Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments (FIB-4 PsA)

April 7, 2025 updated by: Bezmialem Vakif University

Evaluation of Liver Fibrosis and Hepatic Steatosis Using FIB-4 Score and Ultrasonography in Psoriatic Arthritis Patients Treated With TNF or IL-17 Inhibitors: A Retrospective Controlled Study

Psoriatic arthritis (PsA) is an inflammatory joint disease that can also affect the liver. Some medications used to treat PsA, such as biological agents (TNF-alpha inhibitors and IL-17 inhibitors), may influence liver health over the long term. This retrospective study aims to evaluate the presence and progression of liver fibrosis (scarring) and hepatic steatosis (fatty liver) in PsA patients treated with TNF-alpha inhibitors or IL-17 inhibitors.

The study includes PsA patients who have used biological medications continuously for at least 2 years. Patients' liver health will be assessed using non-invasive tests such as liver ultrasonography and validated biochemical scoring systems (FIB-4, APRI). The findings will be compared with PsA patients treated only with methotrexate (MTX), a commonly used medication known to affect liver health.

This study will help understand whether biological therapies (TNF or IL-17 inhibitors) have a positive or negative impact on liver health compared to traditional treatments (MTX) in patients with psoriatic arthritis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a retrospective, single-center observational study, conducted in the Physical Medicine and Rehabilitation Clinic, designed to assess the impact of long-term biologic therapy on liver health in patients with psoriatic arthritis (PsA). Participants must have received either TNF-alpha inhibitors or IL-17 inhibitors for at least two consecutive years. A separate group of PsA patients who have only received methotrexate (MTX) for at least two years will serve as a comparison cohort.

Objectives:

To estimate the frequency of hepatic steatosis and fibrosis using liver ultrasonography and validated biochemical scoring indices (FIB-4, APRI) among patients on biologic therapy and MTX.

To compare changes in fibrotic markers between baseline and the two-year follow-up period.

To determine whether long-term biologic therapy poses additional risk or provides any protective effect regarding the progression of liver disease.

Study Population:

Adult PsA patients aged 18 to 65 years, meeting standard classification criteria.

Biologic therapy group: ongoing anti-TNF or anti-IL-17 treatment for ≥2 years.

Control group: MTX therapy ≥2 years without biologic agents.

Methods:

Patient records from the rheumatology department will be reviewed retrospectively.

Liver ultrasonography, performed at baseline (or earliest available pre-biologic record) and at the two-year mark, will evaluate hepatic steatosis, if available in patient files.

Blood tests (AST, ALT, platelet count, total bilirubin, albumin, CRP) will be retrieved from clinical databases to calculate non-invasive liver fibrosis indices (e.g., FIB-4, APRI). Additional data on metabolic risk factors (BMI, diabetes, hypertension, dyslipidemia measured by total cholesterol, LDL, HDL, and triglyceride levels) will be extracted. Additionally, clinical information on enthesitis, dactylitis, and disease activity (assessed by DAPSA and/or PASI scores when available) will be recorded from patient files.

Statistical analysis will include group comparisons, correlation analyses, and multiple regression to adjust for confounding factors.

Significance:

Findings from this study will enhance understanding of whether TNF-alpha or IL-17 inhibitors elevate or mitigate the risk of liver disease progression relative to MTX therapy in PsA patients, providing a foundation for more tailored treatment decisions and long-term patient monitoring.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mehmet Serkan Kılıçoğlu, MD
        • Sub-Investigator:
          • Safa El Mardi Alaoui, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study population comprises adult PsA patients (aged 18 to 65) under active follow-up at the Physical Medicine and Rehabilitation Clinic. Eligible participants have confirmed PsA diagnoses and must have been treated either with methotrexate (MTX) alone or with biologic agents (anti-TNF or anti-IL-17) for at least two years. Data from medical records-including liver ultrasound reports, laboratory results, and relevant clinical assessments-will be collected retrospectively. Patients with significant alcohol use or other known causes of chronic liver disease are excluded. The sample is expected to encompass a range of disease severities, allowing for meaningful comparison of liver health outcomes across different therapeutic regimens.

Description

Inclusion Criteria:

  • Age 18 to 65 years
  • Diagnosed with psoriatic arthritis (PsA) according to standard classification criteria
  • Receiving biologic therapy (anti-TNF or anti-IL-17) or MTX monotherapy for ≥2 years
  • Able to provide historical data (medical records) on liver ultrasound and laboratory parameters

Exclusion Criteria:

  • History of any other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis)
  • Significant alcohol consumption (>20 g/day women, >30 g/day men)
  • Concomitant use of other hepatotoxic drugs apart from MTX
  • Unwillingness or inability to comply with study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1: Anti-TNF treatment
Psoriatic arthritis patients with outcome assessment at 24 months following the initiation of Anti-TNF biological treatment.
Group 2: Anti-IL17 treatment
Psoriatic arthritis patients with outcome assessment at 24 months following the initiation of Anti-IL-17 biological treatment.
MTX Control Group
This cohort comprises psoriatic arthritis (PsA) patients with outcome assessment at 24 months following the initiation of methotrexate (MTX) monotherapy. They will serve as the control group to compare the effects on liver health with those treated using biologic agents. No other specific interventions beyond standard MTX therapy are administered to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score
Time Frame: Outcome assessment at 24 months post-treatment initiation

The Fibrosis-4 (FIB-4) Index is a tool used for the noninvasive assessment of liver fibrosis. Comparison of liver fibrosis scores (FIB-4) calculated from AST, ALT, platelet counts, and age between Anti-TNF and Anti-IL17 treated Psoriatic Arthritis patients. There is no fixed minimum or maximum value; however, the following threshold values are commonly used in clinical interpretation:

<1.3: Low likelihood of advanced fibrosis 1.3-2.67: Indeterminate/intermediate risk >2.67: High likelihood of advanced fibrosis. Higher FIB-4 scores indicate the presence of more advanced liver fibrosis.
Outcome assessment at 24 months post-treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of High-Risk Patients
Time Frame: Outcome assessment at 24 months post-treatment initiation
Determining the percentage of patients with elevated FIB-4 scores suggestive of liver fibrosis risk in each treatment group (Anti-TNF vs. Anti-IL17).Higher FIB-4 scores indicate the presence of more advanced liver fibrosis.
Outcome assessment at 24 months post-treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Mehmet Serkan Kılıçoğlu, MD, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to patient confidentiality concerns and the retrospective nature of the data collection, which may limit consent for data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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