The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) belimumab (Benlysta) autoinjector for children aged 5 years and older who are diagnosed with systemic lupus erythematosus (SLE).
Belimumab, a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody, is now available for subcutaneous administration at a dose of 200 mg. This marks the first and only at-home treatment in its class for pediatric patients, providing a new level of convenience for children suffering from this chronic autoimmune disease.
Previously, pediatric patients could only receive belimumab through an intravenous formulation. This method required administration by a healthcare professional in a hospital or clinical setting, with a weight-based dose of 10 mg/kg given via a 1-hour infusion every four weeks.
SLE is a chronic inflammatory disease that can affect multiple organs, with the immune system attacking the body’s own tissues. In the United States, between 5,000 and 10,000 children are diagnosed with SLE. Compared to adults, children with SLE often face more severe complications and increased risk of organ damage.
“Lupus tends to be more aggressive and affect children more severely than adults, with those diagnosed in childhood having higher rates of organ damage,” said Mary T. Crimmings, interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, in a press release. “Going to the doctor’s office once every four weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta at home provides much-needed flexibility.”
The safety and efficacy of belimumab were evaluated in a double-blind, placebo-controlled study involving 93 children with SLE over 52 weeks. All participants were on stable SLE regimens, with half having three or more active organ systems at the start of the study, and 19% exhibiting some degree of renal activity, according to the prescribing information.
The primary endpoint of the study was the SLE Responder Index at week 52. Results showed that a higher proportion of pediatric patients receiving belimumab plus standard therapy achieved a treatment response (53%) compared to those receiving placebo plus standard therapy (44%).
Furthermore, pediatric patients treated with belimumab plus standard therapy had a lower risk of experiencing flares (17%) compared to those on placebo plus standard therapy (35%).
Serious and sometimes fatal infections have been reported more frequently among patients receiving belimumab. The most common serious adverse reactions, occurring in less than 5% of patients, included nausea, diarrhea, fever, nasopharyngitis, bronchitis, insomnia, extremity pain, depression, migraine, pharyngitis, and injection site reactions.
“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” said Court Horncastle, senior vice president and head of U.S. specialty at GSK, in the press release. “This approval for an at-home treatment is the first and only of its kind for children with lupus and is a testament to our continued commitment to the lupus community.”
