Psoriasis Clinical Trial
Official title:
Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity: A Randomized Pragmatic Trial
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
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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