FDA approves Benlysta, first treatment for lupus nephritis
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The FDA has approved belimumab in intravenous and subcutaneous formulations for the treatment of lupus nephritis in adult patients who are receiving standard therapy, according to a press release from GlaxoSmithKline.
Previously approved in the United States for the treatment of patients aged 5 years and older with systemic lupus erythematosus, Benlysta (belimumab) is the first therapy authorized to treat lupus nephritis.
“Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease,” Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, said in a press release. “Benlysta is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease.”
The FDA based its approval on results from the BLISS-LN trial, a phase 3, randomized, placebo-controlled, 104-week study. A total of 448 adults with systemic lupus erythematosus and biopsy-confirmed lupus nephritis were randomized 1-to-1 to receive either 10 mg/kg of intravenous belimumab or placebo alongside standard therapy.
According to the study results, 43% of patients who received Benlysta alongside standard therapy achieved Primary Efficacy Renal Response (PERR) at week 104, compared with 32.3% of those in the placebo group (OR = 1.55; 95% CI, 1.04-2.32). Further, more patients in the belimumab achieved key secondary and other efficacy endpoints than those who received a placebo.
“The data from the BLISS-LN study show that Benlysta added to standard therapy not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone,” lead BLISS-LN investigator Richard Furie, MD, of Northwell Health and the Donald and Barbara Zucker School of Medicine at Hofstra–Northwell, said in the release. “Therefore, it is gratifying to see the rewards of decades of research.”
Regarding safety in the BLISS-LN study, 95.5% of patients in the belimumab, and 94.2% of those in the placebo group, demonstrated one or more adverse event, with 25.9% and 29.9% patients, respectively, developing one or more serious adverse event. The discontinuation rate due to adverse events was 12.9% in both groups, with fatal adverse-event rates of 1.8% in the belimumab group and 1.3% in the placebo group. The risk of renal-related event or death was lower among participants who received belimumab compared with those in the placebo group (HR = 0.51; 95% CI, 0.34-0.77).
“Standard-of-care treatment for lupus nephritis has relied upon using strong immunosuppressant drugs and high doses of corticosteroids,” Susan M. Manzi, MD, MPH, medical director of the Lupus Foundation of America, and director of the Lupus Center of Excellence at Allegheny Health Network, said in a press release. “These medications can take a considerable toll on the body. As clinicians, we welcome the option to use Benlysta, which has a favorable safety profile while delivering results with less risk from the side effects associated with legacy lupus nephritis treatments.”
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