贝利木单抗治疗系统性红斑狼疮的临床观察

Clinical observations in the treatment of systemic lupus erythematosus with belimumab

目的探索贝利木单抗治疗系统性红斑狼疮(SLE)的有效性和安全性。方法收集北京协和医院自2020年5月1日起至2022年2月1日期间使用贝利木单抗的SLE患者。利用Mann-Whitney U检验和t检验分析患者加用贝利木单抗前后的临床表现、SLEDAI-2000评分、实验室检查结果及不良反应。结果81例患者纳入本研究,在免疫抑制剂药物用量不变的基础上,加用贝利木单抗可以明显降低SLE患者的SLEDAI-2000评分[10.00(7.75,12.00)分与4.00(3.75,6.00)分,Z=-5.38,P<0.001],ESR[19.50(12.75,32.25)mm/1 h与14.00(7.75,20.25)mm/1 h,Z=-3.71,P=0.003];抗dsDNA抗体滴度[300.00(117.00,864.00)与183.00(100.00,471.00),Z=-4.68,P=0.001];同时补体升高C3[0.78(0.62,0.97)g/L与0.69(0.55,0.84)g/L,Z=-4.68,P<0.001];补体C4[0.12(0.08,0.19)g/L与0.10(0.05,0.14)g/L,Z=-4.78,P<0.001];降低患者糖皮质激素(激素)使用量[10.00(7.50,22.50)mg与7.50(5.00,10.00)mg,Z=-4.90,P<0.001]。另外,患者的IgG、IgA、IgM明显下降,但1例患者因免疫球蛋白过低停药。结论贝利木单抗可以缓解SLE患者疾病活动度,减少激素的用量,且耐受性良好。

ObjectiveTo further investigate the safety and efficacy of Belimumab in the treatment of patients with systemic lupus erythematosus(SLE).MethodsAll SLE patients treated with Belimumab from May 1,2020 to February 1,2022 in Peking Union Medical College Hospital were retrospectively collected and analyzed.The clinical manifestations,the Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2000)score,and laboratory test such as levels of anti-dsDNA antibody,the medication before and after Belimumab treatment,adverse events were collected.Normally distributed data were tested using the t-test,otherwise the Wilcoxon paired signed rank test was used.ResultsA total of 81 patients were enrolled in this study.The use of belimumab could significantly decrease the SLEDAI-2000 score[10.00(7.75,12.00)vs.4.00(3.75,6.00),Z=-5.38,P<0.001],ESR of SLE patients[19.50(12.75,32.25)mm/1 h vs.14.00(7.75,20.25)mm/1 h,Z=-3.71,P=0.003],anti-dsDNA titer detected by CLIFT[300.00(117.00,864.00)vs.183.00(100.00,471.00),Z=-4.15,P=0.001],meanwhile,increase the complement C3[0.78(0.62,0.97)g/L vs.0.69(0.55,0.84)g/L,Z=-4.68,P<0.001],and the complement C4[0.12(0.08,0.19)g/L vs.0.10(0.05,0.14)g/L,Z=-4.78,P<0.001].We also observed that with the use of Belimumab,the dosage of Glucocorticoids decreased significantly,which were[10.00(7.50,22.50)mg vs.7.50(5.00,10.00)mg,Z=-4.90,P<0.001].In addition,the antibody of IgG,IgA and IgM decreased significantly.Only one patient stopped the administration of Belimumab due to the low level of immunoglobulin.ConclusionBelimumab can alleviate disease activity of patients with SLE and help in safely tapering the daily dose of glucocorticoid with good safety.