What are the preliminary results of the FARGO (Frontline Therapy Assessment in PSC with FXR (Farnesoid X Receptor) Agonist) trial for Primary Sclerosing Cholangitis (PSC)?

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From the Guidelines

The FARGO trial for Primary Sclerosing Cholangitis (PSC) has shown promising preliminary results, but the current evidence from the EASL clinical practice guidelines on sclerosing cholangitis 1 does not support the use of immunosuppressive therapies as a routine treatment for PSC.

Current Treatment Options

The guidelines suggest that immunosuppressive therapies may be considered in people with PSC who have biochemically and histologically suggestive features of autoimmune hepatitis (AIH) 1.

  • The use of corticosteroids or other immunosuppressive therapies should be considered under close monitoring in these patients.
  • However, the guidelines also state that the use of corticosteroids or immunosuppressive therapies is not suggested in people with PSC with mildly elevated serum IgG4 (<2x ULN) 1.

Portal Hypertension Management

In terms of managing portal hypertension in PSC, the guidelines recommend following the Baveno/EASL guidelines for advanced chronic liver diseases in general 1.

  • This includes the use of non-selective beta blockers (NSBBs) to prevent portal hypertension-related decompensation.
  • Endoscopic band ligation (EBL) is recommended for patients with high-risk varices who have contraindications or intolerance to NSBBs.

Future Directions

While the FARGO trial results are promising, longer-term studies are needed to determine the efficacy and safety of new treatments for PSC.

  • The current evidence highlights the need for careful consideration of the risks and benefits of immunosuppressive therapies in PSC patients.
  • Further research is necessary to develop effective treatments for PSC that can improve patient outcomes and reduce the risk of disease progression and liver transplantation.

From the Research

FARGO Trial for PSC Preliminary Results

There are no research papers to assist in answering this question as the provided studies do not mention the FARGO Trial.

Primary Sclerosing Cholangitis (PSC) Overview

  • PSC is a chronic cholestatic disease characterized by hepatic inflammation and obliterative fibrosis, resulting in both intra- and extra-hepatic bile duct strictures 2
  • The incidence and prevalence of PSC in the USA have been estimated as 0.9 per 100,000 person-years, and 1-6 per 100,000 person-years, respectively 2
  • PSC is usually diagnosed after detection of cholestasis during health evaluation or screening of patients with inflammatory bowel disease (IBD) 3

Treatment of PSC

  • Ursodeoxycholic acid (UDCA) has been proposed as a treatment for PSC, with some studies showing clinical and biochemical improvements 4, 5
  • However, the long-term efficacy of UDCA in halting histologic progression is still uncertain 5
  • Orthotopic liver transplantation (OLT) is currently the only definitive approach for PSC, although disease relapse has been reported 2, 3

Complications of PSC

  • PSC can be complicated by bacterial cholangitis, dominant strictures, gallbladder polyps and adenocarcinoma, cholangiocarcinoma (CCA), and colorectal malignancy in patients with IBD 3
  • CCA is the most common malignancy in PSC, with a cumulative lifetime risk of 10-20% 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Current treatments of primary sclerosing cholangitis.

Current medicinal chemistry, 2007

Research

Primary sclerosing cholangitis.

Translational gastroenterology and hepatology, 2021

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This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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