Serum Level of IL-33 in Egyptian Psoriatic Patients

N/ANot Yet RecruitingNCT07557095

scientific_committee118 enrolled

Overview

This study aimed to compare the serum concentration levels of IL-33 in psoriatic patients undergoing treatment with two commonly prescribed immunosuppressive drugs, methotrexate and cyclosporine. Blood samples will be collected, Serum IL-33 concentrations will be measured using enzyme-linked immunosorbent assay (ELISA) techniques. Clinical assessments, including Psoriasis Area and Severity Index (PASI) scores, will be also recorded to evaluate disease severity and treatment efficacy.

Psoriasis is a chronic immune-mediated disease with significant clinical and immunological heterogeneity. Although methotrexate and cyclosporine are widely used in moderate to severe psoriasis, their comparative effects on IL-33 - a key pro-inflammatory cytokine - have not been adequately evaluated. In this randomized controlled trial involving 118 Egyptian psoriatic patients, we directly compared the therapeutic efficacy of methotrexate versus cyclosporine and analyzed their impact on serum IL-33 levels in relation to Psoriasis Area and Severity Index (PASI). Our findings demonstrated that while both drugs significantly reduced PASI scores and IL-33 serum levels, cyclosporine showed superior efficacy and achieved a greater reduction in both clinical severity and IL-33. A strong positive correlation was observed between IL-33 levels and PASI scores, supporting IL-33 as a reliable biomarker of disease activity and therapeutic response. This is one of the few clinical studies in Egypt and the region evaluating IL-33 modulation in psoriasis therapy. Our results may guide clinicians in selecting optimal systemic treatment and highlight IL-33 as a potential therapeutic target.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Egyptian Psoriatic Patients

Interventions

serum interleukin 33 measurementDIAGNOSTIC_TEST

Blood samples will be collected from participants under aseptic conditions. Serum will be separated and stored appropriately. Serum Interleukin-33 (IL-33) levels will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate its association with psoriasis.

PASI scoreDIAGNOSTIC_TEST

The Psoriasis Area and Severity Index (PASI) is the most widely utilized quantitative tool in clinical dermatology and pharmacological research for grading the severity of chronic plaque psoriasis. It provides a composite score based on the clinical manifestation of the disease across distinct anatomical regions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient included who had age more than 18 years old from both sexes, and manifested with moderate to severe psoriasis (according to the body surface area BSA): moderate; BSA 5-10 and severe; BSA \> 10) Exclusion Criteria: * Patient excluded from the study, who was pregnant or lactating women, and patient who had associated comorbidity namely inflammatory, autoimmune diseases , systemic diseases (mainly hypertension, renal, and hepatic diseases). In addition presence of any dermatologic diseases other than psoriasis, and history of receiving other systemic drugs, phototherapy for psoriasis within the last 6 months, or hypersensitivity to methotrexate and/or cyclosporine. Lastly, patients with body dismorphic disorders were also excluded.

Outcomes

Primary Outcomes

differences of the serum IL-33 levels in psoriatic patients

compare between Methotrexate and Cyclosporine in psoriatic patients in the IL-33 serum levels after use the drug for 3 months

Time frame: maesure the serum level of IL-33 before and after 3 months from taking Methotrexate and Cyclosporine

Data from ClinicalTrials.gov

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