在真实环境中（BeRLiSS-LN），添加贝利木单抗治疗狼疮性肾炎患者具有持久的肾脏应答和安全性。来自一个大型的、全国性的、多中心队列的结果。
Durable renal response and safety with add-on belimumab in patients with lupus nephritis in real-life setting (BeRLiSS-LN). Results from a large, nationwide, multicentric cohort.
机构信息
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
出版信息
J Autoimmun. 2021 Nov;124:102729. doi: 10.1016/j.jaut.2021.102729. Epub 2021 Sep 30.
BACKGROUND
Belimumab was recently approved for treatment of lupus glomerulonephritis (LN).
AIM
To evaluate renal response and its predictors in LN patients receiving belimumab in real-life.
PATIENTS AND METHODS
We considered all patients fulfilling the SLEDAI-2K renal items and/or having estimated glomerular filtration rate (eGFR)≤60 ml/min/1.73 m, with positive anti-dsDNA and/or low C3/C4 enrolled in the multicentre Italian lupus cohort BeRLiSS (BElimumab in Real LIfe Setting Study), treated with monthly IV Belimumab 10 mg/kg over standard treatment. Primary efficacy renal response (PERR), defined as proteinuria ≤0.7 g/24 h, eGFR≥60 ml/min/1.73 m without rescue therapy, was considered as primary outcome. Complete renal response (CRR; proteinuria <0.5 g/24 h, eGFR≥90 ml/min/1.73 m) was considered as secondary outcome. Prevalence and predictors of PERR were evaluated at 6, 12, 24 months by multivariate logistic regression.
RESULTS
Among the 466 SLE patients of BeRLiSS, 91 fulfilled the inclusion criteria, 79 females, median age 41.0 (33.0-47.0) years, median follow-up 22.0 (12.0-36.0) months. Sixty-four (70.3%) achieved PERR, of whom 38.4% reached CRR. Among patients achieving PERR at 6 months, 86.7% maintained response throughout the follow-up. At multivariable analysis, hypertension (OR [95%CI]: 0.28 [0.09-0.89], p = 0.032), high baseline serum creatinine (0.97 [0.95-0.99], p = 0.01) and high baseline proteinuria (0.37, [0.19-0.74], p = 0.005) negatively predicted PERR. Positive predictors of PERR at 12 and 24 months were baseline anti-Sm positivity (OR [95%CI]: 6.2 [1.21-31.7], p = 0.029; 19.8 [2.01-186.7], p = 0.009, respectively) and having achieved PERR at 6 months (14.4 [3.28-63.6]; 11.7 [2.7-48.7], p = 0.001 for both).
CONCLUSIONS
Add-on therapy with belimumab led to durable renal response in patients with LN in a real-life setting.
背景
贝鲁单抗最近被批准用于治疗狼疮性肾炎（LN）。
目的
评估 LN 患者接受贝鲁单抗治疗的肾脏反应及其预测因素。
患者和方法
我们考虑了所有符合 SLEDAI-2K 肾脏标准且/或估算肾小球滤过率（eGFR）≤60ml/min/1.73m，抗 dsDNA 阳性和/或低 C3/C4的患者，他们入组了多中心意大利狼疮队列 BeRLiSS（贝鲁单抗在真实生活环境中的研究），接受每月静脉注射贝鲁单抗 10mg/kg 联合标准治疗。主要肾脏反应（PERR）定义为蛋白尿≤0.7g/24h，eGFR≥60ml/min/1.73m，无挽救治疗，为主要结局。完全肾脏反应（CRR；蛋白尿<0.5g/24h，eGFR≥90ml/min/1.73m）为次要结局。通过多变量逻辑回归评估 6、12、24 个月时 PERR 的发生率和预测因素。
结果
在 BeRLiSS 的 466 例 SLE 患者中，91 例符合纳入标准，其中 79 例为女性，中位年龄 41.0（33.0-47.0）岁，中位随访时间 22.0（12.0-36.0）个月。64 例（70.3%）达到 PERR，其中 38.4%达到 CRR。在 6 个月时达到 PERR 的患者中，86.7%在整个随访期间维持反应。多变量分析显示，高血压（比值比[95%CI]：0.28[0.09-0.89]，p=0.032）、基线血清肌酐升高（0.97[0.95-0.99]，p=0.01）和基线蛋白尿升高（0.37，[0.19-0.74]，p=0.005）是 PERR 的负预测因素。12 个月和 24 个月时 PERR 的阳性预测因素是基线抗 Sm 阳性（比值比[95%CI]：6.2[1.21-31.7]，p=0.029；19.8[2.01-186.7]，p=0.009）和 6 个月时达到 PERR（14.4[3.28-63.6]；11.7[2.7-48.7]，p=0.001）。
结论
贝鲁单抗联合治疗可使 LN 患者在真实环境中获得持久的肾脏反应。
Zotero 插件