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Phase 3 Clinical Trial of Belimumab for Lupus Nephritis Reports Positive Results

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Northwell Health’s Division of Rheumatology and the Feinstein Institutes for Medical Research announced today the results from the largest Phase 3 lupus nephritis clinical trial ever conducted. The study, known as the BLISS-LN trial, found positive results of the efficacy and safety of the drug belimumab in patients with active lupus nephritis, a condition that causes inflammation in the kidneys of patients with systemic lupus erythematosus (SLE).

The groundbreaking results could lead to belimumab becoming the first drug approved by the Food and Drug Administration (FDA) to treat lupus nephritis, the most common severe complication of SLE that could lead to end-stage kidney disease.

The landmark study, led by Richard Furie, MD, chief of the Division of Rheumatology at Northwell Health, published results in the New England Journal of Medicine. The trial was conducted at 107 sites in 21 countries and included 448 randomized patients with biopsy-proven, active lupus nephritis. The participants were given 10 mg/kg intravenous belimumab or placebo in addition to standard therapy for lupus nephritis. Overall, at week 104 a significant number of patients (43 percent) achieved the primary goal of Primary Efficacy Renal Response (PERR) – a composite measure of kidney response. Additionally, belimumab reduced the risk of worsening kidney function during the study by almost 50 percent, compared with standard therapy alone.

“This history-making clinical trial is the first successful study after decades of attempts with other lupus nephritis therapies," said Dr. Furie, professor at the Feinstein Institutes and professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “This trial will hopefully lead to the FDA's approval to extend belimumab’s use to lupus nephritis, which represents the greatest unmet need for patients with SLE.”

In patients with SLE, the immune system attacks the body’s tissues, causing widespread inflammation and damage to the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. There is no cure for lupus, but it can be treated with medical interventions and lifestyle changes. Lupus nephritis occurs in 25 to 60 percent of SLE patients and contributes to increased morbidity and mortality. Ten to 30 percent of lupus nephritis patients progress to end-stage kidney disease, and that rate has remained unchanged in the past three decades.

“Kidney failure is a major complication of systemic lupus erythematosus, and previously difficult to treat,” Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. “Under Dr. Furie’s leadership, this clinical trial may provide a new therapeutic option for those patients most in need.”

Reference: Furie R, Rovin BH, Houssiau H, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med 2020;383:1117-1128 doi:10.1056/NEJMoa2001180

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