A Real-World Study of Biologic Therapy for Subclinical Psoriatic Arthritis

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.

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Key information

Conditions

Subclinical Psoriatic Arthritis Joint Diseases Musculoskeletal Diseases Synovitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 35000000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Biologics

Drug

The ultrasonic changes of synovitis and enthesitis were observed after 12 weeks of treatment with biologic agents

Primary outcomes

Improvement of synovitis and enthesitis after 12 weeks of treatment with biological agents.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chao Ji

Other

Registry information

Official study title

Effectiveness of Biologics on Synovitis and Enthesitis Using Musculoskeletal Ultrasound Assessment in Subclinical Psoriatic Arthritis: a 12-week Observational Real-world Study

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Nov 13, 2024
Registry last updated: Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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