背景:由于诊断技术的改进和社会经济地位较低的国家获得护理的机会的改善,世界范围内1型糖尿病(DM1)的发病率一直在上升。一种新的抗CD4抗体,Tep-lizumab,已被证明可以延迟DM1的进展,并且是唯一被批准用于该适应症的药物。然而,需要更多关于这种药物安全性的信息.
目的:确定与安慰剂相比,基于系统的Teplizumab不良反应的比值比(OR)。
方法:从药物开始到2023年12月31日进行了广泛的系统评价。所有评估Teplizumab与安慰剂的临床试验和研究都包括在初始审查中。该研究方案是使用系统评价和荟萃分析指南指南的首选报告项目设计的,并在PROSPERO(ID:CRD42024496169)中注册。使用RevMan软件版本5.4产生粗OR。
结果:经过筛选和审查,选择5项研究来确定teplizumab与安慰剂相比的不良反应的风险。总共561名患者被纳入研究人群。研究并报告了总不良反应和基于系统的不良反应。我们确定接受Teplizumab的患者发生胃肠道(GI)的风险较高(OR=1.60,95CI:1.01-2.52,P=0.04),皮肤科(OR=6.33,95CI:4.05-9.88,P<0.00001)和血液学不良反应(OR=19.03,95CI:11.09-32.66,P<0.00001)。这些患者也很可能患有活动性EB病毒感染(OR=3.16,95CI:1.51-6.64,P<0.002)。虽然我们的数据显示,接受Teplizumab的患者确实比安慰剂有更高的总不良反应发生率,结果无统计学意义(OR=2.25,95CI:0.80~6.29,P=0.12).
结论:我们的系统评价表明,Teplizumab患者存在显著不良反应的风险,主要与GI有关,皮肤病学,和血液系统。总的不良反应数据是有限的,因为研究人群很少。应该对这种药物进行更多的研究,以更好地告知目标人群潜在的不良反应。
BACKGROUND: 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.
OBJECTIVE: To identify the odds ratios (OR) of systems-based adverse effects for
Teplizumab when compared to Placebo.
METHODS: An extensive systematic review was conducted from the inception of the medication until December 31, 2023. All clinical trials and studies that evaluated
Teplizumab vs 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.
RESULTS: 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, P = 0.04), dermatological (OR = 6.33, 95%CI: 4.05-9.88, P < 0.00001) and hematological adverse effects (OR = 19.03, 95%CI: 11.09-32.66, P < 0.00001). These patients were also significantly likely to have active Epstein-Barr Virus infection (OR = 3.16, 95%CI: 1.51-6.64, P < 0.002). While our data showed that patients receiving
Teplizumab did have a higher incidence of total adverse effects vs placebo, this finding did not reach statistical significance (OR = 2.25, 95%CI: 0.80-6.29, P = 0.12).
CONCLUSIONS: 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.