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英夫利昔单抗治疗药物浓度监测对炎症性肠病患者结局的影响:来自中东队列的真实世界经验。

Impact of infliximab therapeutic drug level monitoring on outcomes of patients with inflammatory bowel disease: A real-world experience from a Middle Eastern cohort.

机构信息

Division of Gastroenterology, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.

Division of Gastroenterology, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.

出版信息

Arab J Gastroenterol. 2021 Mar;22(1):66-72. doi: 10.1016/j.ajg.2021.01.001. Epub 2021 Feb 23.

DOI:10.1016/j.ajg.2021.01.001
PMID:33632623
Abstract

BACKGROUND AND STUDY AIM

Therapeutic drug monitoring (TDM) through measurement of infliximab (IFX) trough levels and antibodies to infliximab (ATI) is performed to guide IFX intensification strategies and improve its efficacy. We conducted this study to explore the relationship between clinical and endoscopic/radiological remission and IFX and ATI levels in patients with inflammatory bowel disease (IBD) treated with IFX and to evaluate the appropriateness of treatment decision post TDM.

PATIENTS AND METHODS

This was a cross-sectional study of a cohort of adult patients with IBD. Serum IFX trough concentrations and ATI were measured.

RESULTS

A total of 129 patients [104] with ulcerative colitis (UC) and 25 with Crohn's disease (CD)] were included in this study, of whom 61.2% were men. The mean disease duration was 6.7 years, and 72% of patients with UC had extensive colitis. The mean serum IFX trough level was 4.1 µg/mL; the IFX trough levels were subtherapeutic in 75 patients (58%), therapeutic in 37 patients (29%), and supratherapeutic in 17 patients (13%). Positivity to ATI was found in 16 patients (12.4%). Only 43 patients (33.3%) underwent an appropriate change in therapy after TDM, patients with penetrating CD disease had low IFX levels and higher C-reactive protein levels at 12 months before TDM.

CONCLUSIONS

Patients with IBD with therapeutic IFX levels tend to have increased endoscopic/radiological remission rates. However, an appropriate change in management based on TDM was absent in the majority of patients, potentially reflecting the need to have a dashboard to support and guide clinicians in decision-making.

摘要

背景和研究目的

通过测量英夫利昔单抗(IFX)的谷浓度和抗英夫利昔单抗(ATI)来进行治疗药物监测(TDM),以指导 IFX 强化策略并提高其疗效。我们进行这项研究旨在探讨接受 IFX 治疗的炎症性肠病(IBD)患者的临床和内镜/影像学缓解与 IFX 和 ATI 水平之间的关系,并评估 TDM 后治疗决策的恰当性。

患者和方法

这是一项对 IBD 成年患者队列进行的横断面研究。测量血清 IFX 谷浓度和 ATI。

结果

本研究共纳入 129 例[104 例溃疡性结肠炎(UC)和 25 例克罗恩病(CD)]患者,其中 61.2%为男性。平均疾病病程为 6.7 年,72%的 UC 患者为广泛性结肠炎。平均血清 IFX 谷浓度为 4.1µg/mL;75 例患者(58%)IFX 谷浓度低于治疗范围,37 例(29%)处于治疗范围内,17 例(13%)高于治疗范围。16 例(12.4%)患者 ATI 阳性。仅 43 例(33.3%)患者在 TDM 后进行了适当的治疗改变,TDM 前 12 个月,穿透性 CD 疾病患者的 IFX 水平较低,C 反应蛋白水平较高。

结论

IBD 患者 IFX 水平处于治疗范围内时,内镜/影像学缓解率较高。然而,大多数患者未根据 TDM 进行适当的治疗改变,这可能反映出需要一个仪表盘来支持和指导临床医生进行决策。

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