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Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients with disease remission using normal dose of biologics.
Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2) normal dose.
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
Full description
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. These drugs have significantly improved the quality of life of psoriasis patients, but are very expensive drugs that should be used as efficiently as possible. In addition, the long-term safety profile can probably be improved if patients receive the lowest effective dose.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: Is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence dose tapering has on quality of life, whether there are predictors for successful dose reduction, and to determine the cost-effectiveness of dose reduction.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients who used a biologic for at least 6 months (etanercept, adalimumab, ustekinumab) can be included if they have long-term stable low disease activity. Low disease activity is defined as a PASI score (Psoriasis Area and Activity Score) <5 and a health-related quality of life score ≤5 (Dermatology Quality of life index: DLQI).
Intervention: 120 patients will be randomized into two groups: (1) dose reduction guided by PASI and DLQI (n=60, intervention) and (2) maintenance of normal dosage (n=60, usual care).
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
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120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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