7例贝利尤单抗治疗系统性红斑狼疮的有效性和安全性分析

Efficacy and safety analysis of belimumab in the treatment of seven patients with systemic lupus erythematosus

摘要:

目的：评估贝利尤单抗在活动性或难治性系统性红斑狼疮（systemic lupus erythematosus，SLE）患者中的有效性和安全性。方法：回顾性分析重庆医科大学附属第二医院风湿免疫科7例使用贝利尤单抗半年以上的SLE患者临床资料，收集基线时系统性红斑狼疮疾病活动度评分（systemic lupus erythematosus disease activity index，SLEDAI）、泼尼松和免疫抑制剂用量、全血细胞计数、抗dsDNA抗体、C3和C4，同时收集肾受累患者的血清肌酐、尿常规和24 h蛋白尿，此后每3个月收集1次上述资料。同时记录随访过程中的不良事件。采用SPSS软件进行统计学分析。结果：7名患者（100%为女性）使用贝利尤单抗超过6个月。使用贝利尤单抗最常见的临床表现为血液系统受损（71.4%），其次为肾脏受损（42.9%）。随访过程中SLEDAI评分降低有统计学意义（P=0.006）。治疗期间抗dsDNA抗体水平明显降低（P=0.022），补体C4水平明显升高（P=0.017）。泼尼松平均剂量随着时间增长逐渐减少，泼尼松剂量在基线时达到最大值[（40.71±12.72） mg/d]，6个月时达到最小值[（14.64±15.91） mg/d]（P=0.001）。患者对贝利尤单抗耐受性较好，3名患者（42.9%）发生不良事件，1例为尿路感染，1例为带状疱疹，1例为病毒性结膜炎。结论：7例使用贝利尤单抗治疗的SLE患者，疾病活动性明显下降，糖皮质激素剂量明显减少，且具有较好的安全性。

Abstract:

Objective：To evaluate the efficacy and safety of belimumab in patients with active or refractory systemic lupus erythe－matosus（SLE）. Methods：Retrospective analysis was made of 7 patients with SLE who were treated with belimumab for more than half a year in the Department of Rheumatology and Immunology，The Second Affiliated Hospital of Chongqing Medical University. Systemic lupus erythematosus disease activity index（SLEDAI），prednisone and immunosuppressor dose，complete blood count，anti-dsDNA antibody，C3 and C4 were collected，and serum creatinine，urine routine，and total proteinuria of patients with renal involvement were collected at the same time. Then，the above indexes were collected every 3 months，and adverse events during follow-up were also recorded. SPSS software was used for statistical analysis. Results：Seven patients（all female） received belimumab for more than 6 months. The most common clinical manifestation of belimumab was impaired blood system（71.4%），followed by renal impairment（42.9%）. The SLEDAI decreased during the follow-up，with statistical significance（P=0.006）. During the treatment，the anti-dsDNA antibody level significantly decreased（P=0.022） and the complement C4 level significantly increased（P=0.017）. The mean dose of prednisone decreased over time，reaching a maximum at baseline and a minimum at 6 months[（40.71±12.72） mg/d to （14.64±15.91） mg/d，P=0.001）]. Patients were well tolerated with belimumab，and 3 patients（42.9%）had adverse events，including 1 case of urinary tract infection，1 case of herpes zoster，and 1 case of viral conjunctivitis. Conclusion：In 7 patients with systemic lupus erythe－matosus treated with belimumab，SLE disease activity and glucocorticoid dose were significantly reduced，with good safety.