Target RWE, a leader in real-world evidence generation for complex diseases, presented groundbreaking research on liver diseases at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, Netherlands. The company shared critical findings on Metabolic dysfunction-Associated SteatoHepatitis (MASH), Hepatocellular Carcinoma (HCC), and contributed expert leadership to the Primary Biliary Cholangitis (PBC) Consensus Conference.
Significant Findings on MASH and Diabetes
One of the most notable presentations from Target RWE revealed that patients with MASH and Type 2 diabetes face significantly higher risks of progressing to compensated cirrhosis compared to those without diabetes. This finding, derived from the TARGET-NASH cohort, underscores the urgent need for early MASH screening in diabetic populations.
"Our MASH study underscores the significant impact of type 2 diabetes on disease progression, emphasizing the urgent need for proactive screening and management strategies to prevent the development of advanced liver disease in this high-risk population," stated a Target RWE representative.
The research provides valuable insights for clinicians managing patients with both conditions and highlights potential intervention points to prevent disease progression.
Advancing HCC Treatment Understanding
Target RWE also presented comprehensive analysis of treatment patterns and outcomes for HCC patients undergoing transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) from the TARGET-HCC registry.
The analysis revealed heterogeneous treatment patterns and outcomes in intermediate or advanced HCC patients, with concerning findings including high rates of TACE/TARE unsuitability and low rates of subsequent systemic therapy use. These insights illuminate challenges clinicians face in optimizing therapy sequences and identify opportunities to improve adherence to treatment guidelines.
Leadership in PBC Research
Further establishing its position as a leader in hepatology research, Target RWE's Co-Founder and Chief Medical Officer, Michael W. Fried, MD, FAASLD, participated in the PBC Consensus Conference on May 6, 2025. This pre-congress event focused on surrogate endpoints and real-world evidence in Primary Biliary Cholangitis research.
"Participating in this consensus conference offers a unique opportunity to collaborate with leading experts in refining endpoints and integrating real-world data into PBC research," said Dr. Fried. "Aligning these priorities is essential for advancing therapeutic development and enhancing patient outcomes."
The conference served as a critical platform for harmonizing research methodologies and ensuring clinical trials reflect real-world patient experiences, ultimately guiding the future of PBC therapy development.
Regulatory Landscape and Evidence Generation
With regulatory agencies increasingly requiring early, comprehensive evidence—especially in MASH and PBC—Target RWE's real-world insights are positioned to support biopharmaceutical companies in navigating complex development decisions. The company's approach enables stakeholders to:
- Identify MASH patients without invasive biopsies in clinical trials
- Assess long-term outcomes and therapy patterns in PBC patients unresponsive to ursodeoxycholic acid (UDCA)
- Understand the impact of comorbidities on MASH treatment efficacy
- Integrate patient perspectives on quality of life and treatment satisfaction
TARGET-Liver Disease Study Reaches Major Milestone
Target RWE recently announced a significant enrollment milestone of over 600,000 patients in its TARGET-Liver Disease (LD) observational study. This study, conducted in partnership with the American Association for the Study of Liver Diseases (AASLD) to support the Cirrhosis Quality Collaborative (CQC), collects patient data from more than 75 U.S. healthcare facilities.
"Since the launch of our partnership with AASLD/CQC, the TARGET-LD real-world study has made remarkable progress in enrolling more than 600,000 patients affected by liver diseases, including MASLD and cirrhosis," said Dr. Fried. "We are honored to continue strengthening our partnership with AASLD and the CQC to develop actionable insights that can positively impact the increasing challenges that healthcare systems and providers face."
W. Ray Kim, MD, MBA, FAASLD, AASLD President and Professor of Medicine at Mayo Clinic Arizona, emphasized the importance of this collaboration: "CQC/Target RWE is an important element in our current strategic priority to advance scientific leadership in liver disease. Despite ground-breaking innovations in the treatment of various liver diseases, such as hepatitis B, hepatitis C and liver transplantation, the number of Americans succumbing from chronic liver disease has continued to rise in the past two decades."
Future Directions in Liver Disease Research
By harnessing real-world data and advanced methodologies, Target RWE is transforming how researchers close evidence gaps, mitigate regulatory risk, and accelerate the development of liver disease therapies. The company's comprehensive approach to data collection and analysis provides a foundation for evidence-based practices that meet the needs of the liver disease community.
The TARGET-LD study encompasses multiple liver disease subpopulations, including metabolic dysfunction-associated steatotic liver disease (MASLD), hepatitis B virus (HBV), hepatocellular carcinoma (HCC), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), cirrhosis, Alpha-1 anti-trypsin deficiency, alcoholic liver disease (ALD), and Wilson's disease.
As liver disease care evolves, Target RWE remains positioned as a trusted partner in driving the future of data-informed clinical research, offering researchers, clinicians, and industry stakeholders critical insights to accelerate drug development and improve clinical practices.
