Zhong Zhiqing, Li Hongyan, Zhong Hongzhen, Zhou Tianbiao
Department of Nephrology, The Second Affiliated Hospital, Shantou University Medical College, 515041 Shantou, China,
Department of Nephrology, Huadu District People's Hospital of Guangzhou, Southern Medical University, 510800 Guangzhou, China.
Drug Des Devel Ther. 2019 Mar 11;13:845-856. doi: 10.2147/DDDT.S195113. eCollection 2019.
Long-term treatment programs with low toxicity represent a therapeutic challenge in lupus nephritis (LN). Although a therapeutic benefit of rituximab (RTX) has been reported in LN patients who have failed conventional treatment, the results are controversial. We aimed to assess the clinical efficacy and safety of RTX as a new immunosuppressive medicine in the treatment of LN with a meta-analysis.
Based on predetermined criteria, PubMed, Embase, and Cochrane Library were used to identify the eligible studies. Cochrane Review Manager version 5.3 was applied to pool the data extracted from individual investigations and provide summary effect estimates.
Twenty-four studies with 940 patients were analyzed. In case series trials with specific LN assessment, the complete remission (CR) rate at 12 months was 35.9% (95% CI: 24.2%-49.5%), and total remission (TR: CR plus partial remission) was 73.4% (95% CI: 66.0%-79.7%). In controlled trials, RTX was associated with a higher probability of TR (OR =2.02, 95% CI: 1.23-3.32, <0.01). The CR in the RTX group was higher than that in the control group, although there was no significant difference between the two groups (OR =1.98, 95% CI: 0.90-4.39, >0.05). Additionally, RTX treatment significantly decreased proteinuria (mean difference: -2.79, 95% CI: -3.95 to -1.62, <0.01) as well as the renal activity index in patients with LN (mean difference: -3.46, 95% CI: -4.43 to -2.50, <0.01). In controlled trials, the relative risks of the adverse events of infection and infusion reaction were not notably different between the two groups.
RTX is a promising therapy for the treatment of LN due to significant clinical efficacy and a favorable safety profile. In future studies, larger study populations and longer-term time points may identify additional important patient-centered outcomes.
低毒性的长期治疗方案是狼疮性肾炎（LN）治疗中的一项挑战。尽管有报道称利妥昔单抗（RTX）对常规治疗无效的LN患者有治疗益处，但结果存在争议。我们旨在通过荟萃分析评估RTX作为一种新型免疫抑制药物治疗LN的临床疗效和安全性。
根据预定标准，使用PubMed、Embase和Cochrane图书馆来识别符合条件的研究。应用Cochrane系统评价管理软件5.3汇总从各个研究中提取的数据，并提供汇总效应估计值。
分析了24项研究中的940例患者。在有特定LN评估的病例系列试验中，12个月时的完全缓解（CR）率为35.9%（95%置信区间：24.2%-49.5%），总缓解率（TR：CR加部分缓解）为73.4%（95%置信区间：66.0%-79.7%）。在对照试验中，RTX与更高的TR概率相关（比值比=2.02，95%置信区间：1.23-3.32，P<0.01）。RTX组的CR高于对照组，尽管两组之间无显著差异（比值比=1.98，95%置信区间：0.90-4.39，P>0.05）。此外，RTX治疗显著降低了LN患者的蛋白尿（平均差值：-2.79，9%置信区间：-3.95至-1.62，P<）以及肾脏活动指数（平均差值：-3.46，95%置信区间：-4.43至-2.50，P<0.01）。在对照试验中，两组感染和输液反应不良事件的相对风险无显著差异。
由于显著的临床疗效和良好的安全性，RTX是一种有前景的LN治疗方法。在未来的研究中，更大的研究人群和更长的时间点可能会确定更多以患者为中心的重要结局。
