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希腊三级中心的一项横断面研究:炎症性肠病患者英夫利昔单抗谷浓度与英夫利昔单抗治疗升级的相关性

Infliximab trough levels among patients with inflammatory bowel disease in correlation with infliximab treatment escalation: a cross-sectional study from a Greek tertiary center.

作者信息

Orfanidou Afroditi, Katsanos Konstantinos, Voulgaris Theodoros, Kofinas Aristeidis, Christodoulou Maria Veatriki, Konstandi Maria, Christodoulou Dimitrios

机构信息

Department of Gastroenterology, University General Hospital of Ioannina, University of Ioannina (Afroditi Orfanidou, Konstantinos Katsanos, Dimitrios Christodoulou).

Endoscopic Unit, 2 Department of Surgery, Aretaieion University Hospital, Athens (Theodoros Voulgaris).

出版信息

Ann Gastroenterol. 2024 Nov-Dec;37(6):674-681. doi: 10.20524/aog.2024.0926. Epub 2024 Oct 31.

Abstract

BACKGROUND

Infliximab monitoring correlates with improved outcomes in inflammatory bowel disease (IBD). We aimed to evaluate the association between serum infliximab trough levels (TLs) and therapeutic outcomes in Greek patients with Crohn's disease (CD) or ulcerative colitis (UC).

METHODS

This cross-sectional study included consecutive adult patients with IBD receiving intravenous infliximab maintenance therapy at a Greek tertiary center. Therapeutic outcomes assessed were clinical remission (CR), steroid-free clinical remission (SFCR), biochemical remission (BR: C-reactive protein <5 mg/L), and combined (steroid-free and biochemical) remission (SFCBR).

RESULTS

Seventy-seven patients participated (62.3% with CD, 16.8% on concomitant immunomodulators), with a mean infliximab infusion duration of 5.1±4.6 years. Forty-seven (61%) patients underwent treatment escalation. Infliximab mean TLs were 7.2±4.9 μg/mL, correlating only with treatment escalation (9.7 vs. 3.6 μg/mL, P<0.001). CR was achieved in 88.3% of patients, SFCR in 80.5%, BR in 62.3%, and SFCBR in 55.8%. In a subgroup analysis, for patients without treatment escalation, higher mean TLs were significantly associated with BR (4.2 vs. 0.8 μg/mL, P=0.020) and SFCBR (4.3 vs. 1.5 μg/mL, P=0.035). In receiver operating characteristic analysis, TLs predicted SFCBR (P=0.016) with good accuracy (area under the curve [AUC] 0.768, 95% confidence interval [CI] 0.584-0.952), with an optimal TL cutoff at 3.4 μg/mL. For patients with treatment escalation, TLs predicted SFCBR (P=0.018) with fair accuracy (AUC 0.653, 95%CI 0.527-0.755), with an optimal TL cutoff at 11 μg/mL.

CONCLUSIONS

Infliximab TLs correlate with treatment escalation. Higher infliximab TLs may predict combined remission among patients with treatment escalation.

摘要

背景

英夫利昔单抗监测与炎症性肠病(IBD)改善的预后相关。我们旨在评估希腊克罗恩病(CD)或溃疡性结肠炎(UC)患者血清英夫利昔单抗谷浓度(TLs)与治疗结局之间的关联。

方法

这项横断面研究纳入了在希腊一家三级中心接受静脉注射英夫利昔单抗维持治疗的连续性成年IBD患者。评估的治疗结局包括临床缓解(CR)、无类固醇临床缓解(SFCR)、生化缓解(BR:C反应蛋白<5mg/L)以及联合(无类固醇和生化)缓解(SFCBR)。

结果

77例患者参与研究(62.3%为CD患者,16.8%同时使用免疫调节剂),英夫利昔单抗平均输注时间为5.1±4.6年。47例(61%)患者接受了治疗升级。英夫利昔单抗平均TLs为7.2±4.9μg/mL,仅与治疗升级相关(9.7 vs. 3.6μg/mL,P<0.001)。88.3%的患者实现了CR,80.5%实现了SFCR,62.3%实现了BR,55.8%实现了SFCBR。在亚组分析中,对于未进行治疗升级的患者,较高的平均TLs与BR(4.2 vs. 0.8μg/mL,P=0.020)和SFCBR(4.3 vs. 1.5μg/mL,P=0.035)显著相关。在受试者工作特征分析中,TLs预测SFCBR(P=0.016)具有良好的准确性(曲线下面积[AUC]为0.768,95%置信区间[CI]为0.584 - 0.952),最佳TL临界值为3.4μg/mL。对于进行治疗升级的患者,TLs预测SFCBR(P=0.018)具有中等准确性(AUC为0.653,95%CI为0.527 - 0.755),最佳TL临界值为11μg/mL。

结论

英夫利昔单抗TLs与治疗升级相关。较高的英夫利昔单抗TLs可能预测治疗升级患者的联合缓解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b69/11574158/3623c0c11858/AnnGastroenterol-37-674-g003.jpg

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