Use of Serum M2BP and MSUS to Predict Arthritis in Psoriatic Patients

Study Overview
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Brief Summary
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Aims of the study: Measurement of serum level of Mac 2 binding protein among patients with psoriasis, psoriatic arthritis and subclinical psoriatic arthritis compared with healthy individuals. Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.

Detailed Description
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Psoriasis is a quite common chronic, inflammatory immune-mediated skin disease affecting about 2% of the population . Also psoriasis is a strong risk factor for the development of several comorbidities of which the most common is psoriatic arthritis (PsA). The presence of cutaneous psoriasis indicates a high risk for developing PsA. Studies conducted in dermatology clinics have shown a high prevalence of undiagnosed PsA in psoriasis patients , therefore identifying soluble biomarkers for PsA in psoriasis patients may help in early diagnosis, and thereby prevent disability and improve quality of life . Mac 2 binding protein [M2BP] is thought to be a marker of synovial cell activation and joint destruction .M2BP may be involved in the pathogenesis of PsA . Recently, with the introduction of new medications and wider use of musculoskeletal ultrasound (US) imaging in clinical practice, the possibility of earlier US diagnosis in patients with psoriasis in the pre-clinical phase of PsA has been examined.

Official Title
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Use of Serum Mac-2 Binding Protein and Musculoskeletal Ultrasound to Predict Arthritis in Psoriatic Patients

Conditions
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Psoriasis

Intervention / Treatment
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* Diagnostic Test: serum level of Mac 2 binding protein
* Device: musculoskeletal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis Exclusion Criteria: any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA malignancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>45 patients with cutaneous psoriasis with no musculoskeletal manifestations. | Diagnostic Test: serum level of Mac 2 binding protein<br>* Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA). 2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment.<br>Device: musculoskeletal ultrasound<br>* MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.<br>|
| Group 2<br>45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA | Diagnostic Test: serum level of Mac 2 binding protein<br>* Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA). 2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment.<br>Device: musculoskeletal ultrasound<br>* MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.<br>|
| Group 3<br>45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA). | Diagnostic Test: serum level of Mac 2 binding protein<br>* Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA). 2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment.<br>Device: musculoskeletal ultrasound<br>* MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.<br>|
| Group 4<br>45 sex and age matched healthy controls | Diagnostic Test: serum level of Mac 2 binding protein<br>* Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA). 2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment.<br>Device: musculoskeletal ultrasound<br>* MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of serum level of M2BP among psoriasis , psoriatic arthritis and subclinical psoriatic arthritis patients compared with healthy individuals and evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis | detection of the role of serum level of Mac 2 binding protein and MSUS to predict arthritis among psoriatic patients | baseline |