Benlysta (belimumab) Indication Expanded to Children with Systemic Lupus Erythematosus (SLE)

The FDA has approved Benlysta for use in children with systemic lupus erythematosus (SLE), making it the first drug approved for pediatric SLE. Approved in adults in 2011, Benlysta (belimumab, GSK) is a B-lymphocyte stimulator (BLyS) specific inhibitor that was originally indicated for treatment of adult patients with active, autoantibody-positive, SLE who are receiving a standard therapy. 

This is the first treatment approved for pediatric patients with SLE. Currently, belimumab is only approved for IV administration in children. It is approved as a subcutaneous administration in adults. 

When given as an IV, the dosage is 10 mg/kg of belimumab administered at two-week intervals for the first three doses, followed by four-week intervals thereafter.  

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Belimumab prescribing information also suggests administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. It is contraindicated in patients who have experienced previous anaphylaxis to belimumab. The drug has also not been studied in combination with other biologicals or intravenous cyclophosphamide. 

According to the CDC, SLE is relatively uncommon, but is the most common form of lupus. The FDA reports that childhood onset of SLE is rare; however, when it does occur, it is often more active than in adult patients. Children with SLE are at risk for developing increased organ damage and complications, as well as adverse events from the life-long treatments usually required.

Pediatric treatment with belimumab for SLE was studied more than 52 weeks in 93 patients, according to the FDA. Those patients who received belimumab plus standard therapy were at a lower risk and frequency of a severe flare.

The most common side effects reported included nausea, diarrhea, and fever. The prescribing information includes a warning for mortality, serious infections, hypersensitivity and depression, based on data from clinical studies in adults with SLE. The drug should not be administered with live vaccines.

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