A new generation of non-invasive tests of liver fibrosis with improved accuracy in MASLD

IF 26.8 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Journal of Hepatology Pub Date : 2024-12-13 DOI:10.1016/j.jhep.2024.11.049

Paul Calès, Clémence M. Canivet, Charlotte Costentin, Adrien Lannes, Frédéric Oberti, Isabelle Fouchard, Gilles Hunault, Victor de Lédinghen, Jérôme Boursier

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引用次数: 0

Abstract

Background & aims

The accuracy of non-invasive tests (NITs) should be ≥80% (EASL recommendation). We aimed to compare the accuracies of the recommended NITs for advanced fibrosis in MASLD and improve NIT accuracy.

Methods

1051 MASLD patients were allocated to derivation (n=637) and validation (n=414) sets. The main outcome (Kleiner F3+F4) was primarily evaluated by accuracy. Conventional NITs were FIB-4, Fibrotest, FibroMeter, liver stiffness measurement (LSM by Fibroscan), Elasto-FibroMeter (FibroMeter-LSM combination), and ELF in 396 patients. We used machine-learning-optimized multitargeting to develop new NITs: FIB-9 (including 9 usual biomarkers), FIB-11 (adding 2 specialized blood markers) and FIB-12 (adding LSM).

Results

In the whole population, the accuracies of recommended NITs were insufficient, Fibrotest: 68.0%, FIB-4: 71.2%, FibroMeter: 75.1%, LSM: 75.9%, Elasto-FibroMeter: 78.6%. Therefore, new NITs (FIB-9, FIB-11, FIB-12) were developed in the derivation set. In the validation set, AUROCs were, FIB-4: 0.757, Fibrotest: 0.766, FibroMeter: 0.850, LSM: 0.852, FIB-9: 0.863, FIB-11: 0.880, Elasto-FibroMeter: 0.894, FIB-12: 0.912 (p<0.001). The FIB-12 AUROC was superior to the ELF AUROC (0.906 vs 0.865, p=0.039). Accuracies were, FIB-4: 68.8%, Fibrotest: 68.6%, LSM: 75.4%, FibroMeter: 76.3%, FIB-9: 78.7%, Elasto-FibroMeter: 79.7%, FIB-11: 80.2%, FIB-12: 83.3% (p<0.001 between all NITs). Scores were segmented by ≥90% sensitivity and specificity cut-offs or NIT match, which individualized subgroups with NIT accuracies ≥80%, e.g. for FIB-9: 85.8% in 68.1% of patients using two cut-offs and 83.2% in 71.7% of patients where FIB-9 agreed with FIB-4.

Conclusions

Recommended NITs had accuracies <80% for advanced fibrosis in MASLD. Several NIT segmentations individualized subgroups with accuracies ≥80%. New NITs further improved accuracy. The simple FIB-9 (available via a free calculator) provided accuracy equaling or surpassing recommended NITs. FIB-12 outperformed other NITs.

Impact and implications

Currently recommended non-invasive tests (NITs) have insufficient accuracy (<80%) for the diagnosis of advanced fibrosis in MASLD. Therefore, we developed three new NITs with new statistical techniques. Thus, FIB-9 (available via a free calculator), including nine usual blood markers, equaled the performance of patented NITs. FIB-11, adding two specialized blood markers, and FIB-12, adding liver stiffness, had accuracy >80%. FIB-12, outperformed all other NITs. FIB-9 is suitable for screening and FIB-11 or FIB-12 for diagnosis.

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新一代无创肝纤维化检测提高了MASLD的准确性

背景,目的无创检查（NITs）的准确性应≥80% （EASL推荐）。我们的目的是比较推荐的NIT对MASLD晚期纤维化的准确性，并提高NIT的准确性。方法将1051例MASLD患者分为衍生组（n=637）和验证组（n=414）。主要结局（Kleiner F3+F4）主要以准确性评价。396例患者的常规NITs包括FIB-4、Fibrotest、FibroMeter、肝硬度测量（通过Fibroscan进行的LSM）、Elasto-FibroMeter （FibroMeter-LSM联合）和ELF。我们使用机器学习优化的多靶向技术开发了新的nit: FIB-9（包括9种常见的生物标志物），FIB-11（添加2种专门的血液标志物）和FIB-12（添加LSM）。结果在全人群中，推荐的nit的准确率为Fibrotest: 68.0%, FIB-4: 71.2%, FibroMeter: 75.1%, LSM: 75.9%, Elasto-FibroMeter: 78.6%。因此，在派生集中开发了新的nit （FIB-9、FIB-11、FIB-12）。在验证集中，auroc为：FIB-4: 0.757, Fibrotest: 0.766, FibroMeter: 0.850, LSM: 0.852, FIB-9: 0.863, FIB-11: 0.880, Elasto-FibroMeter: 0.894, FIB-12: 0.912 （p<0.001）。FIB-12 AUROC优于ELF AUROC （0.906 vs 0.865, p=0.039）。准确度为：FIB-4: 68.8%, Fibrotest: 68.6%, LSM: 75.4%, FibroMeter: 76.3%, FIB-9: 78.7%, Elasto-FibroMeter: 79.7%, FIB-11: 80.2%, FIB-12: 83.3%（所有nit之间的差异为0.001）。评分以≥90%的敏感性和特异性临界值或NIT匹配度进行分割，其中NIT准确率≥80%的个体亚组，例如对于FIB-9: 68.1%的患者使用两个临界值为85.8%，71.7%的患者使用两个临界值为83.2%，其中FIB-9符合FIB-4。结论：推荐的NITs治疗MASLD晚期纤维化的准确率为80%。几个NIT分割个性化亚组，准确率≥80%。新的NITs进一步提高了准确性。简单的FIB-9（可通过免费计算器获得）提供的准确度等于或超过推荐的nit。FIB-12的表现优于其他nit。影响和意义目前推荐的非侵入性检查（NITs）在诊断MASLD晚期纤维化方面准确性不足（80%）。因此，我们利用新的统计技术开发了三个新的nit。因此，FIB-9（可通过免费计算器获得），包括9种常见的血液标记物，与专利nit的性能相当。FIB-11添加了两种专门的血液标记物，FIB-12添加了肝脏硬度，准确率为80%。FIB-12的表现优于所有其他nit。FIB-9适用于筛查，FIB-11或FIB-12适用于诊断。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Hepatology 医学-胃肠肝病学

CiteScore

46.10

自引率

4.30%

发文量

2325

审稿时长

30 days

期刊介绍： The Journal of Hepatology is the official publication of the European Association for the Study of the Liver (EASL). It is dedicated to presenting clinical and basic research in the field of hepatology through original papers, reviews, case reports, and letters to the Editor. The Journal is published in English and may consider supplements that pass an editorial review.