Serum Level of IL-33 in Egyptian Psoriatic Patients (CYC-IL33-PSO)

Cyclosporine Mitigated the Augmented Serum Level of IL-33 in Egyptian Psoriatic Patients in Relation to Disease Severity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Egyptian Psoriatic Patients
• Intervention / Treatment: Diagnostic test: serum interleukin 33 measurement; Diagnostic test: PASI score

Detailed Description

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 (Estimated): 118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Randomized controlled trial study following ethical guidelines (Approval No.: AFMC-PSO-2023/011) at Dermatology outpatient clinic in Kobry El Kobba Hospital. A 118 Egyptian Patients with psoriasis were recruited in the study where 59 treated with methotrexate group, and 59 for treatment with, cyclosporine group.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Methotrexate group; measure methotrexate serum level.	Diagnostic test: serum interleukin 33 measurement; 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.; Other Names: IL-33 serum level; Diagnostic test: PASI score; 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
Cyclosporine group; measure cyclosporine serum level.	Diagnostic test: serum interleukin 33 measurement; 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.; Other Names: IL-33 serum level; Diagnostic test: PASI score; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	maesure the serum level of IL-33 before and after 3 months from taking Methotrexate and Cyclosporine

Collaborators and Investigators

• Sponsor: scientific_committee

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: pharmacology1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No