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

NCT06918886 | Not Yet Recruiting

• 1 other identifier: 2024/400
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score

  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 Outcomes (1)

• Identification of High-Risk Patients

  Outcome assessment at 24 months post-treatment initiation

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32446022 BACKGROUND

• 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.

  PMID: 39084400 BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic; Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Serkan Kılıçoğlu, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Serkan Kılıçoğlu, MD

CONTACT

+905309734511; dr.serkan.kilicoglu@gmail.com

Safa El Mardi Alaoui, MD

CONTACT

+905350770520; elmardi.safa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 9, 2025
• Study Start: April 10, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)