Proactive TDM Versus Standard Use of Biologics in Psoriasis

Launched by UNIVERSITY HOSPITAL, GHENT · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to improve the treatment of psoriasis, specifically a common type known as psoriasis vulgaris. It compares two approaches to dosing biologic medications, which are special drugs used to manage this skin condition. One group of participants will have their dosages adjusted based on the actual amount of the drug found in their blood, while the other group will continue with the standard fixed doses. The goal is to find the right amount of medication for each patient to ensure they get the best results with fewer side effects and lower treatment costs.

To be eligible for the study, participants must be adults aged 18 or older who have been diagnosed with psoriasis and have been on specific biologic treatments (secukinumab, ixekizumab, or guselkumab) for at least six months. Participants will be monitored to see how well the treatments are working and how they feel about their quality of life. This trial is taking place in 14 hospitals across Belgium, and it aims to provide valuable insights that could lead to more personalized and effective psoriasis treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults; aged 18 years or older
• • 2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
• • 3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.
• • 4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures
• Exclusion Criteria:
• • 1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)
• • 2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)
• • 3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline
• • 4. Presumed inability to follow the study protocol
• • 5. Active pregnancy wish