贝利尤单抗治疗中国成人狼疮肾炎患者有效性评价:一项24周、回顾性、单中心、真实世界的研究

Effectiveness and safety of belimumab in Chinese adult lupus nephritis patients:a 24-week retrospective single-center real-world study

目的探究在真实世界背景下贝利尤单抗在中国成人狼疮肾炎(lupus nephritis,LN)患者中的有效性及安全性。方法本研究为回顾性队列研究,选取2021年6月至2022年12月于徐州医科大学附属医院风湿免疫科就诊,首次诊断LN或因LN复发选择接受规律贝利尤单抗联合传统药物治疗的LN患者30例作为贝利尤单抗组,同时应用倾向性评分匹配的统计学方法,选取同期仅接受传统药物治疗的初治/复发LN患者30例作为标准治疗(standard of care,SoC)组。比较两组患者治疗24周后肾脏完全缓解率(complete remission,CR)、疾病活动度、24 h尿蛋白定量、糖皮质激素摄入量以及不良事件发生情况。结果两组患者基线人口学资料、补体C3、补体C4、抗双链DNA抗体滴度、24 h尿蛋白定量、疾病活动度之间差异无统计学意义(P>0.05)。随访至第24周,21例贝利尤单抗组患者达到肾脏CR,较SoC组CR应答率更高(21例比12例),差异有统计学意义(P=0.037)。与SoC组相比,贝利尤单抗组患者24 h尿蛋白定量更低[346.50(183.75,571.00)mg比611.50(360.00,1450.00)mg]、系统性红斑狼疮疾病活动性指数2000得分更低[(3.93±2.79)分比(5.70±3.14)分]、泼尼松摄入量更少[(11.67±4.34)mg/d比(22.42±9.23)mg/d],差异均具有统计学意义(P<0.05)。两组患者不良事件发生情况差异无统计学意义(P>0.05)。结论传统药物治疗联合贝利尤单抗能够显著改善LN患者病情、提高肾脏CR,降低患者24 h尿蛋白定量水平,改善疾病活动度,同时减少糖皮质激素摄入。

Objective To explore the effectiveness and safety of belimumab in Chinese adult lu-pus nephritis(LN)patients under a real-world setting.Methods For this retrospective cohort study,30 LN patients received belimumab plus standard of care(SoC)due to a new onset or a relapse of LN from June 2021 to December 2022.And 30 matched patients only treated with SoC after propensity score match-ing(PSM)at the same period were also enrolled.After 24-week follow-ups,renal complete remission(CR),disease activity index,24 h urine protein level,dose of prednisone and incidence of adverse events were compared.Results No statistically significant differences existed in baseline demographics,com-plement C3/C4,anti-dsDNA autoantibody titer,24 h urine protein level or disease activity index.At Week 24,21/30 patients achieved renal CR and it was higher than that of SoC group(21 vs 12,P=0.037).As compared with SoC group,belimumab group had lower levels of 24 h urine protein[346.50(183.75,571.00)mg vs 611.50(360.00,1450.00)mg],SLEDAI-2K(SLE disease activity index,SLEDAI-2K)score[(3.93±2.79)vs(5.70±3.14)]and daily prednisone dose[(11.67±4.34)mg/d vs(22.42±9.23)mg/d](P<0.05).Furthermore,the incidence of adverse events between two group was comparable(P>0.05).Conclusions Belimumab plus SoC may alleviate LN,boost the rate of renal CR,lower 24 h urine pro-tein levels,improve disease activity and reduce the intake of prednisone.