贝里穆马布
医学
狼疮性肾炎
析因分析
蛋白尿
内科学
系统性红斑狼疮
安慰剂
临床试验
免疫学
疾病
肾
病理
抗体
B细胞激活因子
替代医学
B细胞
作者
MA Dooley,Frédéric Houssiau,Cynthia Aranow,D. D’Cruz,Anca Askanase,DA Roth,Z. John Zhong,Simon Cooper,WW Freimuth,EM Ginzler
出处
期刊:Lupus
[SAGE]
日期:2012-12-21
卷期号:22 (1): 63-72
被引量:255
标识
DOI:10.1177/0961203312465781
摘要
A pooled post-hoc analysis of the phase 3, randomized, placebo-controlled BLISS trials (1684 patients with active systemic lupus erythematosus (SLE)) was performed to evaluate the effect of belimumab on renal parameters in patients with renal involvement at baseline, and to explore whether belimumab offered additional renal benefit to patients receiving mycophenolate mofetil at baseline. In addition to belimumab or placebo, all patients received standard SLE therapy. Patients with severe active lupus nephritis were excluded from the trials. Over 52 weeks, rates of renal flare, renal remission, renal organ disease improvement (assessed by Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index and British Isles Lupus Assessment Group), proteinuria reduction, grade 3/4 proteinuria, and serologic activity favored belimumab, although the between-group differences in most renal outcomes were not significant. Among the 267 patients with renal involvement at baseline, those receiving mycophenolate mofetil or with serologic activity at baseline had greater renal organ disease improvement with belimumab than with placebo. Limitations of this analysis included the small patient numbers and the post-hoc nature of this pooled analysis. The results suggest that belimumab may offer renal benefit in patients with SLE. Further study is warranted in patients with severe active lupus nephritis.
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