美国FDA于2011年3月9日批准Benlysta (有效成份为belimumab)用于治疗系统性红斑狼疮，主要适用于正在接受常规治疗（用药包括皮质类固醇类、抗疟疾药、免疫抑制剂、非甾体类抗炎药等）的自身抗体阳性患者。Benlysta是56年来FDA批准的首种治疗红斑狼疮新药。 Benlysta通过静脉注射给药直接进入血液，它是有史以来第一种作用于B淋巴细胞刺激因子(BLyS)蛋白的抑制剂，可减少异常的B淋巴细胞的数量，而B淋巴细胞正是引起红斑狼疮的病因。 在此之前，FDA最近一次批准治疗红斑狼疮药物是在1955年，当年批准了Plaquenil (其有效成份为hydroxychloroquine，即羟氯喹)和皮质类固醇。1948年FDA批准阿司匹林治疗红斑狼疮。 红斑狼疮是一种严重的具有在致命性的自身免疫疾病，以女性患者最多，通常在15-44间发病。该病可对身体许多器官造成损害，包括关节、皮肤、肾脏、肺、心脏及大脑，其常见初始症状包括关节肿痛、轻微过敏、发烧、胸痛、头发脱落及倦怠等。 对于美国到底有多少红斑狼疮患者，存在着不同看法，综合各方估计，大概在30万到150万人之间。各种族的人都可能罹患此病，但非洲裔妇女的发病率（新发病例数）比白种女性要高出3倍。 Benlysta的安全性与有效性在两个共有1684名患者参加的临床研究中得到验证。在试验中，患者被随机分成两组，一组使用Benlysta加常规药物治疗，另一组使用安慰剂加常规药物治疗。临床研究排除了先前曾使用过B淋巴细胞刺激因子抑制剂药物及静注环磷酰胺的患者，也不包括那些已经有肾脏及中枢神经系统症状的红斑狼疮病人。 在试验中，使用Benlysta加常规药物治疗的患者其疾病活动性轻于对照组患者。此一结果表明（但并不绝对确定）Benlysta可帮助有些患者减少疾病的严重发作，此外Benlysta还有助于某些病人减少使用类固醇的剂量。 在临床研究中，Benlysta对非洲裔患者及有非洲裔血统的患者似乎无效。因样本数量不够，无法对此作出明确的结论。药品开发商同意就此问题开展进一步的研究。 与安慰剂相比，服用Benlysta的患者出现死亡与严重感染的比例要高些。此外，Benlysta不能与活性疫苗同时使用。FDA要求生产商提供相应指引，将与Benlysta有关的风险告知患者。 在研究中，Benlysta最常见的副作用包括恶心、腹泻和发烧。此外患者静脉注射反应也较常见，可考虑在治疗前服用抗组胺药。 Benlysta由位于美国马里兰州洛克维尔的Human Genome Sciences Inc.公司研制，将由该公司与位于费城的GlaxoSmithKline公司一道在美国市场销售。 Benlysta Benlysta is a human IgG1 λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Benlysta blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells. Benlysta does not bind B cells directly, but by binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. BLyS levels are elevated in patients with SLE and other autoimmune diseases. There is an association between plasma BLyS levels and SLE disease activity. The relative contribution of BLyS levels to the pathophysiology of SLE is not fully understood. Below you will find out more about what it is and how it works. -------------------------------------------------------------------------------- Benlysta Indications Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy. [1] Here you will find out more about the indications for Benlysta. -------------------------------------------------------------------------------- Benlysta Administration This section contains details on the administration of Benlysta including the recommended dosing for adults. -------------------------------------------------------------------------------- Benlysta Efficacy The efficacy of Benlysta has been evaluated in 2 randomised, double-blind, placebo-controlled studies (BLISS-52 and BLISS-76) in 1,684 patients with a clinical diagnosis of SLE. Benlysta 10 mg/kg + Standard of Care (SoC) was proven to provide significantly greater control of disease activity than placebo + SoC, and was generally well tolerated by patients. [1][2][3] Here you will find more information about the benefits of Benlysta. -------------------------------------------------------------------------------- Benlysta Safety The safety of Benlysta in patients with SLE has been evaluated in 3 placebo-controlled studies and was generally well tolerated by patients. The most frequently reported adverse reactions ( >10% of patients treated with Benlysta 10 mg/kg + SoC and at a rate >1% greater than placebo + SoC) were nausea, diarrhoea and pyrexia. [1] Here you will find the key undesirable effects, contraindications, special warnings and precautions for the use of Benlysta. -------------------------------------------------------------------------------- Benlysta Patient Information In this section you will find useful information for patients. -------------------------------------------------------------------------------- Benlysta Links In this section you will find useful links. -------------------------------------------------------------------------------- Benlysta Media and Resources In this section you will find fnformation and audio/visual materials for healthcare professionals and patients, and upcoming lupus events and material from previous events. -------------------------------------------------------------------------------- Benlysta Prescribing Information This is the prescribing information for Benlysta.