First Drug OK'd for Lupus Nephritis in Kids

The FDA expanded the approval of belimumab (Benlysta) to include treatment of pediatric patients with active lupus nephritis, drugmaker GSK announced on Wednesday.

Already approved in adults with lupus nephritis, belimumab's new indication is specifically for children 5 to 17 years of age on standard therapy. The BLyS-specific inhibitor is also approved in adults and pediatric patients 5 years and up with active systemic lupus erythematosus (SLE).

Lupus nephritis represents a serious inflammation of the kidneys and can lead to end-stage renal disease and the need for transplant.

"Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus diagnosis," Stevan Gibson, president and CEO of the Lupus Foundation of America, said in a press release from GSK. "This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life."

Belimumab's new label cites a small placebo-controlled trial involving 93 kids with lupus nephritis on standard therapy, which include selective immunosuppressants, corticosteroids, antimalarials, and non-steroidal anti-inflammatory drugs.

In that phase II study, numerically more patients treated with belimumab at a dose of 10 mg/kg every 4 weeks responded to treatment at 1 year -- as assessed by the SLE Responder Index (SRI4) -- versus those receiving placebo (53% vs 44%), though the difference was not significantly different. Serious adverse events (AEs) were more frequent in the placebo arm. Pharmacokinetics and the risk-benefit profile in children were reportedly consistent with studies in adults.

According to GSK, belimumab is a monoclonal antibody that binds to soluble BLyS, but does not bind B cells directly. "By binding BLyS, [belimumab] inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells," the drugmaker explained.

Common AEs observed in trials with belimumab included nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremities, depression, migraine, pharyngitis, and injection site reactions. Serious AEs in adult trials have included serious infections (some fatal), and the drug carries warnings for progressive multifocal leukoencephalopathy, hypersensitivity reactions, and depression and suicidality.

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