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

      摘要
    • 摘要:
      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。

       

      Abstract:
      Objective  To explore the effectiveness and safety of belimumab in Chinese adult lupus 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 matching (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, complement 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 protein346.50(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 protein levels, improve disease activity and reduce the intake of prednisone.

       

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