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
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Safety and Efficacy of ONT01 in Lupus
ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.