Buddhavarapu Venkata, Dhillon Gagandeep, Grewal Harpreet, Sharma Pranjal, Kashyap Rahul, Surani Salim
Department of Medicine, Banner Baywood Medical Center, Banner Health, Mesa, AZ 85206, United States.
Department of Medicine, UM Baltimore Washington Medical Center, Glen Burnie, MD 21061, United States.
World J Diabetes. 2024 Aug 15;15(8):1793-1801. doi: 10.4239/wjd.v15.i8.1793.
The incidence of diabetes mellitus type 1 (DM1) has been rising worldwide because of improvements in diagnostic techniques and improved access to care in countries with lower socioeconomic status. A new anti-CD4 antibody, Tep-lizumab, has been shown to delay the progression of DM1 and is the only medication approved for this indication. However, more information is needed about the safety profile of this drug.
To identify the odds ratios (OR) of systems-based adverse effects for Teplizumab when compared to Placebo.
An extensive systematic review was conducted from the inception of the medication until December 31, 2023. All clinical trials and studies that evaluated Teplizumab placebo were included in the initial review. The study protocol was designed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines guidelines and was registered in PROSPERO (ID: CRD42024496169). Crude OR were generated using RevMan Software version 5.4.
After screening and review, 5 studies were selected to determine the risk of adverse effects of teplizumab compared to placebo. A total of 561 patients were included in the study population. Total adverse effects and system-based adverse effects were studied and reported. We determined that patients receiving Teplizumab had a higher risk of developing gastrointestinal (GI) (OR = 1.60, 95%CI: 1.01-2.52, = 0.04), dermatological (OR = 6.33, 95%CI: 4.05-9.88, < 0.00001) and hematological adverse effects (OR = 19.03, 95%CI: 11.09-32.66, < 0.00001). These patients were also significantly likely to have active Epstein-Barr Virus infection (OR = 3.16, 95%CI: 1.51-6.64, < 0.002). While our data showed that patients receiving Teplizumab did have a higher incidence of total adverse effects placebo, this finding did not reach statistical significance (OR = 2.25, 95%CI: 0.80-6.29, = 0.12).
Our systematic review suggests that Teplizumab patients are at risk for significant adverse effects, primarily related to GI, dermatological, and hematological systems. The total adverse effect data is limited as study populations are small. More studies should be conducted on this medication to better inform the target population of potential adverse effects.
由于诊断技术的改进以及社会经济地位较低国家医疗服务可及性的提高，全球1型糖尿病（DM1）的发病率一直在上升。一种新的抗CD4抗体替普珠单抗已被证明可延缓DM1的进展，并且是唯一被批准用于该适应症的药物。然而，关于这种药物的安全性还需要更多信息。
确定与安慰剂相比，替普珠单抗基于系统的不良反应的比值比（OR）。
从该药物问世至2023年12月31日进行了广泛的系统评价。所有评估替普珠单抗与安慰剂的临床试验和研究都纳入了初步评价。研究方案是按照系统评价和Meta分析的首选报告项目指南设计的，并在国际前瞻性系统评价注册库（PROSPERO）中注册（编号：CRD42024496169）。使用RevMan 5.4软件生成粗OR。
经过筛选和评价，选择了5项研究来确定替普珠单抗与安慰剂相比的不良反应风险。研究人群共纳入561例患者。对总不良反应和基于系统的不良反应进行了研究和报告。我们确定接受替普珠单抗治疗的患者发生胃肠道（GI）不良反应的风险更高（OR = 1.60，95%CI：1.01 - 2.52，P = 0.04）、皮肤不良反应（OR = 6.33，95%CI：4.05 - 9.88，P < 0.00001）和血液学不良反应的风险更高（OR = 19.03，95%CI：11.09 - 32.66，P < 0.00001）。这些患者也显著更有可能发生活动性EB病毒感染（OR = 3.16，95%CI：1.51 - 6.64，P < 0.002）。虽然我们的数据显示接受替普珠单抗治疗的患者总不良反应发生率确实高于安慰剂组，但这一发现未达到统计学显著性（OR = 2.25，95%CI：0.80 - 6.29，P = 0.12）。
我们的系统评价表明，使用替普珠单抗的患者有发生重大不良反应的风险，主要与胃肠道、皮肤和血液系统有关。由于研究人群规模较小，总不良反应数据有限。应该对这种药物进行更多研究，以便更好地告知目标人群潜在的不良反应。
