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One-Year Changes in LSM by FibroScan® Device Predict Long-Term Liver Outcomes in Patients with MASLD: A Multicenter Cohort Study

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Study reference

Pennisi, et al. One-year Changes in Liver Stiffness Measurement, but not in Alanine Aminotransferase and Controlled Attenuation Parameter, Predict Long-term Liver Outcomes in Patients with Metabolic Dysfunction-associated Steatotic Liver Disease.

Background & objectives

With new drug treatments emerging for MASLD, there is an urgent clinical need for simple, widely available, non-invasive tools that can identify patients at risk of disease progression and monitor their response to therapy. This study evaluated whether 1-year changes in FibroScan®-derived data: liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), alongside FIB-4 and serum ALT, can predict liver-related outcomes in patients with MASLD and serve as practical non-invasive tools to guide and monitor pharmacological treatment decisions.

Methods

This multicenter retrospective cohort study enrolled MASLD patients between June 2008 and March 2023 across 16 centers in America, Europe, and Asia, including 1,744 patients with LSM ≥8 kPa and 989 with LSM ≥10 kPa, followed for a median of 28.2 and 32 months respectively. Liver-related events (LREs), including hepatocellular carcinoma (HCC) and liver decompensation (LD), were prospectively recorded, and LSM, CAP, ALT, and FIB-4 were assessed at both baseline and 1-year follow-up.

Results

  • LREs occurred in 39 patients with LSM ≥8 kPa and 35 with LSM ≥10 kPa; 1-year LSM variation was independently associated with LRE risk in both groups (HR 0.53; 95% CI 0.17–1; p=0.034 for LSM ≥8 kPa).

 

  • A 1-year % reduction in LSM independently predicted lower 3- and 5-year risk of LREs and liver decompensation (LD), but not hepatocellular carcinoma, across both LSM thresholds.

 

  • Patients with the greatest 1-year LSM reductions consistently showed the lowest hazard ratios for LREs and liver decompensation, while those with the largest increases faced the highest risk.

 

  • Baseline LSM was also independently associated with LRE development (HR 1.07; 95% CI 1.05–1.10; p<0.001), liver decompensation (HR 1.08; 95% CI 1.06–1.1; p<0.001), and HCC risk (HR 1.07; 95% CI 1.05–1.1; p<0.001).

 

  • Critically, 1-year changes in CAP, ALT, and FIB-4 were not independently associated with LREs, liver decompensation, or HCC in any analysis.

 

  • All findings were confirmed in the subgroup of patients with type 2 diabetes at both LSM thresholds, reinforcing the robustness of LSM variation as a prognostic marker in this high-risk population.

Take home messages

  • 1-year LSM reduction is the only non-invasive marker that predicts long-term liver outcomes in MASLD patients with LSM ≥8 kPa, with a 1-year decrease associated with a 47% reduction in LRE risk and 57% reduction in liver decompensation risk. Changes in CAP, ALT, and FIB-4 showed no such association.

 

  • The relationship between LSM change and prognosis is continuous, with no specific cutoff needed, greater reductions correspond to progressively lower risk of LREs and LD, while increases in LSM are linked to progressively higher risk.

 

  • These findings hold across higher-risk subgroups, including patients with LSM ≥10 kPa and those with type 2 diabetes, a population where reliable prognostic biomarkers have historically been lacking.

 

  • In a rapidly evolving therapeutic landscape, incorporating short-term LSM changes into routine follow-up could enable earlier recognition of treatment response, more individualized risk profiling, and better long-term disease management.

 

  • Expert panels already recommend considering 6-month or 1-year improvements in LSM as proof of treatment response, and our findings provide robust evidence to support this approach in clinical practice and future drug trials.

 

Serial liver stiffness measurements by FibroScan® device prove that what happens to liver stiffness at 1 year determines what happens to the liver over the long term — a 1-year reduction in LSM cuts the risk of liver-related events by 47% and liver decompensation by 57%, while increases predict progressively worse outcomes. As new MASLD drugs enter the market, this positions FibroScan® as the go-to non-invasive tool to monitor treatment response and guide the clinical decisions.

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