A post hoc analysis of BLISS-LN found Belimumab plus mycophenolate mofetil improves kidney outcomes versus placebo plus mycophenolate mofetil in active lupus nephritis.

Comparing belimumab's results from BLISS-LN (phase 3, ClinicalTrials.gov Identifier: NCT01639339) with other LN trial outcomes pose challenges because, unlike other trials, BLISS-LN included patients with pure class V LN (membranous) and patients receiving cyclophosphamide as standard therapy (ST).

将BLISS-LN（第3阶段，ClinicalTrials.gov注册号：NCT01639339）中贝利木单抗的结果与其他LN试验结果进行比较存在挑战，因为与其他试验不同，BLISS-LN包括了纯V类LN（膜性）患者和接受环磷酰胺作为标准治疗（ST）的患者。

This post hoc analysis of BLISS-LN investigated kidney outcomes in patients with proliferative (class III or IV) or proliferative plus membranous LN (class III or IV with/without class V) treated with mycophenolate mofetil (MMF)-based ST to more closely align with those of other phase 3 LN trials and current practice.

这项BLISS-LN的事后分析研究了接受麦考酚酯（MMF）为基础的ST治疗的增殖性（III或IV类）或增殖性加膜性肾小球肾炎（III或IV类，有/无V类）患者的肾脏结果，以更紧密地与其它III期肾小球肾炎试验和当前实践的结果对齐。

Methods

Only patients with active class III or IV LN with/without class V who received MMF ST in BLISS-LN were included.

仅包括在BLISS-LN中接受MMF ST治疗的活动性III或IV类 LN患者，无论是否伴有V类。

Kidney responses (complete renal response [CRR]; primary efficacy renal response [PERR]), urine protein to creatinine ratio (uPCR) under 0.5 g/g responders, estimated glomerular filtration rate (eGFR) slope, and changes from baseline in uPCR, eGFR, and biomarkers were assessed up to Week 104.

评估了肾脏反应（完全肾脏反应[CRR]；主要肾脏疗效反应[PERR]），尿蛋白与肌酐比值(uPCR)低于0.5 g/g的反应者，估算的肾小球滤过率(eGFR)斜率，以及从基线开始的uPCR、eGFR和生物标志物的变化，直至第104周。

Safety outcomes were assessed through Week 104.

安全性结果通过第104周进行评估。

Results

The MMF subgroup comprised 271 patients (60.5% of overall BLISS-LN population; with 135 receiving belimumab; 136 receiving placebo).

MMF亚组包括271名患者（占BLISS-LN总体人群的60.5%；其中135名接受贝利木单抗治疗，136名接受安慰剂治疗）。

Baseline demographics and characteristics were balanced.

基线人口统计学和特征是平衡的。

CRR treatment differences between belimumab and placebo were higher in the MMF subgroup (14.9%) versus the overall BLISS-LN population (10.3%).

与安慰剂相比，贝利木单抗在MMF亚组中的完全肾脏反应（Complete Renal Response, CRR）治疗差异（14.9%）高于BLISS-LN总体人群（10.3%）。

Treatment differences were greater for PERR, uPCR under 0.5 responders and eGFR slope with belimumab versus placebo in the MMF subgroup, and versus the overall population.

在MMF亚组中，与总体人群相比，贝利木单抗与安慰剂相比，部分肾脏反应（Partial Early Response, PERR）、尿蛋白肌酐比（urine protein-to-creatinine ratio, uPCR）小于0.5的反应者和估算肾小球滤过率（estimated Glomerular Filtration Rate, eGFR）斜率的治疗差异更大。

Other endpoints showed a similar trend.

其他终点指标显示出类似的趋势。

Safety outcomes were consistent with belimumab's known safety profile.

安全性结果与贝利木单抗已知的安全性特征一致。

Fewer serious adverse events were reported for belimumab vs placebo in the MMF subgroup.

在使用MMF的亚组中，与安慰剂相比，贝利木单抗报告的严重不良事件较少。

Conclusions

The improvements in kidney outcomes with belimumab in patients with LN receiving MMF highlight the benefit of belimumab in a population more closely aligned with recent phase 3 LN trials and underlines kidney function preservation.

贝利木单抗在使用MMF的狼疮性肾炎患者中改善了肾脏结果，突显了在与近期III期狼疮性肾炎试验更接近的人群中贝利木单抗的益处，并强调了肾脏功能保护的重要性。