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巴西克罗恩病患者的英夫利昔单抗及抗英夫利昔单抗抗体的血清水平。

Serum Levels of Infliximab and Anti-Infliximab Antibodies in Brazilian Patients with Crohn's Disease.

机构信息

Laboratorio de Investigacao em Doencas Inflamatorias Intestinais, Servico de Coloproctologia, Faculdade de Ciencias Medicas, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, BR.

Laboratorio de Sinalizacao Celular, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, BR.

出版信息

Clinics (Sao Paulo). 2019 Apr 8;74:e824. doi: 10.6061/clinics/2019/e824.

Abstract

OBJECTIVES

The aim of this study was to evaluate the quantitative serum level of infliximab (IFX) as well as the detection of anti-infliximab antibodies (ATIs) in patients with Crohn's disease (CD).

METHOD

Forty patients with CD under treatment at a tertiary center in southeastern Brazil were evaluated. Their use of infliximab was continuous and regular. We analyzed and compared the differences in the IFX and ATI levels between the patients with active CD (CDA) and those with CD in remission (CDR).

RESULTS

There was no difference in the IFX level between the CDA and CDR groups (p>0.05). Eighty percent of all patients had IFX levels above the therapeutic concentration (6-10 μg/mL). Two (9%) of the 22 patients with active disease and four (22.2%) of the 18 patients in remission had undetectable levels of IFX. Four (66.6%) of the six patients with undetectable levels of IFX had positive ATI levels; three of these patients were in remission, and one had active disease. In addition, the other two patients with undetectable levels of IFX presented ATI levels close to positivity (2.7 and 2.8 AU/ml). None of the patients with therapeutic or supratherapeutic IFX levels had positive ATI levels.

CONCLUSIONS

The undetectable levels of IFX correlated with the detection of ATIs, which was independent of disease activity. Immunogenicity was not the main factor for the loss of response to IFX in our study, and the majority of patients in both groups (CDA and CDR) had supratherapeutic levels of IFX.

摘要

目的

本研究旨在评估克罗恩病(CD)患者血清中英夫利昔单抗(IFX)的定量水平以及抗英夫利昔单抗抗体(ATIs)的检测情况。

方法

对巴西东南部一家三级中心接受治疗的 40 例 CD 患者进行评估。这些患者均持续、规律地使用英夫利昔单抗。我们分析并比较了活动期 CD(CDA)和缓解期 CD(CDR)患者之间 IFX 和 ATI 水平的差异。

结果

CDA 和 CDR 组之间的 IFX 水平无差异(p>0.05)。所有患者中有 80%的 IFX 水平超过治疗浓度(6-10μg/ml)。22 例活动期疾病患者中有 2 例(9%)和 18 例缓解期患者中有 4 例(22.2%)无法检测到 IFX 水平。6 例无法检测到 IFX 水平的患者中有 4 例(66.6%)存在阳性 ATI 水平;其中 3 例处于缓解期,1 例处于活动期。此外,另外 2 例无法检测到 IFX 的患者的 ATI 水平接近阳性(2.7 和 2.8 AU/ml)。没有任何治疗或超治疗 IFX 水平的患者出现阳性 ATI 水平。

结论

无法检测到 IFX 水平与 ATI 的检测相关,且与疾病活动无关。在我们的研究中,免疫原性不是导致对 IFX 失去反应的主要因素,而且两组(CDA 和 CDR)患者多数都具有超治疗 IFX 水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7ec/6445154/91945c376594/cln-74-e824-g001.jpg

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