Barberio Brigida, Savarino Edoardo Vincenzo, Card Timothy, Canova Cristina, Baldisser Francesco, Gubbiotti Alessandro, Massimi Davide, Ghisa Matteo, Zingone Fabiana
Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.
Intest Res. 2022 Jan;20(1):114-123. doi: 10.5217/ir.2021.00037. Epub 2021 Aug 4.
BACKGROUND/AIMS: Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.
A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).
VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.
背景/目的：目前的文献缺乏在实际临床场景中比较接受阿达木单抗（ADA）或维多珠单抗（VDZ）治疗的炎症性肠病（IBD）患者不良事件（AE）发生率的研究。因此，我们的主要目的是比较服用ADA的患者与服用VDZ的患者发生的AE。
在这项单中心研究中，回顾性收集了接受ADA和VDZ治疗的IBD患者的AE数据。计算每100人年的AE发生率。使用Cox回归模型估计两种药物之间AE的风险比。
在研究期间，共有16例ADA患者（17.2%）和11例VDZ患者（7.6%）发生导致药物中断的AE（P=0.02）。大多数AE为非感染性肠外事件（ADA组为50%，VDZ组为54.5%），而感染在接受ADA治疗的患者的AE中占31.2%，在接受VDZ治疗的患者中占27.3%。导致治疗停药的AE发生率，ADA为每100人年13.2例，VDZ为每100人年5.3例，这表明VDZ患者的风险降低了76%。考虑治疗的第一年，我们观察到34例接受ADA治疗的患者（36.5%）至少发生1次AE，服用VDZ的患者中有57例（39.3%）发生AE（P=0.67）。
与ADA相比，VDZ导致停药的AE发生率较低，但不导致药物中断的AE风险相似。仍需要进行实际的直接比较研究，以进一步探索这些药物的安全性。
