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Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

a study on Psoriasis Arthritis Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
study ends around
Principal Investigator
by Monica Guma (ucsd)
Headshot of Monica Guma
Monica Guma

Description

Summary

The goal of this research study is to better understand if there is an association between non-alcoholic fatty liver disease (NAFLD) and active psoriatic disease (PD), and to assess the effect of Guselkumab (a medication approved by the FDA instead of the standard of care to treat PD), for NAFLD patients who receive Guselkumab for their PD.

Official Title

Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Disease (PD) Severity With Guselkumab Therapy [EMERGE]

Details

This observational research study aims to provide information on the mechanisms behind the transition from NAFLD to high-risk NASH in the PD population. Overlapping mechanisms of disease in NAFLD and PD may account for increased disease prevalence and severity, and shared drivers of disease progression offer the opportunity to ameliorate both disease entities by targeting a single pathway. This is a longitudinal study that requires two visits from individuals with psoriatic disease. Subjects must have NAFLD and at least one criterion for active psoriatic disease: i) at least 1 swollen joint or 1 site of active enthesitis; and/or (ii at least 1 psoriatic plaque to qualify for the study. The aim of the study is to determine the effect of biological therapies in liver disorders in patients with PD, in addition to the effect on joint and skin manifestations.

Keywords

Psoriasis (PsO), PsA (Psoriatic Arthritis), NAFLD (Nonalcoholic Fatty Liver Disease), psoriasis, psoriatic arthritis, guselkumab, NAFLD, non-alcoholic fatty liver disease, Guselkumab Prefilled Syringe [Tremfya]

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adults with a diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
  • Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
  • Patients are starting Guselkumab therapy as indicated by primary rheumatologist
  • Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease8.

You CAN'T join if...

  • Evidence of other causes of chronic liver disease
  • Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
  • Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
  • Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
  • Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
  • Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
  • Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
  • Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
  • Drug-induced liver disease as defined on the basis of typical exposure and history.
  • Bile duct obstruction as shown by imaging studies.
  • History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone, or tetracycline in the previous 6 months.
  • Evidence of cirrhosis or previously known cirrhosis based on the results from a previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy, or varices
  • Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any time in the last 10 years
  • The subject is a pregnant or nursing female
  • History of known HIV infection

Lead Scientist at University of California Health

  • Monica Guma (ucsd)
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 90 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07255781
Study Type
Observational
Participants
Expecting 20 study participants
Last Updated