Wilson Aze, Choi Bethany, Sey Michael, Ponich Terry, Beaton Melanie, Kim Richard B
Divisions of Clinical Pharmacology, Department of Medicine, Western University, 339 A Wilson 339 Windermere Road A10-221a, London, ON, N6A 5A5, Canada.
Divisions of Gastroenterology, Department of Medicine, Western University, 339 Windermere Rd, London, ON, N6A 5A5, Canada.
BMC Gastroenterol. 2021 Feb 18;21(1):77. doi: 10.1186/s12876-021-01650-7.
The threshold concentration of infliximab during maintenance therapy has not been well-defined in relation to histologic remission. The aim of the study is to dentify the maintenance-phase infliximab concentration associated with histologic remission in inflammatory bowel disease patients (IBD).
A prospective cohort study was carried out in 104 IBD patients seen at a tertiary care centre in London, Canada. Infliximab trough concentrations were collected during the maintenance phase of treatment and compared between participants with and without evidence of histologic remission. Participants were additionally evaluated for sustained histologic remission, and relapse to active disease.
Participants in histologic remission attained higher mean concentrations of infliximab during the maintenance phase (10.34 ± 0.69 μg/ml) compared to those with persistent disease activity (6.23 ± 0.67 μg/ml, p-value < 0.0001). Additionally, during the maintenance phase, sustained histologic remission was also associated with a higher mean concentration of infliximab (10.81 ± 5.46 μg/ml) compared to those who relapsed to active disease (5.68 ± 3.70, p < 0.001). Overall, participants with a mean infliximab trough concentration greater than 8ug/ml were more likely to have histologic remission (area under the receiver operating characteristic curve, AUROC = 0.72, 95%CI = 0.65-0.84, p < 0.0001) and sustained histologic remission (AUC = 0.77, 95%CI = 0.63-0.91, p = 0.002).
Maintenance-phase infliximab trough concentrations greater than 8 μg/ml, which is higher than the currently recommended target concentration, are highly associated with histologic remission and sustained histologic remission.
在维持治疗期间，英夫利昔单抗的阈值浓度与组织学缓解之间的关系尚未明确界定。本研究的目的是确定炎症性肠病（IBD）患者中与组织学缓解相关的维持期英夫利昔单抗浓度。
在加拿大伦敦一家三级医疗中心对104例IBD患者进行了一项前瞻性队列研究。在治疗的维持阶段收集英夫利昔单抗谷浓度，并在有和没有组织学缓解证据的参与者之间进行比较。此外，对参与者进行持续组织学缓解和疾病复发至活动期的评估。
与疾病持续活动的参与者相比，组织学缓解的参与者在维持阶段达到了更高的英夫利昔单抗平均浓度（10.34±0.69μg/ml）（6.23±0.67μg/ml，p值<0.0001）。此外，在维持阶段，与复发至活动期的参与者相比，持续组织学缓解也与更高的英夫利昔单抗平均浓度相关（10.81±5.46μg/ml）（5.68±3.70，p<0.001）。总体而言，英夫利昔单抗谷平均浓度大于8μg/ml的参与者更有可能实现组织学缓解（受试者工作特征曲线下面积，AUROC=0.72，95%CI=0.65-0.84，p<0.0001）和持续组织学缓解（AUC=0.77，95%CI=0.63-0.91，p=0.002）。
维持期英夫利昔单抗谷浓度大于8μg/ml，高于目前推荐的目标浓度，与组织学缓解和持续组织学缓解高度相关。
