Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments

Not yet recruiting

• Conditions: Psoriatic Arthritis (PsA); Liver Fibrosis; Liver Diseases

• Registration Number: NCT06918886
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-03-17
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-10
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score	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.

Secondary Outcome Measures

Name	Time	Method
Identification of High-Risk Patients	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.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey