使用单一指标评估贝利木单抗对成年系统性红斑狼疮患者的疗效:荟萃分析和系统综述

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Current Therapeutic Research-clinical and Experimental Pub Date : 2024-01-01 DOI:10.1016/j.curtheres.2024.100738
Chisato Yoshijima BSPharm , Yosuke Suzuki PhD , Ayako Oda BSPharm , Ryota Tanaka PhD , Hiroyuki Ono BSPharm , Hiroki Itoh PhD , Keiko Ohno PhD
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引用次数: 0

摘要

背景贝利木单抗是首个获准用于系统性红斑狼疮(SLE)的抗体药物,它是一种抑制可溶性B淋巴细胞刺激蛋白的全人源单克隆抗体。在临床试验中,贝利木单抗的疗效是通过一项综合指标来评估的。本研究的主要目的是进行一项荟萃分析,利用常规临床实践中使用的单一指标来评估贝利木单抗的疗效,而不是开发阶段临床试验中使用的综合疗效指标。方法检索了多个数据库,以确定截至2021年12月1日发表的关于贝利木单抗对成年系统性红斑狼疮患者疗效的随机对照试验报告。从临床试验数据中,我们使用单一指标评估了疗效,包括系统性红斑狼疮疾病活动指数(SLEDAI)、英伦三岛狼疮评估组指数和医生总体评估。此外,还对安全性进行了评估。使用 Review Manager 5.4 对数据进行了综合和分析。本研究方案已在 UMIN 临床试验注册中心注册(注册号:UMIN000052846)。其中 5 份报告纳入了疗效评估,9 份报告纳入了安全性评估。主要终点是SLEDAI。与安慰剂相比,明显有更多的贝利木单抗治疗患者的SLEDAI降低了≥4分(相对风险为1.28;95%置信区间为1.16-1.40;P< 0.00001)。贝利木单抗组的其他疗效终点也有显著改善。结论本荟萃分析使用系统性红斑狼疮临床指南推荐的各种单一指标对临床试验数据进行了评估,验证了在标准治疗的基础上加用贝利木单抗对中重度系统性红斑狼疮具有疗效。
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Usefulness of Belimumab in Adult Patients With Systemic Lupus Erythematosus Evaluated Using Single Indexes: A Meta-Analysis and Systematic Review

Background

Belimumab is the first antibody drug approved for systemic lupus erythematosus (SLE), and is a fully human monoclonal antibody that inhibits soluble B lymphocyte stimulator protein. In clinical trials, a composite index was used to assess efficacy of belimumab. However, clinical guidelines on SLE treatment currently use single efficacy indexes.

Objective

The main objective of this study was to perform a meta-analysis to evaluate the efficacy of belimumab utilizing single indexes used in routine clinical practice, rather than the composite efficacy index used in clinical trials during the development phase. As a secondary endpoint, safety was also evaluated.

Methods

Several databases were searched to identify reports published up to December 1, 2021 on randomized controlled trials examining the efficacy of belimumab in adult patients with SLE. From the clinical trial data, efficacy was evaluated using single indexes including the SLE Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group Index, and Physician Global Assessment. Safety was also assessed. Data were synthesized and analyzed using Review Manager 5.4. This study protocol was registered in the UMIN Clinical Trials Registry (Registration number: UMIN000052846).

Results

The search identified 12 reports that met the inclusion criteria. Five reports were included in efficacy evaluation and 9 in safety evaluation. The primary endpoint was SLEDAI. Significantly more belimumab-treated patients achieved a ≥4-point reduction in SLEDAI (relative risk 1.28; 95% confidence interval, 1.16–1.40; P < 0.00001) compared with placebo. Other efficacy endpoints were also improved significantly in the belimumab group. No difference in safety was found between belimumab and placebo.

Conclusions

The present meta-analysis evaluating clinical trial data using various single indexes recommended by clinical guidelines for SLE verifies that addition of belimumab to standard of care is efficacious for moderate-to-severe SLE.

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CiteScore
3.50
自引率
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发文量
31
审稿时长
3 months
期刊介绍: We also encourage the submission of manuscripts presenting preclinical and very preliminary research that may stimulate further investigation of potentially relevant findings, as well as in-depth review articles on specific therapies or disease states, and applied health delivery or pharmacoeconomics. CTR encourages and supports the submission of manuscripts describing: • Interventions designed to understand or improve human health, disease treatment or disease prevention; • Studies that focus on problems that are uncommon in resource-rich countries; • Research that is "under-published" because of limited access to monetary resources such as English language support and Open Access fees (CTR offers deeply discounted English language editing); • Republication of articles previously published in non-English journals (eg, evidence-based guidelines) which could be useful if translated into English; • Preclinical and clinical product development studies that are not pursued for further investigation based upon early phase results.
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