patients with active lupus nephritis, adding belimumab to standard therapy increased renal response at week 104 compared with placebo.
N
448
Design
Phase 3 double-blind RCT
Endpoint
Primary efficacy renal response at week 104
Relevance
2
Result43% vs 32%; OR 1.55 (1.04–2.32; p=0.03); renal-related event or death HR 0.51.
Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 10.1056/NEJMoa2001180
Discussion & critique
First biologic approved specifically for lupus nephritis; KDIGO 2024 add-on for active disease.