Assessment of the Real-World Safety Profile of Vedolizumab Using the United States Food and Drug Administration Adverse Event Reporting System

For two decades the standard drug therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) has been anti-tumor necrosis factor agents (anti-TNFs) such as adalimumab (Humira), certolizumab pegol (Cimzia), infliximab (Remicade) and several others. More recently, vedolizumab (Entyvio) has entered the market as the first gut-selective integrin blocker that offers an alternative treatment for inflammatory bowel disease (IBD). Using the FDA Adverse Event Reporting System (FAERS) database, this study compared adverse event reports (AE) for the two types of therapies. The search retrieved 499 reports for vedolizumab and 119,620 for anti-TNFs for the years 1998 through 2015. Using the proportional reporting ratio (PPR) and the empirical Bayesian geometric mean (EBGM) algorithms, AE data were reviewed for signals of disproportionate reporting for the two types of drugs. This dataset includes statistical summary tables of characteristics (demographic) and a variety of adverse event comparisons of vedolizumab, anti-TNFs, and all other medications. Cleaned FAERS data was provided with permission by DrugLogic, Inc. Interested researchers may contact DrugLogic Inc. (Reston, VA) by calling 800-393-1313 or emailing [e-mail]

在过去的二十年间，针对克罗恩病（CD）和溃疡性结肠炎（UC）患者的标准药物治疗方案一直为抗肿瘤坏死因子（anti-TNFs）类药物，如阿达木单抗（Humira）、塞托利珠单抗聚乙二醇（Cimzia）、英夫利昔单抗（Remicade）以及其他数种药物。近期，维多利珠单抗（Entyvio）作为一种新型的针对肠道选择的整合素阻断剂，为炎症性肠病（IBD）的治疗提供了替代方案。本研究利用美国食品药品监督管理局（FDA）的不良事件报告系统（FAERS）数据库，对比了两种治疗方案的不良事件报告（AE）。搜索结果显示，从1998年至2015年，维多利珠单抗有499份报告，而抗TNFs有119,620份报告。通过使用比例报告比率（PPR）和经验贝叶斯几何均值（EBGM）算法，对AE数据进行了审查，以寻找两种药物类型报告不平衡的信号。本数据集包括维多利珠单抗、抗TNFs以及其他所有药物的各种不良事件的统计总结表格。在DrugLogic, Inc.（弗吉尼亚州雷斯顿）的许可下，提供了清洁的FAERS数据。有兴趣的研究人员可以通过拨打800-393-1313或发送邮件至[e-mail]联系DrugLogic Inc.。