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首页> 外文期刊>Drug Design, Development and Therapy >Management of Pediatric Systemic Lupus Erythematosus: Focus on Belimumab
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Management of Pediatric Systemic Lupus Erythematosus: Focus on Belimumab

机译：小儿全身狼疮狼疮的管理：专注于信仰

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摘要

Belimumab (Benlystasup?/sup) 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.
机译：Belimumab（Benlysta ？）是一种完全人源化的单克隆抗体，其抑制B淋巴细胞刺激剂（Blys，也称为肿瘤坏死因子家族的B细胞活化因子），并被美国食品和药物批准管理（FDA）和欧洲药物治疗Autoalibody-阳性系统狼疮红斑狼疮（SLE）的欧洲药物评估机构在具有中等疾病活动的成人中。最近FDA最近被批准用于5至17岁的儿童的FDA。本综述讨论了成人SLE（通过静脉内和皮下管理），在儿科SLE（静脉内给药）中的II期试验和HOC分析中的BELIMEAB期III试验的主要发现。它还评估了在特定的SLE疾病状态下对Belimumab的当前临床试验，并突出了Belimumab的安全性曲线。它讨论了Belimumab在成人和SLE中的临床营销后使用，并结束了我们对使用Belimumab治疗儿科SLE的建议，包括将未来视为未经SLE的儿童使用。

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