Huang Shirley P, Snedecor Sonya J, Nanji Sakina, Lloyd Emily, Bell Christopher F
GlaxoSmithKline, Research Triangle Park, NC, USA.
OPEN Health, Bethesda, MD, USA.
Rheumatol Ther. 2022 Aug;9(4):975-991. doi: 10.1007/s40744-022-00454-9. Epub 2022 May 21.
Belimumab is a recombinant human monoclonal antibody that binds to soluble B-lymphocyte stimulator and inhibits its biological activity. Since receiving approvals for the treatment of systemic lupus erythematosus (SLE), several observational studies have investigated the effectiveness of belimumab in the real-world setting. This study reports a systematic review and meta-analysis of the literature to evaluate the real-world effectiveness of belimumab for the treatment of SLE.
A literature search following PRISMA Guidelines and limited to studies in English was performed (2014-2020) to identify relevant studies reporting effectiveness outcomes of belimumab in patients with SLE. A modified version of the Newcastle-Ottawa Scale was used to assess study quality. Outcomes, including SLE Disease Activity Index (SLEDAI) score, prednisone-equivalent use, and SLE flare were pooled and analyzed using statistical aggregation methods.
The literature search identified 514 articles for initial review. Of these, 17 articles were suitable for data extraction and summary. Baseline characteristics of patients in real-world studies were generally similar to those of relevant clinical trials, including age, sex, disease duration, SLEDAI score, and prednisone-equivalent use. Real-world use of belimumab was associated with reductions in SLEDAI score (mean baseline score to month 6: 10.1-4.4; 57% reduction), prednisone-equivalent dosing (mean baseline dose to month 6: 12.1 mg/day to 6.9 mg/day; 43% reduction), and flare frequency (12 months prior to belimumab to 12 months after belimumab: 1.15-0.39 mean flares per patient per year; 66% reduction). Long-term data (up to 2 years post-treatment initiation) for SLEDAI score and prednisone-equivalent dose indicated that improvements in both outcomes continue over time among patients remaining on therapy.
In the real-world setting, observed outcomes with belimumab for the treatment of SLE are consistent with those reported from randomized clinical trials. Improvements persist long-term for SLEDAI activity and prednisone-equivalent use with belimumab.
贝利尤单抗是一种重组人单克隆抗体，可与可溶性B淋巴细胞刺激因子结合并抑制其生物活性。自获批用于治疗系统性红斑狼疮（SLE）以来，多项观察性研究探讨了贝利尤单抗在实际应用中的有效性。本研究报告了一项系统评价和文献荟萃分析，以评估贝利尤单抗治疗SLE的实际有效性。
按照PRISMA指南进行文献检索，检索范围限于2014年至2020年的英文研究，以确定报告贝利尤单抗在SLE患者中有效性结果的相关研究。使用纽卡斯尔-渥太华量表的修订版评估研究质量。采用统计汇总方法对包括SLE疾病活动指数（SLEDAI）评分、泼尼松等效用量和SLE病情复发等结果进行汇总和分析。
文献检索共识别出514篇文章用于初步审查。其中，17篇文章适合进行数据提取和总结。实际应用研究中患者的基线特征与相关临床试验中的患者基本相似，包括年龄、性别、病程、SLEDAI评分和泼尼松等效用量。实际应用贝利尤单抗与SLEDAI评分降低（从基线平均评分到第6个月：10.1 - 4.4；降低57%）、泼尼松等效剂量降低（从基线平均剂量到第6个月：12.1毫克/天降至6.9毫克/天；降低43%）以及病情复发频率降低（使用贝利尤单抗前12个月到使用后12个月：每位患者每年平均病情复发次数从1.15降至0.39；降低66%）相关。SLEDAI评分和泼尼松等效剂量的长期数据（治疗开始后长达2年）表明，继续接受治疗的患者中，这两项结果随时间推移持续改善。
在实际应用中，观察到的贝利尤单抗治疗SLE的结果与随机临床试验报告的结果一致。使用贝利尤单抗治疗，SLEDAI活动度和泼尼松等效用量的改善在长期内持续存在。
