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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52624

Enrollment

142

Registered

2020-02-27

Start date

2020-08-20

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Primary outcome is the cumulative incidence of persistent flares (PASI> 5 for >= 3 months).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results