Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients

Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study

Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.

Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.

To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Adalimumab

Detailed Description

Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.

The cytokine tumor necrosis factor (TNF)-related weak inducer of apoptosis (TWEAK), in cooperation with its sole receptor, Fn14, is involved in miscellaneous biological and pathological processes .

The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines. The upregulation of TWEAK and Fn14 occurs in many human skin disorders, including cutaneous lupus erythematosus, bullous pemphigoid, and dermatomyositis . There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis.

The introduction of anti-tumor necrosis factor-α inhibitors (anti-TNF agents) has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents.

Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks, according to recent findings.

Methotrexate (MTX)was approved for the treatment of psoriasis by the US Food and Drug Administration (FDA). At present, the drug is indicated for the treatment of practically all forms of moderate or severe psoriasis, including psoriatic arthritis .

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eisa Mohamed Hegazy, Professor; Phone Number: +201094337795; Email: eisa_mohamed4152@med.svu.edu.eg

Study Locations

• Egypt
  • Qinā, Egypt
    • South Valley Hospitals
    • Contact: Eisa Mohamed Hegazy, Professor; Phone Number: +201094337795; Email: eisa_mohamed4152@med.svu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• TWEAK serum level assessment: blood sample (about 5cc) from the antecubital vessel of well-being control candidates and psoriatic candidates before and after MTX and Adalimumab therapy.
• Lipid profile will be calculated for patients treated, Liver & renal function will be measured and HCV, HBV and TB .

Description

Inclusion Criteria:

• Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
• Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs

Exclusion Criteria:

• Previously received biologic immunomodulating agents, except for those targeting TNF
• Previously been treated with three or more different TNF inhibitors
• Active, ongoing inflammatory diseases other than PsA
• Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
• A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
• History of ongoing, chronic or recurrent infections, or evidence of active TB infection
• History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)
• Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation
• Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A : (Adalimumab therapy); About 30 patients suffering from Plaque Psoriasis and will take Adalimumab therapy orally. Correlation between serum& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post Adalimumab therapy	Drug: Adalimumab; To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.; Other Names: Methotrexate
Group B : (methotrexate therapy); About 30 patients suffering from Psoriatic arthritis and will take methotrexate therapy orally. Correlation between serum& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post methotrexate therapy	Drug: Adalimumab; To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.; Other Names: Methotrexate
Group C: (control Group): About 40 healthy individuals selected as control group as related to age, sex ,BMI matching with healthy individuals	Drug: Adalimumab; To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.; Other Names: Methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of psoriasis vulgaris and psoriatic arthritis	to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of serum TWEAK	To detect the correlation between serum TWEAK the PASI score and the ACR score pre and post Methotrexate and Adalimumab therapy	1 year

Collaborators and Investigators

• Sponsor: Egymedicalpedia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Tumor Necrosis Factor Inhibitors; Adalimumab; Methotrexate
• Other Study ID Numbers: TWEAK in plaque psoriasis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No