Di Domenicantonio Riccardo, Trotta Francesco, Cascini Silvia, Agabiti Nera, Kohn Anna, Gasbarrini Antonio, Davoli Marina, Addis Antonio
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
IBD Unit, AO San Camillo Forlanini, Rome, Italy.
Clin Epidemiol. 2018 Feb 5;10:203-213. doi: 10.2147/CLEP.S150030. eCollection 2018.
The comparison of effectiveness and safety of anti-tumor necrosis factor-alpha agents for the treatment of inflammatory bowel disease (IBD) is relevant for clinical practice and stakeholders.
The objective of this study was to compare the risk of abdominal surgery, steroid utilization, and hospitalization for infection in Crohn's disease (CD) or ulcerative colitis (UC) patients newly treated with infliximab (IFX) or adalimumab (ADA).
A retrospective population-based cohort study was performed using health information systems data from Lazio region, Italy. Patients with CD or UC diagnosis were enrolled at first prescription of IFX or ADA during 2008-2014 (index date). Only new drug users were followed for 2 years from the index date. IFX versus ADA adjusted hazard ratios were calculated applying "intention-to-treat" approach, controlling for several characteristics and stratifying the analysis on steroid use according to previous drug utilization. Sensitivity analyses were performed according to "as-treated" approach, adjusting for propensity score, censoring at switching or discontinuation, and evaluating different lengths of follow-up periods.
We enrolled 1,432 IBD patients (42% and 83% exposed to IFX for CD and UC, respectively). In both diseases, treatment effects did not differ in any outcome considered, and sensitivity analyses confirmed the results from the main analysis.
In our population-based cohort study, effectiveness and safety data in new users of ADA or IFX with CD or UC were comparable for the outcomes we tested.
比较抗肿瘤坏死因子-α药物治疗炎症性肠病（IBD）的有效性和安全性对临床实践及相关利益者具有重要意义。
本研究旨在比较初治克罗恩病（CD）或溃疡性结肠炎（UC）患者使用英夫利昔单抗（IFX）或阿达木单抗（ADA）后腹部手术风险、类固醇使用情况及感染住院情况。
利用意大利拉齐奥地区的健康信息系统数据进行一项基于人群的回顾性队列研究。2008年至2014年期间，CD或UC诊断患者在首次开具IFX或ADA处方时纳入研究（索引日期）。仅新用药患者从索引日期起随访2年。采用“意向性治疗”方法计算IFX与ADA的调整后风险比，控制多个特征，并根据既往用药情况对类固醇使用情况进行分层分析。根据“实际治疗”方法进行敏感性分析，调整倾向得分，在换药或停药时进行删失，并评估不同随访期。
我们纳入了1432例IBD患者（分别有42%和83%的CD和UC患者使用IFX）。在这两种疾病中，所考虑的任何结局的治疗效果均无差异，敏感性分析证实了主要分析结果。
在我们基于人群的队列研究中，CD或UC患者使用ADA或IFX新用户的有效性和安全性数据在所测试的结局方面具有可比性。
