Non-invasive scores have been proposed to identify patients with fibrotic, metabolic dysfunction-associated steatohepatitis (MASH), who are at the highest risk of progression to complications of cirrhosis and may benefit from pharmacologic treatments. However, data in patients with type 2 diabetes (T2DM) are lacking. The aim of this multicenter prospective study was to perform a head-to-head comparison of FAST (FibroScan-aspartate aminotransferase [AST]), MAST (MRI-AST), MEFIB (magnetic resonance elastography [MRE] plus FIB-4), and FNI (fibrotic NASH index) for detecting fibrotic MASH in patients with T2DM. A total of 330 outpatients with T2DM and biopsy-proven metabolic dysfunction-associated steatotic liver disease (MASLD) from the QUID-NASH study (NCT03634098), who underwent FibroScan, MRI-proton density fat fraction and MRE at the time of liver biopsy were studied. The main outcome was fibrotic MASH, defined as NAS ≥4 (with at least one point for each parameter) and fibrosis stage ≥2 (centrally reviewed). All data for score comparisons were available for 245 patients (median age 59 years, 65% male, median BMI 31 kg/m; fibrotic MASH in 39%). FAST and MAST had similar accuracy (AUROCs 0.81 0.79, 0.41) but outperformed FNI (0.74; 0.01) and MEFIB (0.68; <0.0001). When using original cut-offs, MAST outperformed FAST, MEFIB and FNI when comparing the percentage of correctly classified patients, in whom liver biopsy would be avoided (69% 48%, 46%, 39%, respectively; <0.001). When using cut-offs specific to our population, FAST outperformed FNI and MAST (56% 40%, and 38%, respectively; <0.001). Our findings show that FAST, MAST, MEFIB and FNI are accurate non-invasive tools to identify patients with T2DM and fibrotic MASH in secondary/tertiary diabetes clinics. Cut-offs adapted to the T2DM population should be considered. Among patients with type 2 diabetes (T2DM), identifying those with metabolic dysfunction-associated steatohepatitis and significant fibrosis, who are the most at risk of developing clinical liver-related outcomes and who may benefit from pharmacologic treatments, is an unmet need. In this prospective multicenter study, we compared four non-invasive scores, three based on imaging (MRI or ultrasound technologies) and one on laboratory blood tests, for this purpose, using original and study-specific cut-offs. Our findings show that FAST, MAST, MEFIB and FNI are accurate non-invasive tools to identify patients with T2DM and fibrotic MASH in secondary/tertiary diabetes clinics. Cut-offs adapted to the T2DM population should be considered. NCT03634098.

中文翻译：

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用于诊断 2 型糖尿病患者纤维化 MASH 的无创评分的前瞻性头对头比较


已提出无创评分来识别患有纤维化、代谢功能障碍相关脂肪性肝炎 (MASH) 的患者，这些患者进展为肝硬化并发症的风险最高，可能会受益于药物治疗。然而，缺乏 2 型糖尿病 (T2DM) 患者的数据。这项多中心前瞻性研究的目的是对 FAST（FibroScan-天冬氨酸转氨酶 [AST]）、MAST (MRI-AST)、MEFIB（磁共振弹性成像 [MRE] 加 FIB-4）、 FNI（纤维化 NASH 指数）用于检测 T2DM 患者的纤维化 MASH。共有 330 名来自 QUID-NASH 研究 (NCT03634098) 的 T2DM 门诊患者和活检证实的代谢功能障碍相关脂肪肝病 (MASLD)，他们在肝活检时接受了 FibroScan、MRI 质子密度脂肪分数和 MRE研究过。主要结局是纤维化 MASH，定义为 NAS ≥4（每个参数至少 1 分）和纤维化阶段 ≥2（集中审查）。所有评分比较数据均适用于 245 名患者（中位年龄 59 岁，65% 为男性，中位 BMI 31 kg/m；纤维化 MASH 占 39%）。 FAST 和 MAST 具有相似的准确度（AUROC 0.81 0.79，0.41），但优于 FNI（0.74；0.01）和 MEFIB（0.68；<0.0001）。当使用原始临界值时，在比较正确分类的患者的百分比时，MAST 优于 FAST、MEFIB 和 FNI，其中避免肝活检（分别为 69%、48%、46%、39%；<0.001）。当使用特定于我们人群的截止值时，FAST 优于 FNI 和 MAST（分别为 56%、40% 和 38%；<0.001）。我们的研究结果表明，FAST、MAST、MEFIB 和 FNI 是准确的非侵入性工具，可在二期/三期糖尿病诊所中识别 T2DM 和纤维化 MASH 患者。 应考虑适应 T2DM 人群的截止值。在 2 型糖尿病 (T2DM) 患者中，识别患有代谢功能障碍相关脂肪性肝炎和显着纤维化的患者是一项未得到满足的需求，他们最有可能出现临床肝脏相关结果，并且可能从药物治疗中受益。在这项前瞻性多中心研究中，我们使用原始的和研究特定的截止值，比较了四种非侵入性评分，其中三种基于成像（MRI 或超声技术），一种基于实验室血液测试。我们的研究结果表明，FAST、MAST、MEFIB 和 FNI 是准确的非侵入性工具，可在二期/三期糖尿病诊所中识别 T2DM 和纤维化 MASH 患者。应考虑适应 T2DM 人群的截止值。 NCT03634098。