FDA Approves Subcutaneous Belimumab for Patients Aged 5 With Systemic Lupus Erythematosus


Belimumab (Benlysta; GSK) is a B-lymphocyte stimulator-specific inhibiting monoclonal antibody.

The FDA approved belimumab (Benlysta; GSK) as a 200 mg subcutaneous injection for patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving current therapy. With this approval, pediatric patients can now receive treatment at home.1

antibodies contribute to brain pathology associated with autoimmune diseases such as systemic lupus erythematosus | Image Credit: Love Employee - stock.adobe.com

Image Credit: Love Employee - stock.adobe.com

“Lupus tends to be more aggressive and affect children more severely than adults, with those diagnosed in childhood having higher rates of organ damage. 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 [belimumab] in the comfort of their home provides much-needed flexibility," Mary T. Crimmings, interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, said in a press release.1

According to the press release, children aged 5 and older could previously only receive the drug through an intravenous formulation administered by health care professionals. This would take place in a clinical setting every 4 weeks for approximately 1 hour. With the new approval, a patient’s caregiver could administer the medication at home with an autoinjector once a week for children who weigh 40 kg or more, or once every 2 weeks for children who weigh 15 kg to <40 kg.1

The safety and efficacy of the drug was evaluated in a double-blind, placebo-controlled study including 93 pediatric patients with SLE for 52 weeks. All patients included were on stable regiments for SLE with a median age of 15 and 95% were female. Furthermore, 50% of individuals had 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 endpoint of the study was SLE Responder Index at week 52. Investigators found that a higher proportion of pediatric individuals achieved a response for patients receiving belimumab and the standard therapy at 53% compared to the standard therapy alone at 44%.2

Furthermore, in the 3 components of SLE Responder Index, those receiving belimumab achieved higher scores at 55%, 74%, and 76% for percentage of patients with reduction in Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) ≥4, no worsening by British Isles Lupus Assessment Group (BILAG) index, and no worsening by Physician Global Assessment (PGA), respectively, compared to 44%, 62%, and 67%, respectively, with the placebo.2

Patients receiving belimumab also had higher scores in the other endpoints of SLE Responder Index-6 using SELENA-SLEDAI ≥6-point reduction at 41% and proportion of patients with a sustained SLE Responder Index at 43% compared to 34% and 41%, respectively, for those receiving the placebo.2

Additionally, at baseline 95% of patients were receiving prednisone, and among those, 20% who received belimumab reduced their average usage by at least 25% per day during weeks 44 through 52 compared to 21% of those on only the standard of care and placebo. Furthermore, the proportion of pediatric patients that reported at least 1 flare up was lower with belimumab at 17% compared to 35% for those receiving the placebo and standard of care. Of those who received a severe flare up, the median time to first flareup was 150 days for belimumab and 113 days for those receiving the standard of care alone.2

Common adverse events include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reaction.2

The use of belimumab SC has not been evaluated for individuals with severe active central nervous system lupus.2


  1. FDA approves Benlysta (belimumab) autoinjector for children with systemic lupus erythematosus. News release. GSK. May 20, 2024. Accessed May 20, 2024. https://us.gsk.com/en-us/media/press-releases/fda-approves-benlysta-belimumab-autoinjector-for-children-with-systemic-lupus-erythematosus/
  2. GSK. Benlysta (belimumab) for injection [package insert]. US Food and Drug Administration. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF. Revised May 2024. Accessed May 20, 2024.
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