Drug Design, Development and Therapy (Jun 2020)
Management of Pediatric Systemic Lupus Erythematosus: Focus on Belimumab
Abstract
Marla Guzman,1,2 Joyce S Hui-Yuen1– 3 1Division of Pediatric Rheumatology, Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, NY, USA; 2Department of Pediatrics, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; 3Center for Autoimmune, Musculoskeletal, and Hematopoietic Diseases Research, Feinstein Institute for Medical Research, Manhasset, NY, USACorrespondence: Joyce S Hui-YuenDivision of Pediatric Rheumatology, Steven and Alexandra Cohen Children’s Medical Center, 1991 Marcus Avenue, Suite M100, New Hyde Park, NY 11040 Tel +1 516 472 3700Fax +1 516 472 3752Email [email protected]: 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
