The Feinstein Institutes for Medical Research and Northwell Health’s Division of Rheumatology in the US have announced improved renal response with belimumab in a Phase III clinical trial for lupus nephritis.
Lupus nephritis is termed as a disorder characterised by inflammation in the kidneys of systemic lupus erythematosus (SLE) patients.
According to the study data published in the New England Journal of Medicine, belimumab could become the first US Food and Drug Administration (FDA)-approved drug to treat lupus nephritis.
Named BLISS-LN trial, the study assessed the safety and efficacy of belimumab in 448 patients with biopsy-proven active lupus nephritis at 107 sites across 21 countries.
GlaxoSmithKline (GSK) funded the trial, where participants were administered intravenous belimumab or placebo at a dose of 10mg/kg along with standard therapy.
Overall, 43% of patients reached the primary objective of primary efficacy renal response at week 104.
The study showed that belimumab mitigated the risk of worsening kidney function by nearly 50% versus standard therapy alone.
Northwell Health Rheumatology division chief and study lead Richard Furie said: “This history-making clinical trial is the first successful study after decades of attempts with other lupus nephritis therapies.
“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 SLE patients, the immune system attacks the body’s tissues, leading to inflammation and damage to the affected organs. It can potentially affect the joints, skin, brain, lungs, kidneys and blood vessels.
About 25% to 60% of SLE patients are detected with lupus nephritis, which is related to high morbidity and mortality.
In March this year, the Feinstein Institutes for Medical Research at Northwell Health collaborated with Gilead Sciences, Regeneron Pharmaceuticals and Sanofi to study potential treatments for Covid-19.