贝利尤单抗联合标准方案治疗2例重型活动性狼疮肾炎的疗效观察

Belimumab combined with standard therapy in 2 cases of severe active lupus nephritis

目的:探讨贝利尤单抗联合标准方案治疗2例重型活动性狼疮肾炎(LN)的近期临床疗效和安全性。方法:前瞻性观察国家肾脏疾病临床医学研究中心诊治的2例重型活动性LN患者,在LN标准基础治疗上联合使用贝利尤单抗治疗,评估24周疗程中2例患者疾病转归和临床用药情况。结果:2例均为初发初治的女性LN患者,年龄分别为22岁和27岁;系统性红斑狼疮疾病活动度评分(SLE-DAI)分别为15分和17分;LN病理类型分别为Ⅳ-G(A)[活动指数(AI)13,慢性化指数(CI)0)和Ⅳ-G(AI 12,CI 0)。2例均在甲泼尼龙冲击(MP)治疗后口服泼尼松(起始45 mg/d、30 mg/d),并接受多靶点疗法(MT)或吗替麦考酚酯(MMF)诱导治疗。均在MP后2周内启动贝利尤单抗治疗,用药方案为10 mg/kg静脉输注,1次/2周×3次,1次/4周×5次,共8次。治疗满24周后评估疗效:1例获得肾脏完全缓解,SLE-DAI下降至2分(补体C30.593 g/L),1例获得肾脏部分缓解,SLE-DAI评分降至8分(蛋白尿0.78 g/24h、尿沉渣红细胞计数15.8个/HPF)。泼尼松减量至15 mg/d和10 mg/d,均无感染和肾功能恶化。结论:贝利尤单抗联合标准化方案治疗成人重型活动性LN,近期疗效好,SLE-DAI和肾脏损害指标缓解明显,激素可撤减至较低剂量维持。

Objective:To discuss the short-term clinical efficacy and safety of belimumab combined with standard therapy in treatment of severe active lupus nephritis(LN).Methodology:2 patients with severe active LN who were dignosed and treated in the National Clinical Research Center of Kidney Disease were prospectively observed.They accepted belimumab in combination with standard therapy for 24 week.The disease outcome and clinical medication of 2 patients were evaluated.Results:Two patients with LN observed in this study were female and newly diagnosed,the age was 22 and 27 years old respectively,SLE-DAI were 15 and 17,and the pathological types of LN were IV-G(A)(AI 13,CI 0)and IV-G(AI 12,CI 0).Both patients received methylprednisolone pulse(MP)therapy(2.5 g,1.5 g),followed by oral prednisone(45 mg/d,30 mg),and received multi-target therapy or mycophenolate mofetil(MMF)as induction therapy.Both patients started beilimumab regimen(10 mg/kg infuse on weeks 0,2,4,then every 4 weeks until weeks 24)within 2 weeks after MP.After 24 weeks of treatment,1 case achieved complete renal remission,SLE-DAI decreased to 2(complement C30.593 g/L),1 case achieved partial renal remission,and SLE-DAI decreased to 8(proteinuria 0.78 g/24 h,urinary sediment red blood cell count 15.8/HPF).To the week 24,dosage of prednisone in the two patients was reduced to 15 mg and 10 mg respectively,and there was no infection or deterioration of renal function.Conclusion:Belimumab combined with standard therapy is effective in treatment of adult severe active LN.The scores of SLE-DAI and renal damage are relieved obviously,and oral prednisone can be reduced to a lower dose.