Liver MRI marker tied to lower quality of life in MASH, trial finds

Patients whose liver MRI scans showed greater disease activity reported worse health-related quality of life, independent of obesity, diabetes and other metabolic conditions, according to new results from the RADIcAL-1 randomized controlled trial conducted in Germany, the Netherlands, Portugal and the U.K.

‘Patients with MASH experience worse health-related quality of life: a multinational real-world study using LiverMultiScan,’ was conducted by a team of researchers including Marika Hancock, healthcare economist at Perscpectum Ltd.

Hancock and her team write in the study that the findings supply something economic models in metabolic dysfunction-associated steatotic liver disease (MASLD) have largely lacked, which is quality-of-life data measured directly in patients and linked to a noninvasive test, rather than assumed utility decrements.

How the RADIcAL-1 trial measured liver disease and quality of life

RADIcAL-1 enrolled 802 adults ages 18 to 75 with suspected MASLD at specialist liver centers in Ulm, Germany; Leiden, Netherlands; Coimbra, Portugal; and five U.K. cities. Patients were randomly assigned to standard of care or standard of care plus multiparametric MRI, which measures cT1, a marker of liver fibro-inflammation, and proton density fat fraction (PDFF), a measure of liver fat.

All participants completed the EQ-5D-5L, a patient-reported tool developed by the EuroQol Group to calculate health-related quality-adjusted life years (QALYs), at baseline and at two, six and 12 months. In the imaging arm, MASH was defined as cT1 of at least 800 milliseconds with PDFF of at least 10%, and high-risk MASH as cT1 of at least 875 milliseconds.

What the study found about MASH and quality of life

Quality of life did differ between the two study arms. Within the imaging arm, however, patients with MASH reported lower scores across all EQ-5D dimensions and on the companion EQ Visual Analogue Scale, a 0-to-100 rating of overall health, than patients with MASLD alone. The gap held after adjustment for comorbidities.

In a multivariable model adjusted for age, sex, liver fat, obesity, hypertension, hyperlipidemia, type 2 diabetes, other chronic disease and treatment status, each 80-millisecond rise in cT1 was linked to a 0.023-point decline in EQ-5D utility. Higher cT1 also raised the odds of reporting anxiety or depression problems by 29% and problems with usual activities by 46%.

Patients with high-risk MASH, who made up 31% of the cohort and represent the main target population for drug therapy, reported up to 12% more problems across EQ-5D domains than other patients, including 11.1% more mobility problems and 12% more impairment in usual activities. Those two differences were statistically significant.

Baseline utility ranged from 0.81 in Coimbra to 0.90 in Ulm. Portuguese patients, who had the highest rates of type 2 diabetes, hypertension and hyperlipidemia, reported the lowest quality of life at every time point. Even so, the association between cT1 and utility varied little from country to country.

“Collectively, these findings suggest that imaging biomarkers may capture clinically meaningful aspects of disease burden that extend beyond histological or biochemical abnormalities alone,” the authors wrote.

Why MASH quality-of-life data matters for payers

Health technology assessment bodies typically judge value by cost per QALY, and the authors noted that earlier models, including one that informed U.K. National Institute for Health and Care Excellence guidance on noninvasive liver testing, relied on assumed rather than measured utility values.

The data arrive as payers manage the first MASH-specific therapies. The FDA approved Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) as the first MASH treatment in 2024 and cleared Novo Nordisk’s Wegovy (semaglutide) for noncirrhotic MASH with moderate to advanced liver fibrosis in 2025.

The economic stakes are considerable. In the United States, it’s estimated that the economic burden of MASH will rise to $78.59 billion by 2040.