Clinical trial NCT06918886: Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psoriatic Arthritis (PsA)
Liver Fibrosis
Liver Diseases
Keywords: Psoriatic Arthritis
Liver Fibrosis
FIB-4 Score
Anti-TNF Therapy
Anti-IL17 Therapy
Biological Therapy
Liver Health
Retrospective Study
Hepatic Safety
Chronic Inflammatory Arthritis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score
timeFrame: Outcome assessment at 24 months post-treatment initiation
Secondary outcomes:
measure: Identification of High-Risk Patients
timeFrame: Outcome assessment at 24 months post-treatment initiation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Mehmet Serkan Kılıçoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhoeven F, Weil-Verhoeven D, Prati C, Martino VD, Thevenot T, Wendling D. Safety of TNF inhibitors in rheumatic disease in case of NAFLD and cirrhosis. Semin Arthritis Rheum. 2020 Aug;50(4):544-548. doi: 10.1016/j.semarthrit.2020.03.013. Epub 2020 May 11.
citation: Verhoeven F, Prati C, Di Martino V, Thevenot T, Demougeot C, Wendling D, Weil-Verhoeven D. Evolution of FIB-4 score in SpA and PsA patients taking anti-TNF or anti-IL17. Joint Bone Spine. 2024 Dec;91(6):105763. doi: 10.1016/j.jbspin.2024.105763. Epub 2024 Jul 29. No abstract available.