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 probably, not every patient needs this. Therefore, in patients with low disease activity under a normal dose, we want to examine if the dose can be reduced. A lower dose has advantages: it may lead to fewer side effects and lower healthcare costs. It is however important that the disease does not worsen due to dose reduction. We will investigate the best way to reduce the dose, and which patients are eligible for dose reduction. In 17 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. 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.
| Summary of results |
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This study included 244 patients. After 18 months, it was found that most patients who used a lower dose were able to keep their psoriasis under control just as well as patients who continued the standard dose. Some participants experienced a return of symptoms. These patients were able to go back to their original dose, and their psoriasis was usually brought back under control quickly. No serious side effects related to lowering the dose were found. These results show that gradually reducing the dose can be a safe and effective option for many patients. The findings suggest that people whose psoriasis has been stable for a long time may need less medication than is currently prescribed as standard treatment. This could bring several benefits for patients, including lower exposure to medication, fewer injections, and continued good control of their psoriasis. For society, it could help reduce healthcare costs. This study is expected to make an important contribution to future discussions about evaluating or updating treatment guidelines in both Belgium and the Netherlands. |
| Title |
Dose reduction of the new generation biologics (interleukin 17 and interleukin 23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study |
|
Participants (P) |
Patients treated with the newest generation of biologics (IL17 or IL23 inhibitors), with long-term stable low disease activity at a normal dose. |
|
Intervention (I) |
Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low |
|
Control (C) |
Usual care |
|
Outcome (O) |
Cumulative incidence of persistent flares (PASI> 5 for ≥ 3 months) |
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Trial Design |
Open-label, multi-centric randomised study; patients are randomized (2:1) to dose reduction or continuation of usual care |
|
Sample Size |
244 patients |
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Trial duration |
41 months (FPI to CSR) |
|
Budget |
1 609 339,15 € (798 919,85 € in BE) |
| Sponsor | Sponsor NL: Radboudmc, Nijmegen Belgian Coordinating Centre: UZ Gent |
| Chief Investigator | NL: Prof Dr E de Jong BE: Prof Dr J Lambert |
| Trial coordinator/PM | Rani Soenen Universitair Ziekenhuis Gent |
| Sites | 8 sites in Belgium and 9 sites in the Netherlands |
| External Partners | KU Leuven (analysis of drug levels and antibodies) |
Clinicaltrials.gov: NCT04340076
Webpage: BeNeBio website
