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

Phase 4

Recruiting

Conditions: psoriasis
10014982

Registration Number: NL-OMON52624

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 142

Inclusion Criteria

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

Exclusion Criteria

• Another indication than plaque psoriasis as the main indication for biologic
use (e.g. 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 tumour).
• Presumed inability to follow the study protocol.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the cumulative incidence of persistent flares (PASI> 5 for >=<br /><br>3 months). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the percentage of successful dose reductions, the course<br /><br>of disease activity (PASI), incidence of short disease flares (PASI> 5 once),<br /><br>course of disease-related quality of life (DLQI), predictors for successful<br /><br>dose reduction, side effects, antibody formation and trough levels of biologics<br /><br>(PK), health-status (SF-36), quality-adjusted life-years (EQ-5D-5L), volumes of<br /><br>care (iMTA Medical Consumption Questionnaire), loss of productivity and<br /><br>presenteeism (Productivity Cost Questionnaire).</p><br>