Management of Pediatric Systemic Lupus Erythematosus: Focus on Belimumab

Abstract

Belimumab (Benlysta^®) is a fully humanized monoclonal antibody that inhibits B lymphocyte stimulator (BLyS, also known as B cell-activating factor of the tumor necrosis factor family) and was approved by the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in adults with moderate disease activity. Belimumab was recently FDA approved for use in children with SLE between 5 and 17 years of age. This review discusses the key findings of the belimumab phase III trials in adult SLE (via intravenous and subcutaneous administrations), phase II trial in pediatric SLE (intravenous administration), and post hoc analyses. It also evaluates the current clinical trials of belimumab in specific SLE disease states and highlights the safety profile of belimumab. It discusses the clinical post-marketing use of belimumab in adults and children with SLE and concludes with our recommendations for the use of belimumab to treat pediatric SLE, including a look to the future with increased real-world use in children with SLE.

Keywords:

• belimumab
• pediatric SLE
• lupus treatment

Acknowledgments

The authors thank Dr. B Anne Eberhard for her critical comments.

Abbreviations

ACR, American College of Rheumatology; AE, adverse event; BAFF, B-cell activating factor; BILAG, British Isles Lupus Assessment Group; BLyS, B cell lymphocyte stimulator; CALIBRATE, Rituximab and belimumab for lupus nephritis; CNS, central nervous system; cSLE, childhood-onset systemic lupus erythematosus; dsDNA, double-stranded DNA; EMBRACE, Efficacy and safety of belimumab in Black race patients with systemic lupus erythematosus (SLE); EMEA, European Medicines Evaluation Agency; GFR, glomerular filtration rate; IV, intravenous; FDA, Food and Drug Administration; LN, lupus nephritis; NPSLE, neuropsychiatric lupus; PLUTO, Pediatric lupus trial of belimumab plus background standard therapy; PRINTO, Paediatric rheumatology international trials organisation; PML, progressive multifocal leukoencephalopathy; PGA, physician global assessment; SAE, serious adverse event; SELENA-SLEDAI, The Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SC, subcutaneous; SOC, standard of care; SRI, SLE responder index.

Disclosure

The authors report no conflicts of interest in this work.