Krajcovicova A, Batovsky M, Gregus M, Hlista M, Durina J, Leskova Z, Sturdik I, Gojdic M, Jalali Y, Koller T, Toth J, Huorka M, Hlavaty T
Comenius University, Faculty of Medicine, 5th department of Internal Medicine, University Hospital, Bratislava, Slovak republic.
Clinic of Gastroenterology, University Hospital Bratislava, Slovak republic.
Acta Gastroenterol Belg. 2018 Oct-Dec;81(4):465-470.
The aim of the study was to identify factors influencing infliximab (IFX) trough levels (TL) in patients with inflammatory bowel disease (IBD).
This was a multicentre cross-sectional study performed at 5 large IBD centres in Slovakia. The cohort consisted of IBD patients, treated either with original IFX or CT-P13 biosimilar, who were examined for the IFX TL and antidrug antibodies (ADA) in a central laboratory.
The patient cohort consisted of 116 consecutive IBD patients, 68 with Crohn's disease (CD) and 48 with ulcerative colitis (UC). CD patients had significantly lower IFX TL compared to UC, 2.41 (0.998-5.56) mg/L vs. 4.49 (1.76-8.41) mg/L, p = 0.017. During maintenance treatment, significantly higher mean IFX TL were observed in patients with a 4 week dosing interval than in patients with a 6 or 8 (7.44±3.6 μg/mL vs. 4.19±4.2 vs. 3.30±3.1 μg/mL, p = 0.011 and p< 0.0001, respectively). There was no difference in median TL IFX between original IFX and biosimilar CT-P13 (3.25 (1.24-6.52) mg/L vs. 3.03 (1.30-7.10)). IFX TL correlated with ADA (p=0.005). Multiple regression analysis revealed two independent factors for IFX TL: dosing interval (p<0.0001) and diagnosis (p=0.02).
In the present study we observed that IBD patients assigned to an intensified dosing interval during maintenance therapy have significantly higher IFX TL than patients receiving conventional 8 week interval. Patients with UC had significantly higher IFX TL.
本研究旨在确定影响炎症性肠病（IBD）患者英夫利昔单抗（IFX）谷浓度（TL）的因素。
这是一项在斯洛伐克5个大型IBD中心进行的多中心横断面研究。该队列由接受原研IFX或CT-P13生物类似药治疗的IBD患者组成，他们在中央实验室接受IFX TL和抗药抗体（ADA）检测。
患者队列包括116例连续的IBD患者，其中68例为克罗恩病（CD）患者，48例为溃疡性结肠炎（UC）患者。与UC患者相比，CD患者的IFX TL显著更低，分别为2.41（0.998 - 5.56）mg/L和4.49（1.76 - 8.41）mg/L，p = 0.017。在维持治疗期间，给药间隔为4周的患者观察到的平均IFX TL显著高于给药间隔为6周或8周的患者（分别为7.44±3.6 μg/mL对4.19±4.2对3.30±3.1 μg/mL，p = 0.011和p < 0.0001）。原研IFX和生物类似药CT-P13之间的IFX TL中位数无差异（3.25（1.24 - 6.52）mg/L对3.03（1.30 - 7.10））。IFX TL与ADA相关（p = 0.005）。多元回归分析揭示了影响IFX TL的两个独立因素：给药间隔（p < 0.0001）和诊断（p = 0.02）。
在本研究中，我们观察到在维持治疗期间被分配到强化给药间隔的IBD患者的IFX TL显著高于接受传统8周给药间隔的患者。UC患者的IFX TL显著更高。
