Veisman Ido, Barzilay Oranit, Bruckmayer Liora, Haj-Natour Ola, Kopylov Uri, Eliakim Rami, Ben-Horin Shomron, Ungar Bella
Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel.
J Clin Med. 2021 Sep 20;10(18):4265. doi: 10.3390/jcm10184265.
Infliximab and vedolizumab are effective treatments for inflammatory bowel disease (IBD), although associated with adverse events (AE). While low or non-existent drug levels and positive antidrug antibodies have been associated with therapeutic failure, there is no clear association between higher drug levels and AE. A cross-sectional study consisting of Crohn's disease (CD) and ulcerative colitis (UC) patients receiving infliximab or vedolizumab at the Sheba Medical Center was performed. Patients completed a questionnaire regarding AEs related to biological therapy. Serum trough levels obtained on the same day were analyzed. Objective measures of outcomes were retrieved from medical records. Questionnaires were completed by infliximab (n = 169) and vedolizumab (n = 88)-treated therapy patients. Higher infliximab levels were only numerically associated with the occurrence of at least one AE ( = 0.08). When excluding fatigue and abdominal pain, higher infliximab levels were statistically associated with the occurrence of at least one AE ( = 0.03). Vedolizumab drug levels > 18 μg/mL were also linked with the occurrence of more AEs. No specific association was observed between the increased levels of either infliximab or vedolizumab and specific AEs (neurological symptoms, upper GI symptoms, infectious complications, and musculoskeletal symptoms). As significant AEs are very rare, additional multi-center studies are required.
英夫利昔单抗和维多珠单抗是治疗炎症性肠病（IBD）的有效药物，尽管会伴有不良事件（AE）。虽然药物水平低或不存在以及抗药抗体阳性与治疗失败有关，但较高的药物水平与不良事件之间没有明确的关联。在舍巴医疗中心进行了一项横断面研究，研究对象为接受英夫利昔单抗或维多珠单抗治疗的克罗恩病（CD）和溃疡性结肠炎（UC）患者。患者完成了一份关于生物治疗相关不良事件的问卷。分析了同一天获得的血清谷浓度。从病历中获取结局的客观测量指标。问卷由接受英夫利昔单抗治疗的169例患者和接受维多珠单抗治疗的88例患者完成。较高的英夫利昔单抗水平仅在数值上与至少发生一次不良事件相关（P = 0.08）。排除疲劳和腹痛后，较高的英夫利昔单抗水平与至少发生一次不良事件在统计学上相关（P = 0.03）。维多珠单抗药物水平>18μg/mL也与更多不良事件的发生有关。未观察到英夫利昔单抗或维多珠单抗水平升高与特定不良事件（神经症状、上消化道症状、感染并发症和肌肉骨骼症状）之间存在特定关联。由于严重不良事件非常罕见，因此需要进行更多的多中心研究。
