What the trial was testing
The BLISS-LN enrolled 448 patients with lupus nephritis. The study was sponsored by GlaxoSmithKline and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
43% reached the kidney response goal at two years vs. 32% on standard care alone.
New England Journal of Medicine · 2020 · NCT01639339
These findings — that kidney response rate at two years on belimumab plus standard therapy vs. standard therapy alone — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 448 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with lupus nephritis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Belimumab (Benlysta) is FDA-approved for lupus nephritis and available now. It is given alongside standard therapy like mycophenolate or cyclophosphamide. Most common side effects are infections and infusion reactions. Ask a rheumatologist or kidney specialist if it fits your treatment plan.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open lupus nephritis trials
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.
Dapagliflozin in Active Lupus Nephritis
Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.