What is the BeNeBio study?
The BeNeBio study is a clinical study about dose reduction of biologics in patients with psoriasis who have low disease activity under a normal dose. The following biologics will be investigated: secukinumab (Cosentyx®), ixekizumab (Taltz®), brodalumab (Kyntheum®), bimekizumab (Bimzelx®), guselkumab (Tremfya®), risankizumab (Skyrizi®), tildrakizumab (Ilumetri®). Patients can participate if their psoriasis is stable and if they have a good quality of life during treatment with the normal dose for at least 6 months. The dose will be reduced in 2 steps until half of the normal dose.
With other biologics there is some evidence that a lower dose can be as effective as the standard, normal dose. Therefore, we want to investigate if the dose can be reduced as well with the newer biologics. We will investigate the best way to reduce the dose, and which patients are eligible for dose reduction. In case of worsening of the psoriasis, patients can go back to the normal dose.
In 19 Belgian and Dutch hospitals, we will divide patients into 2 study groups: a group that gradually reduces the dose and a group that continues to use the normal dose.
Patients are having a 67% chance to enter the dose reduction group.
We will investigate if the reduced dose does not lead to a worsening of psoriasis and if quality of life remains stable. We will also investigate side effects, costs and the blood levels of the medication. With this research we hope to achieve that a part of patients can reduce their dose safely, while the effect on the skin remains good.
Which data are collected?
Patients will have outpatient visits every 3 months during 1.5 year. In general, the collected data is data that is also usually recorded by physicians in daily practice, such as disease severity, dosages of medication, and side effects. In addition, questionnaires are sent to patients every 3 months to measure quality of life, general health, and cost effectiveness. Patients are asked to complete a medication and side effects diary. After every visit, an extra vial of blood will be drawed. With this we want to investigate the blood levels of the medication and if there are antibodies against the medication.
During every outpatient visit (every 3 months):
- Disease activity with PASI score (Psoriasis Area and Severity Index)
- Quality of life with DLQI questionnaire (Dermatology Life Quality Index)
- Side effects
- Changes in other medication
- Extra vial of blood
Every 3 months, 4 questionnaires will be sent:
- EQ-5D-5L (health status questionnaire)
- SF-36 (health survey)
- Cost effectiveness questionnaires (MCQ; Medical Consumption Questionnaire, PCQ; Productivity Cost Questionnaire)