Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multi-centre, randomised, controlled, non-inferiority study - BeNeBio study (BeNeFIT18562)

Summary (French or English)

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.

Trial Description
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)

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

Trial duration

41 months (FPI to CSR)

Budget

1 609 339,15 € (798 919,85 € in BE)

Status

Open

 

Trial team

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

Lynda Grine

Universitair Ziekenhuis Gent

Dermatologie

Lynda.Grine@UZGENT.be

Sites

8 sites in Belgium and 9 sites in the Netherlands

External Partners

KU Leuven (analysis of drug levels and antibodies)

Documents
Protocol  
Report

Q2/2023

Publication

 

References

Clinicaltrials.gov: pending

Webpage: 

Funding scheme