Amr Elrosasy, Dalal Sabbagh, Mohammad Assaf, Husam Tarakhan, Ahmad Afyouni, Marwa O. Elgendy, Lamiaa N. Abdelaty, Refaat H. Omar, Ahmed Hamdy Zabady
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We assessed efficacy outcomes such as high-sensitivity C-reactive protein (hs-CRP), serum amyloid A (SAA), and both high-density lipoprotein (HDL) and low-density lipoprotein (LDL), as well as safety outcomes, including adverse events (AEs) and infections. Pooled results were calculated using the random effects model and inverse variance method, with mean differences (MD) and risk ratios (RR) presented alongside 95% confidence intervals (CI).</p><h3>Results</h3><p>Our review included three RCTs with a total of 473 patients. Compared to the placebo group, patients treated with ziltivekimab showed significantly lower levels of hs-CRP, fibrinogen, and SAA (MD = − 51.64, 95% CI [− 73.73 to − 29.56], <i>P</i> < 0.00001; MD = − 48.23, 95% CI [− 61.73 to − 34.72], <i>P</i> < 0.00001; MD = − 26.34, 95% CI [− 38.63 to − 14.04], <i>P</i> < 0.0001, respectively). There was a notable increase in LDL and HDL levels (MD = 5.92, 95% CI [2.53 to 9.31], <i>P</i> = 0.0006, I<sup>2</sup> = 0%; MD = − 5.73, 95% CI [3.75 to 7.71], <i>P</i> < 0.00001, I<sup>2</sup> = 0%, respectively). No significant difference in AEs or infections was observed between the two groups. Meta-regression analysis indicated a significant linear relationship between the dose of ziltivekimab and its effect on hs-CRP levels.</p><h3>Conclusion</h3><p>Ziltivekimab showed promise in significantly lowering inflammatory markers without a significant impact on AEs or infections, positioning it as a valuable treatment option for patients with chronic kidney disease CKD who are susceptible to inflammatory diseases, particularly atherosclerosis and autoimmune conditions.</p></div>","PeriodicalId":577,"journal":{"name":"Future Journal of Pharmaceutical Sciences","volume":"10 1","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://fjps.springeropen.com/counter/pdf/10.1186/s43094-024-00723-0","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of ziltivekimab in patients with chronic kidney disease susceptible to inflammatory diseases: a systematic review and meta-analysis of randomized controlled trials\",\"authors\":\"Amr Elrosasy, Dalal Sabbagh, Mohammad Assaf, Husam Tarakhan, Ahmad Afyouni, Marwa O. 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引用次数: 0
摘要
背景慢性肾脏病（CKD）患者有可能因持续炎症而患上动脉粥样硬化和炎症性贫血（AI）等疾病。Ziltivekimab是一种靶向白细胞介素-6的抗体，目前正在研究它降低这些患者炎症指标的潜力。方法根据PRISMA指南，我们搜索了截至2023年8月20日的相关随机对照试验（RCT），并使用RevMan 5.4软件分析了数据。研究时间跨度为 2023 年 2 月 18 日至 2023 年 9 月 23 日。我们评估了高敏 C 反应蛋白 (hs-CRP)、血清淀粉样蛋白 A (SAA)、高密度脂蛋白 (HDL) 和低密度脂蛋白 (LDL) 等疗效结果，以及不良事件 (AE) 和感染等安全性结果。采用随机效应模型和逆方差法计算汇总结果，并列出平均差（MD）和风险比（RR）以及 95% 的置信区间（CI）。与安慰剂组相比，接受 ziltivekimab 治疗的患者的 hs-CRP、纤维蛋白原和 SAA 水平明显降低（MD = - 51.64，95% CI [- 73.73 to - 29.56]，P < 0.00001；MD = - 48.23，95% CI [- 61.73 to - 34.72]，P < 0.00001；MD = - 26.34，95% CI [- 38.63 to - 14.04]，P < 0.0001）。低密度脂蛋白和高密度脂蛋白水平显著增加（MD = 5.92，95% CI [2.53 to 9.31]，P = 0.0006，I2 = 0%；MD = - 5.73，95% CI [3.75 to 7.71]，P <0.00001，I2 = 0%）。两组在AEs或感染方面无明显差异。元回归分析表明，齐尔特韦基单抗的剂量与其对hs-CRP水平的影响之间存在显著的线性关系。结论齐尔特韦基单抗有望显著降低炎症指标，而不会对AEs或感染产生显著影响，因此对于易患炎症性疾病（尤其是动脉粥样硬化和自身免疫性疾病）的慢性肾病CKD患者来说，它是一种有价值的治疗选择。
Efficacy and safety of ziltivekimab in patients with chronic kidney disease susceptible to inflammatory diseases: a systematic review and meta-analysis of randomized controlled trials
Background
Patients with chronic kidney disease (CKD) are at risk of developing conditions such as atherosclerosis and inflammation-induced anemia (AI) due to persistent inflammation. Ziltivekimab, an antibody targeting interleukin-6, is being studied for its potential to reduce inflammatory markers in these patients.
Methods
Following PRISMA guidelines, we searched for relevant randomized controlled trials (RCTs) up to August 20, 2023, and analyzed the data using RevMan 5.4 software. The study period spanned from February 18, 2023, to September 23, 2023. We assessed efficacy outcomes such as high-sensitivity C-reactive protein (hs-CRP), serum amyloid A (SAA), and both high-density lipoprotein (HDL) and low-density lipoprotein (LDL), as well as safety outcomes, including adverse events (AEs) and infections. Pooled results were calculated using the random effects model and inverse variance method, with mean differences (MD) and risk ratios (RR) presented alongside 95% confidence intervals (CI).
Results
Our review included three RCTs with a total of 473 patients. Compared to the placebo group, patients treated with ziltivekimab showed significantly lower levels of hs-CRP, fibrinogen, and SAA (MD = − 51.64, 95% CI [− 73.73 to − 29.56], P < 0.00001; MD = − 48.23, 95% CI [− 61.73 to − 34.72], P < 0.00001; MD = − 26.34, 95% CI [− 38.63 to − 14.04], P < 0.0001, respectively). There was a notable increase in LDL and HDL levels (MD = 5.92, 95% CI [2.53 to 9.31], P = 0.0006, I2 = 0%; MD = − 5.73, 95% CI [3.75 to 7.71], P < 0.00001, I2 = 0%, respectively). No significant difference in AEs or infections was observed between the two groups. Meta-regression analysis indicated a significant linear relationship between the dose of ziltivekimab and its effect on hs-CRP levels.
Conclusion
Ziltivekimab showed promise in significantly lowering inflammatory markers without a significant impact on AEs or infections, positioning it as a valuable treatment option for patients with chronic kidney disease CKD who are susceptible to inflammatory diseases, particularly atherosclerosis and autoimmune conditions.
期刊介绍：
Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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