ABSTRACT

Introduction: Systemic Lupus Erythematosus (SLE) is a chronic B cell-mediated autoimmune disease which can potentially involve several organs and systems. The development of SLE is associated with a complexity of genetic, hormonal and environmental factors leading to immune deregulation and production of autoantibodies. Therefore, novel therapies have focused on B cells as key effectors of SLE pathogenesis. Belimumab is a fully humanized monoclonal antibody that antagonizes B-lymphocyte stimulator (BLyS); it is the first and the only biological drug approved for SLE in over 50 years.

Areas covered: In this review we discuss the pharmacological properties of belimumab, new recommendations for its use in clinical practice and its evidence of efficacy and safety based on clinical trial and real-life data.

Expert opinion: Efficacy and safety of belimumab in clinical practice have been well established. To date, it is known that early introduction of belimumab in SLE can maximize the efficacy of the drug. A number of questions are still open, such as the timing of belimumab discontinuation and its possible association with other biological drugs, which need to be assessed in future studies.

摘要

简介：系统性红斑狼疮 (SLE) 是一种慢性 B 细胞介导的自身免疫性疾病，可能涉及多个器官和系统。SLE 的发展与导致免疫失调和自身抗体产生的遗传、激素和环境因素的复杂性有关。因此，新疗法将 B 细胞作为 SLE 发病机制的关键效应物。贝利木单抗是一种完全人源化的单克隆抗体，可拮抗 B 淋巴细胞刺激物 (BLyS)；它是 50 多年来第一个也是唯一一个获批用于 SLE 的生物药物。

涵盖的领域：在这篇综述中，我们讨论了贝利木单抗的药理学特性、其在临床实践中的新推荐及其基于临床试验和真实数据的有效性和安全性证据。

专家意见：贝利木单抗在临床实践中的有效性和安全性已得到充分确立。迄今为止，众所周知，在 SLE 中早期引入贝利木单抗可以最大限度地提高药物的疗效。许多问题仍然悬而未决，例如贝利木单抗停药的时间及其与其他生物药物的可能关联，需要在未来的研究中进行评估。