Real-world evidence in metabolic dysfunction-associated steatotic liver disease (MASLD): insights, challenges, and future directions

Abstract

Real-world evidence (RWE), derived from real-world data, offers key insights into metabolic dysfunction-associated steatotic liver disease (MASLD). RWE complements traditional randomised controlled trials by capturing large-scale, diverse patient populations and long-term outcomes. This review interrogates the role of RWE in understanding MASLD epidemiology, natural history, hepatic and extra-hepatic endpoints, including its co-morbid association with cardiovascular and chronic kidney disease, and its use in pharmacovigilance and precision medicine. RWE highlights large regional variations and is increasingly leveraged to advance drug development through target discovery and patient stratification. However, challenges such as data quality and confounding factors persist. In this review, key methodological gaps and future research priorities are identified and highlighted. The potential of artificial intelligence with multi-modal data linkage is considerable but requires rigorous methodologies and collaboration to fully realise the potential of RWE in MASLD research.