Temporal, Drug Dose, and Sample Size Trends in the Efficacy of Omalizumab for Chronic Spontaneous Urticaria: A Cumulative Meta-Analysis

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Haiyan Qin, Xianjun Xiao, Di Qin, Wei Cao, Lu Wang, Menghan Xi, Zihao Zou, Qian Yang, Sijue Chen, Huilin Liu, Ying Li, Yunzhou Shi
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引用次数: 0

Abstract

What is Known and Objective. Omalizumab is a humanized anti-IgE antibody, which is used in the treatment of chronic spontaneous urticaria (CSU). This study aims to investigate the trends in the efficacy of omalizumab for CSU, focusing on temporal aspects, drug dosages, and sample sizes. Methods. Cochrane, OVID MEDLINE, Embase, Web of Science, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) from 1900 to January 2023. The primary outcome was the percentage of complete responders (defined as the weekly urticaria activity score as 0, UAS7 = 0). Secondary outcomes included the percentage of patients with UAS7 ≤ 6, the percentage of patients achieving a minimally necessary difference in weekly itch severity score (defined as a reduction from baseline in ISS7 of ≥5 points, ISS7 MID), and adverse events (AEs). A cumulative meta-analysis was performed with pooled risk ratio (RR) and 95% confidence intervals (CI). Publication bias was assessed by the contour-enhanced funnel plots with the trim-and-fill method, alongside Begg’s and Egger’s tests. Results and Discussion. Twelve randomized, placebo-controlled studies encompassing 2166 patients were analyzed. Compared with the placebo group, the omalizumab group exhibited significant increases in the proportion of patients achieving UAS7 = 0 [RR 5.18, 95% CI (3.97, 6.75), I2 = 14%], UAS7 ≤ 6 [RR 3.21, 95% CI (2.69, 3.83), I2 = 30%], and ISS7 MID responders [RR 1.50, 95% CI (1.39, 1.63), I2 = 33%]. AEs were similar between the omalizumab group and placebo group [RR 0.96, 95% CI (0.89, 1.03), I2 = 4%]. What is New and Conclusion. The cumulative meta-analysis confirmed that the efficacy outcomes for omalizumab have remained consistent over time, across different drug doses and sample sizes, with improved precision from newer studies. Omalizumab is confirmed to be safe and effective for CSU. It is also suggested to minimize redundant RCTs to conserve scientific and medical resources efficiently.

Abstract Image

奥马珠单抗治疗慢性自发性荨麻疹疗效的时间、药物剂量和样本量趋势:累积荟萃分析
已知信息和目标。奥马珠单抗是一种人源化抗 IgE 抗体,用于治疗慢性自发性荨麻疹(CSU)。本研究旨在调查奥马珠单抗治疗 CSU 的疗效趋势,重点关注时间方面、药物剂量和样本量。研究方法在Cochrane、OVID MEDLINE、Embase、Web of Science和ClinicalTrials.gov上检索了1900年至2023年1月的随机对照试验(RCT)。主要结果是完全应答者的百分比(定义为每周荨麻疹活动评分为 0,UAS7 = 0)。次要结果包括 UAS7≤6 的患者比例、每周瘙痒严重程度评分达到最小必要差异(定义为 ISS7 比基线降低≥5 分,ISS7 MID)的患者比例以及不良事件(AEs)。进行了累积荟萃分析,得出了汇总风险比 (RR) 和 95% 置信区间 (CI)。文献发表偏倚通过等高线增强漏斗图、修剪填充法以及 Begg's 和 Egger's 检验进行评估。结果与讨论共分析了 12 项随机安慰剂对照研究,包括 2166 名患者。与安慰剂组相比,奥马珠单抗组达到 UAS7 = 0 [RR 5.18,95% CI (3.97,6.75),I2 = 14%]、UAS7 ≤ 6 [RR 3.21,95% CI (2.69,3.83),I2 = 30%] 和 ISS7 MID 反应者 [RR 1.50,95% CI (1.39,1.63),I2 = 33%] 的患者比例显著增加。奥马珠单抗组与安慰剂组的AE相似[RR 0.96,95% CI (0.89,1.03),I2 = 4%]。新发现与结论。累积荟萃分析证实,随着时间的推移,不同药物剂量和样本大小的奥马珠单抗疗效结果保持一致,新研究的精确度也有所提高。奥马珠单抗被证实对 CSU 安全有效。此外,还建议尽量减少冗余的 RCT,以有效节约科学和医疗资源。
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来源期刊
CiteScore
4.10
自引率
5.00%
发文量
226
审稿时长
6 months
期刊介绍: The Journal of Clinical Pharmacy and Therapeutics provides a forum for clinicians, pharmacists and pharmacologists to explore and report on issues of common interest. Reports and commentaries on current issues in medical and pharmaceutical practice are encouraged. Papers on evidence-based clinical practice and multidisciplinary collaborative work are particularly welcome. Regular sections in the journal include: editorials, commentaries, reviews (including systematic overviews and meta-analyses), original research and reports, and book reviews. Its scope embraces all aspects of clinical drug development and therapeutics, including: Rational therapeutics Evidence-based practice Safety, cost-effectiveness and clinical efficacy of drugs Drug interactions Clinical impact of drug formulations Pharmacogenetics Personalised, stratified and translational medicine Clinical pharmacokinetics.
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