Psoriatic Arthritis (PsA)FIB-4 PsANCT06918886
Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments
An observational study of Psoriatic Arthritis (PsA) and Liver Fibrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis (PsA), Liver Fibrosis, Liver Diseases
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
Mehmet Serkan Kılıçoğlu, MD, +905309734511, dr.serkan.kilicoglu@gmail.com
Safa El Mardi Alaoui, MD, +905350770520, elmardi.safa@gmail.com
About this study
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
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.
Read the 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.
- 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
- Medical subject headings
- Arthritis, Psoriatic, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome assessment at 24 months post-treatment initiation
Secondary outcomes (1)
Identification of High-Risk Patients
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.
Measured: Outcome assessment at 24 months post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic Arthritis (PsA)Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Serkan Kılıçoğlu, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918886
- Sponsor's protocol ID
- 2024/400
- Acronym
- FIB-4 PsA
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32446022Verhoeven 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.
PubMed 39084400
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06918886
- Acronym / sponsor ID
- FIB-4 PsA / 2024/400
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Identification of High-Risk Patients
Time frame: Outcome assessment at 24 months post-treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 32446022Verhoeven 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.
- Background: PubMed 39084400Verhoeven 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehmet Serkan Kılıçoğlu, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis (PsA) and Liver Fibrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Serkan Kılıçoğlu, MD (+905309734511, dr.serkan.kilicoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score (time frame: Outcome assessment at 24 months post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.