Guerreiro Castro Sara, Isenberg David A
Autoimmune Diseases Unit, Internal Medicine 7.2 Dept, Hospital Curry Cabral, Centro Hospitalar Lisboa Central, Lisbon, Portugal.
Centre for Rheumatology, University College London, Room 424, 4th Floor Rayne Building, 5 University Street, London WC1E 6JF, UK.
Ther Adv Musculoskelet Dis. 2017 Mar;9(3):75-85. doi: 10.1177/1759720X17690474. Epub 2017 Mar 1.
Systemic lupus erythematosus (SLE) is a complex autoimmune rheumatic disease with multiple presentations, whose management presents many challenges. Many disease modifying or immunosuppressive drugs have been used with limited success, especially in patients with more severe disease activity. Belimumab is the first drug to be approved specifically for the treatment of SLE in more than 50 years. By blocking the B-cell activating factor, it interferes in B-cell differentiation and survival. Here we consider the results of the clinical trials that led to its approval, as well as the post-hoc analyses, follow-up studies and the current trials.
系统性红斑狼疮（SLE）是一种具有多种表现形式的复杂自身免疫性风湿疾病，其治疗面临诸多挑战。许多改善病情或免疫抑制药物的使用效果有限，尤其是在疾病活动较为严重的患者中。贝利尤单抗是50多年来首个被专门批准用于治疗SLE的药物。通过阻断B细胞活化因子，它可干扰B细胞的分化和存活。在此，我们探讨了促成其获批的临床试验结果，以及事后分析、随访研究和当前的试验情况。
