Benlysta for pediatric lupus nephritis: FDA-approved

Benlysta for children with lupus kidney inflammation (lupus nephritis): FDA-approved on July 26, 2022

This is a monumental breakthrough since children with systemic lupus tend to be sicker than adults. FDA (US Food and Drug Administration) approval of drugs for pediatric diseases is very hard to get.

Background of lupus inflammation (lupus nephritis) in children

Lupus nephritis (kidney inflammation from lupus) is significantly more common in children with SLE than in adults. It is often present at the initial SLE diagnosis or the following year. Proliferative (also known as class III and class IV) lupus nephritis is the most severe form of lupus nephritis.

Over half of children with systemic lupus erythematosus will develop this type of nephritis. Around 10-20% of children may develop kidney failure within 10 years of diagnosis. The risk is highest for class IV nephritis and for those of African American, Asian, and Hispanic ethnicities. Younger children are less likely to develop kidney involvement than adolescents.

Children with lupus nephritis are at higher risk for long-term complications. This includes early-onset strokes, heart attacks, and infections. They may need higher doses of steroids for long periods, increasing the risk of osteoporosis (which can cause broken bones), avascular necrosis (where a piece of bone can die), and adrenal insufficiency.

NOTE: The last 3 paragraphs come from the manuscript for “The Lupus Encyclopedia” 2nd edition, currently under review by Johns Hopkins University Press.

What does this add to the treatment of children with lupus nephritis (kidney inflammation)?

• The FDA also approved belimumab (Benlysta) as the first drug approved to treat adults with lupus nephritis in December 2020.
• There are no other drugs approved by the FDA for use in children with lupus nephritis.
• Since dialysis and kidney transplantation due to kidney failure are not uncommon in pediatric lupus nephritis, it is essential we have better therapies. Brad Rovin, MD (at Ohio State University) et al recently showed that adults on Benlysta have less kidney function decline over time compared to patients receiving older lupus nephritis treatment regimens that did not include Benlysta. If this holds true in children, it is possible to decrease their risk for these bad outcomes.
• Benlysta was shown to be safe and effective in children with systemic lupus.

Dosing and other information about Benlysta for pediatric lupus nephritis

• The dose is the same as for pediatric systemic lupus and for adults with systemic lupus and lupus nephritis who receive the intravenous form
• 10 mg/kg given every two weeks for 3 infusions followed by every 4 weeks after that