For the first time, children as young as 5 with active lupus nephritis can now receive belimumab treatment at home via a newly approved subcutaneous autoinjector.
The U.S. Food and Drug Administration has approved a 200 mg/mL subcutaneous autoinjector formulation of belimumab (Benlysta) in pediatric patients aged 5 years and older with active lupus nephritis (LN) who are receiving standard therapy. This approval marks the first at-home treatment option in this patient population and expands the use of belimumab, which is already approved for systemic lupus erythematosus (SLE) in pediatric and adult populations.
LN is a serious manifestation of SLE that frequently leads to progressive renal impairment. Pediatric patients often experience more aggressive disease courses than adults; specifically, earlier onset of nephritis and increased risk of long-term organ damage. The new autoinjector formulation provides an alternative to intravenous administration and may help reduce the burden of frequent clinic visits, potentially improving adherence and facilitating continuity of care.
Belimumab is a B-lymphocyte stimulator (BLyS)–specific inhibitor that binds to soluble BLyS to reduce B-cell survival and differentiation into immunoglobulin-producing plasma cells. It does not bind directly to B cells. Belimumab remains the only biologic approved for both SLE and LN, including in children.
The subcutaneous autoinjector is intended for at-home use and may be administered by a health care professional or by a trained caregiver. The formulation will be available immediately for eligible pediatric patients.
Clinicians should remain vigilant for serious risks associated with belimumab, including serious infections, hypersensitivity reactions (including anaphylaxis), progressive multifocal leukoencephalopathy, depression, and increased risk of malignancy. Use in patients with severe active central nervous system lupus is not recommended. The agent is contraindicated in patients with a history of anaphylaxis to belimumab. Live vaccines should not be administered within 30 days of initiating therapy, and concurrent use with other biologic agents, including rituximab, is not supported by safety or efficacy data. Safety findings in pediatric patients were consistent with those observed in adult populations.
Source: GSK
