Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-07-20

Brief Summary

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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

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Detailed Description

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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

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled non-inferiority study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose decrease

Patients receive daily practice care, but doses of etanercept, adalimumab or ustekinumab will be lowered: intervals of drug-administration will be prolonged stepwise with tight control of disease activity and DLQI. First, the dose will be decreased to 66-70% of the normal dose (by interval prolongation with a factor 1.5). If patients remain in a state of low disease activity, the dose will be further reduced to 50% (by doubling the original interval). Each step will be analyzed after three months, or when the patient visits earlier due to complaints.

Group Type EXPERIMENTAL

Dose decrease

Intervention Type OTHER

Treatment strategy change: dose decrease based on PASI and DLQI

Usual care

Patients will continue treatment with the normal dose and treatment regimens will be based on usual daily practice care. Treatment decisions are made at the discretion of the treating physician.

Group Type OTHER

Usual care

Intervention Type OTHER

Usual care

Interventions

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Dose decrease

Treatment strategy change: dose decrease based on PASI and DLQI

Intervention Type OTHER

Usual care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sustained low disease activity as described above on the dose as advised by the label.
* Established diagnosis of plaque psoriasis.
* Receiving treatment with adalimumab, etanercept, or ustekinumab for at least 6 months.\*
* Age ≥18 years.
* Ability to understand informed consent, read and answer questionnaires.

Exclusion Criteria

* Psoriasis itself is not the main reason for biologic prescription (e.g. when a patient has RA and psoriasis, and RA is the main reason for the biologic).
* Concomitant use of immunosuppressants other than methotrexate or acitretin for psoriasis.
* Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
* Presumed inability to follow the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No