Safety of teplizumab in patients with high-risk for diabetes mellitus type 1: A systematic review.

IF 4.2 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

World Journal of Diabetes Pub Date : 2024-08-15 DOI:10.4239/wjd.v15.i8.1793

Venkata Buddhavarapu, Gagandeep Dhillon, Harpreet Grewal, Pranjal Sharma, Rahul Kashyap, Salim Surani

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引用次数: 0

Abstract

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.

Aim: 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).

Conclusion: 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.

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特普利珠单抗对 1 型糖尿病高危患者的安全性：系统综述。

背景：由于诊断技术的改进以及社会经济地位较低的国家医疗条件的改善，1 型糖尿病（DM1）的发病率在全球范围内不断上升。一种新的抗 CD4 抗体--Tep-lizumab--已被证明可以延缓 DM1 的进展，并且是唯一获准用于该适应症的药物。目的：确定特普利珠单抗与安慰剂相比，基于系统的不良反应的几率比（OR）：方法：我们对从该药物问世至 2023 年 12 月 31 日期间的所有临床试验和研究进行了广泛的系统性回顾。所有对替普利珠单抗与安慰剂进行评估的临床试验和研究都纳入了初步审查。研究方案是根据《系统综述和元分析首选报告项目》指南设计的，并在 PROSPERO（ID：CRD42024496169）上进行了注册。使用 RevMan 软件 5.4 版生成粗略 OR：经过筛选和审查，选出了 5 项研究，以确定与安慰剂相比，替普利珠单抗的不良反应风险。共有 561 名患者被纳入研究人群。研究并报告了总的不良反应和基于系统的不良反应。我们发现，接受替普利珠单抗治疗的患者发生胃肠道（GI）（OR = 1.60，95%CI：1.01-2.52，P = 0.04）、皮肤（OR = 6.33，95%CI：4.05-9.88，P < 0.00001）和血液不良反应（OR = 19.03，95%CI：11.09-32.66，P < 0.00001）的风险较高。这些患者还很可能患有活动性 Epstein-Barr 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，与安慰剂相比，接受替普利珠单抗治疗的患者的总不良反应发生率确实更高，但这一结果并未达到统计学意义（OR = 2.25，95%CI：0.80-6.29，P = 0.12）：我们的系统综述表明，替普利珠单抗患者有发生严重不良反应的风险，主要与消化道、皮肤和血液系统有关。由于研究人群较小，不良反应的总数据有限。应该对这种药物进行更多的研究，以便更好地告知目标人群潜在的不良反应。

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来源期刊

World Journal of Diabetes ENDOCRINOLOGY & METABOLISM-

自引率

2.40%

发文量

909

期刊介绍： The WJD is a high-quality, peer reviewed, open-access journal. The primary task of WJD is to rapidly publish high-quality original articles, reviews, editorials, and case reports in the field of diabetes. In order to promote productive academic communication, the peer review process for the WJD is transparent; to this end, all published manuscripts are accompanied by the anonymized reviewers’ comments as well as the authors’ responses. The primary aims of the WJD are to improve diagnostic, therapeutic and preventive modalities and the skills of clinicians and to guide clinical practice in diabetes. Scope: Diabetes Complications, Experimental Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes, Gestational, Diabetic Angiopathies, Diabetic Cardiomyopathies, Diabetic Coma, Diabetic Ketoacidosis, Diabetic Nephropathies, Diabetic Neuropathies, Donohue Syndrome, Fetal Macrosomia, and Prediabetic State.