FDA Approves Belimumab Autoinjector for Children With Systemic Lupus Erythematosus

The FDA approved GSK’s belimumab (Benlysta) autoinjector for children 5 years and older with systemic lupus erythematosus (SLE).¹

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The approval is for belimumab, a B-lymphocyte simulator (BLyS)-specific inhibiting monoclonal antibody, to be administered 200 mg subcutaneously. It is the first and only at-home treatment in its class for pediatric patients 5 years and older.

Prior to its approval, children could only receive belimumab through an intravenous formulation, which needed to be administered by a health care professional as a weight-based dose of 10 mg/kg, via a 1-hour infusion in a hospital or clinical setting every 4 weeks.

Lupus is a chronic, multiorgan inflammatory disease that occurs when the immune system attacks its own organs. Between 5000 to 10,000 children in the US are diagnosed with SLE, with children being more likely than adults to experience problems with the vital organs and accrue more 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, Lupus Foundation of America, in a press release.¹ “Going to the doctor’s office once every 4 weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility.”

The safety and efficacy of belimumab was evaluated in a double-blind, placebo-controlled study including 93 children with SLE for 52 weeks. All patients included in the study were on stable regimens for SLE, with 50% of individuals having 3 or more active organ systems involved at baseline, and 19% had some degree of renal activity, according to the prescribing information.²

The primary end point of the study was SLE Responder Index at week 52, in which a higher proportion of pediatric patients who received belimumab plus standard therapy achieved a treatment response (53%) compared with those who received placebo plus standard therapy (44%).

Additionally, pediatric patients who received belimumab plus standard therapy had a lower risk of experiencing flare at 17%, compared with 35% of patients who received placebo plus standard therapy.

Serious and sometimes fatal infections have been reported and occurred more frequently among patients who received belimumab. The most common serious adverse reactions reported in less than 5% of patients included nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reaction.

“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, head of US specialty, GSK, in the press release.¹ “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.”

References
1. FDA approves Benlysta (belimumab) autoinjector for children with systemic lupus erythematosus. News release. GSK. May 20, 2024. Accessed May 23, 2024. https://us.gsk.com/en-us/media/press-releases/fda-approves-benlysta-belimumab-autoinjector-for-children-with-systemic-lupus-erythematosus/

2. Benlysta (belimumab) for injection. Package insert. GSK; 2024. Accessed May 23, 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF