Division of Rheumatology, Cedars-Sinai, Los Angeles, CA, USA.
163693Department of Rheumatology, Hokkaido University Hospital, Sapporo, Japan.
Lupus. 2022 Nov;31(13):1649-1659. doi: 10.1177/09612033221131183. Epub 2022 Oct 7.
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that affects multiple organ systems. Belimumab, a targeted human monoclonal antibody, binds to and inhibits soluble B-lymphocyte stimulator. The safety and efficacy of belimumab has consistently been demonstrated in multiple clinical trials for the treatment of patients with active SLE. Integration of these data provides an additional opportunity to explore the safety of belimumab in a larger and more diverse population. This post hoc pooled analysis of clinical studies evaluated the safety profile of belimumab versus placebo in adults with SLE.
This was a pooled post hoc analysis of 52-week safety data from one Phase 2 and five Phase 3 belimumab trials in adult patients with SLE. Patients received ≥1 dose of placebo or belimumab (1, 4, or 10 mg/kg intravenous or 200 mg subcutaneous), plus standard therapy. Outcomes included the incidence of adverse events (AEs), serious AEs (SAEs), severe AEs, AEs of special interest (AESI), and mortality.
Across 4170 patients (placebo: N = 1355; belimumab: N = 2815), baseline demographics, disease characteristics, and treatment exposure were similar for placebo and belimumab. Most patients (placebo: 76.6%; belimumab: 81.0%) completed the protocol Week 52 visit. Overall, incidence of AEs, SAEs, severe AEs, AESI, and mortality were similar between groups. In both groups, the most commonly reported SAEs by system organ class were infections and infestations (placebo: 5.9%; belimumab: 5.4%) and renal and urinary disorders (placebo: 2.2%; belimumab: 1.7%). Additionally, a greater proportion of patients experienced AESI with belimumab versus placebo for post-infusion/injection systemic reactions (placebo: 8.1%; belimumab: 10.2%). Mortality rates were similar between groups (placebo: 0.4%; belimumab: 0.6%).
These results are consistent with those of the individual studies, BASE, BLISS-LN, and long-term extension studies, making belimumab one of the most studied SLE treatments for safety. Collectively, this evidence continues to support a positive benefit-risk profile of belimumab in the treatment of adult patients with SLE.
系统性红斑狼疮（SLE）是一种影响多个器官系统的慢性自身免疫性疾病。贝利木单抗是一种靶向人单克隆抗体，可结合并抑制可溶性 B 淋巴细胞刺激物。贝利木单抗在多项治疗活动性 SLE 患者的临床试验中始终显示出安全性和疗效。整合这些数据为在更大、更多样化的人群中探索贝利木单抗的安全性提供了额外的机会。本项针对临床研究的事后汇总分析评估了贝利木单抗与安慰剂在 SLE 成人患者中的安全性。
这是一项针对成人 SLE 患者的 52 周安全性数据的事后汇总分析，包括一项 2 期和 5 项 3 期贝利木单抗试验。患者接受了至少 1 剂安慰剂或贝利木单抗（1、4 或 10mg/kg 静脉或 200mg 皮下），联合标准治疗。结局包括不良事件（AE）、严重不良事件（SAE）、重度不良事件、特殊关注的不良事件（AESI）和死亡率。
在 4170 例患者（安慰剂：N=1355；贝利木单抗：N=2815）中，安慰剂和贝利木单抗的基线人口统计学、疾病特征和治疗暴露情况相似。大多数患者（安慰剂：76.6%；贝利木单抗：81.0%）完成了第 52 周方案访视。总体而言，两组间 AE、SAE、重度 AE、AESI 和死亡率相似。两组中，最常见的按系统器官分类报告的 SAE 为感染和寄生虫病（安慰剂：5.9%；贝利木单抗：5.4%）和肾脏和泌尿系统疾病（安慰剂：2.2%；贝利木单抗：1.7%）。此外，与安慰剂相比，贝利木单抗组有更多的患者出现输液/注射后全身反应的 AESI（安慰剂：8.1%；贝利木单抗：10.2%）。两组死亡率相似（安慰剂：0.4%；贝利木单抗：0.6%）。
这些结果与各项研究、BASE、BLISS-LN 和长期扩展研究的结果一致，使贝利木单抗成为安全性研究最多的 SLE 治疗药物之一。这些证据共同支持贝利木单抗在治疗成人 SLE 患者中的获益风险状况呈积极态势。
