Effectiveness of Biologics on Synovitis and Enthesitis Using Musculoskeletal Ultrasound Assessment in Subclinical Psoriatic Arthritis: a 12-week Observational Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement of synovitis and enthesitis after 12 weeks of treatment with biological agents.
研究概览
简要总结
Psoriatic arthritis (PsA) is one of the most common comorbidities in patients with psoriasis (PsO). Current research suggests that the progression from PsO to PsA can be divided into five stages of the disease: PsO, preclinical PsA, subclinical PsA, prodromal PsA, and clinical PsA. Subclinical PsA refers to psoriasis participants who do not exhibit any clinical symptoms of arthritis but show evidence of synovio-enthesitis on ultrasound (US). However, there is currently no definitive biomarker that can accurately predict the progression from PsO to PsA. Synovitis and enthesitis are considered important features of PsA. Musculoskeletal ultrasound, using B-mode ultrasound and power Doppler (PD), can visualize synovitis and enthesitis, allowing for the early detection of subclinical PsA, as confirmed by multiple studies. Biologics are currently widely used in the treatment of PsA, with current treatment interventions primarily focusing on patients already diagnosed with PsA. In this study, we conducted a rigorous screening process to identify potential subclinical PsA patients among those with moderate to severe psoriasis. We treated these subclinical PsA patients with biologics and used musculoskeletal ultrasound as a method of efficacy assessment to observe the improvement of synovitis and enthesitis in subclinical PsA patients after 12 weeks of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •diagnosed with moderate to severe plaque psoriasis
- •no inflammatory arthritis manifestations
- •Psoriasis Epidemic Severity Tool (PEST) score ≤ 2
- •negative rheumatoid factor
- •no prior use of any biologic treatments for psoriasis
- •abnormal findings on musculoskeletal ultrasound screening
排除标准
- •a previous diagnosis of any other type of arthritis, including rheumatoid arthritis, osteoarthritis, gouty arthritis, ankylosing spondylitis, or similar conditions
- •patients with contraindications to the use of biologics
- •pregnant or breastfeeding women, and women of childbearing potential who do not agree to use contraception.
研究组 & 干预措施
Subclinical psoriatic arthritis patients
干预措施: Biologics (Drug)
结局指标
主要结局
Improvement of synovitis and enthesitis after 12 weeks of treatment with biological agents.
时间窗: From enrollment to the end of treatment at 12 weeks
The assessment using ultrasound was performed at two time points: baseline (0 weeks) and 12 weeks after medication initiation. The joint examination sites were based on the PsAson22. The examination sites for enthesitis were based on the Leeds Enthesitis Index (LEI). According to the European League Against Rheumatism (EULAR)- the Outcome Measures in Rheumatology (OMERACT) definition, the 22 joints with synovitis were scored using ultrasound composite semi-quantitative scale. Additionally, the 6 sites of entheses were evaluated according to the OMERACT enthesitis composite semi-quantitative scale. When assessing joint synovitis and enthesitis using grey scale (GS) and power Doppler (PD), we take the higher score as the final score for that site (range 0 to 3). The total score is the sum of the scores for each site, ranging from 0 to 84. Assess the improvement of Sub-PsA patients by evaluating changes before and after treatment through the scoring of synovitis and enthesitis.
次要结局
未报告次要终点
研究者
Chao Ji
professor
First Affiliated Hospital of Fujian Medical University