Dose reduction of the new generation biologicals (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study

• Conditions: Psoriasis

• Registration Number: NL-OMON22341
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 244

Inclusion Criteria

•Plaque psoriasis (primarily)
•Treatment for at least 6 months with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
•PASI= 5 at inclusion and in previous 6 months (if no PASI scores are available, it should be clear from the patient record that psoriasis was clear/almost clear in previous 6 months).
•DLQI = 5 at inclusion

Exclusion Criteria

•Another indication than plaque psoriasis as the main indication for biologic use (e.g. patient receives biologic for rheumatoid arthritis as the main indication).
•Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc).
•Severe comorbidities with short life-expectancy (e.g. metastasized tumor).
•Presumed inability to follow the study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferiority of the incidence proportion of persistent flares (PASI > 5 for = 3 months) in the intervention group.