贝利尤单抗治疗中重度系统性红斑狼疮的临床疗效和安全性研究

Clinical Efficacy and Safety Study of Belimumab in the Treatment of Moderate to Severe Systemic Lupus Erythematosus

目的探讨贝利尤单抗治疗中重度系统性红斑狼疮(SLE)的临床疗效及安全性。方法收集2019年11月至2022年6月于宁夏回族自治区人民医院就诊的64例中重度SLE患者的临床资料,根据是否加用贝利尤单抗分为对照组(34例)和贝利尤治疗组(30例),对比两组患者治疗前及治疗后4、8、12、24周的临床特征、狼疮疾病活动指数(SLEDAI)、病情缓解率及不良事件发生情况。结果两组患者治疗前一般资料、临床特征及激素和免疫抑制剂的使用差异均无统计学意义(P均>0.05)。两组患者治疗8周后C3、C4水平均升高,贝利尤治疗组C3水平在治疗4周起高于对照组(P<0.05),两组间比较C4差异无统计学意义(P>0.05)。与治疗前相比,两组治疗后抗dsDNA抗体水平、血沉(ESR)、医生整体评估(PGA)、SLEDIA评分、每日泼尼松剂量均降低(P均<0.05),贝利尤治疗组的抗dsDNA抗体水平在第12周起低于对照组,SLEDAI评分和每日泼尼松剂量在第8周起低于对照组(P均<0.05)。治疗后两组的免疫球蛋白G(IgG)、总B细胞均较治疗前降低,两组间比较差异无统计学意义(P均>0.05)。两组治疗24周后的CD4^(+)/CD8^(+)水平与治疗前比较差异无统计学意义(P均>0.05),治疗24周后两组间比较差异无统计学意义(P均>0.05)。治疗24周后贝利尤治疗组肾脏缓解率和带药临床缓解率均高于对照组(P均<0.05)。两组间不良事件发生率差异无统计学意义(P均>0.05)。结论贝利尤单抗在治疗中重度SLE方面具有较好的临床疗效和安全性,能更快降低疾病活动度、减量激素,更早达到临床缓解。

Objective To investigate the clinical efficacy and safety of belimumab in the treatment of moderate to severe systemic lupus erythematosus(SLE).Methods Clinical data of 64 patients with moderate-to-severe SLE attending Ningxia Hui Autonomous People’s Hospital from November 2019 to June 2022 were collected and divided into control group(34 cases)and belimumab treatment group(30 cases)according to whether or not belimumab was added.The clinical characteristics,SLE Disease Activity Index(SLEDIA),remission rate and occurrence of adverse events of the 2 groups were compared before and 4,8,12 and 24 weeks after treatment.Results There was no statistical difference between the two groups in terms of general information,clinical characteristics and use of glucocorticoids and immunosuppressants before treatment(P all>0.05).Complement C3 and C4 levels increased in both groups after 8 weeks of treatment,with higher C3 in the belimumab-treated group than in the control group from 4 weeks of treatment(P<0.05),and no difference in C4 between the two groups(P>0.05).Anti-dsDNA antibody levels,erythrocyte sedimentation rate(ESR),Physician’s Global Assessment(PGA),SLEDIA score and daily prednisone dose were all lower in both groups after treatment compared to those of pre-treatment(P all<0.05),with anti-dsDNA antibody levels lower in the belimumab-treated group than in the control group from week 12 onwards and SLEDAI score and daily prednisone dose lower than in the control group from week 8 onwards(P all<0.05).Immunoglobulin G(IgG),total B cells decreased after treatment in both groups,with no significant differences between the two groups(P all>0.05).No statistically significant differences were observed in CD4^(+)/CD8^(+)levels between the two groups when compared with those of before 24 weeks of treatment(P all>0.05),and no statistically significant differences were observed between the two groups after 24 weeks of treatment(P all>0.05).The rates of renal remission and clinical remission with medication were higher in the belimumab-treated group than in the control group after 24 weeks of treatment(P all<0.05).There was no statistically significant difference in the incidence of adverse events between the two groups(P all>0.05).Conclusion Belimumab had shown good clinical efficacy and safety in the treatment of moderate to severe SLE,with faster reduction in disease activity,glucocorticoid tapering and earlier clinical remission.