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

作　　者：Venkata Buddhavarapu Gagandeep Dhillon Harpreet Grewal Pranjal Sharma Rahul Kashyap Salim Surani 

机构地区：[1]Department of Medicine,Banner Baywood Medical Center,Banner Health,Mesa,AZ 85206,United States [2]Department of Medicine,UM Baltimore Washington Medical Center,Glen Burnie,MD 21061,United States [3]Department of Radiology,Ascension Sacred Heart Hospital,Pensacola,FL 32504,United States [4]Department of Medicine,Northeast Ohio Medical Center,Rootstown,OH 44272,United States [5]Department of Research,Wellspan Health,York,PA 17403,United States [6]Anesthesiology,Mayo Clinic,Rochester,MN 55905,United States [7]Department of Medicine&Pharmacology,Texas A&M University,College Station,TX 77843,United States

出　　处：《World Journal of Diabetes》2024年第8期1793-1801,共9页世界糖尿病杂志（英文版）（电子版）

摘　　要：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,Teplizumab,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 li

关 键 词：Teplizumab Diabetes mellitus type 1 Adverse effects Monoclonal antibody Systematic review 

分 类 号：R587.1[医药卫生—内分泌]