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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score
时间窗: 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.
次要结局
- Identification of High-Risk Patients(Outcome assessment at 24 months post-treatment initiation)