Adjusting Biologic Dosing by Blood Drug Levels in Psoriasis
Tests whether blood drug level checks guide dosing of biologics in adults with psoriasis.
Plain-language title generated from the registry record
Registry title: Proactive TDM Versus Standard Use of Biologics in Psoriasis
Key facts
- Where
- Anderlecht, Brugge, Brussels, Eeklo, Geel, Gent, Gerpinnes, Jette, Kortrijk, Leuven, Liège, Maldegem, and Sint-Lambrechts-Woluwe, BelgiumSee the 14 sites
- Phase
- Phase 4
Where in Belgium
- Hopital ErasmeAnderlecht, BelgiumTaking people
- Az St-Jan Brugge-Oostende A.V.Brugge, BelgiumTaking people
- CHU Saint-PierreBrussels, BelgiumTaking people
- Algemeen Ziekenhuis AlmaEeklo, BelgiumTaking people
- Dermatologiepraktijk huidziekten GeelGeel, BelgiumTaking people
- Az Maria Middelares GentGent, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- Grand Hopital De CharleroiGerpinnes, BelgiumTaking people
- Universitair Ziekenhuis BrusselJette, BelgiumTaking people
- ASSOCIATIE DERMATOLOGIE Suys Erwin en Bonny Michiel FVKortrijk, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Centre Hospitalier Universitaire de LiègeLiège, BelgiumTaking people
- Associatie dermatologie MaldegemMaldegem, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Ghent
- Trial code
- NCT06398106EU 2023-509637-39-00
- Record updated
- 4 March 2026
- Original description
Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.Read full original descriptionShow less
Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.
Inclusion: Adults; aged 18 years or older; Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist; Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme; The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion: Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc); Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication); Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline; Presumed inability to follow the study protocol; Active pregnancy wish.