Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity: A Randomized Pragmatic Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Radboud University Medical Center
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- Disease-activity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Detailed 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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Disease-activity
Time Frame: 1 year
Disease-activity measured by Psoriasis Area and Severity Index (PASI), effectiveness measure used in most psoriasis trials.
Secondary Outcomes
- Disease-activity measured with HsCRP(1 year)
- Costs related to medical consumption(1 year)
- Number of patients with 1 or more persistent flares(1 year)
- Health-related quality of life (HRQoL-DLQI)(1 year)
- Predictors for succesful dose decrease (treatment and patient characteristics)(1 year)
- Number of serious adverse events per patient(1 year)
- Drug trough levels of etanercept, adalimumab or ustekinumab(1 year)
- Costs related to productivity(1 year)
- Anti-drug antibody levels against etanercept, adalimumab or ustekinumab(1 year)
- Health status (SF36)(1 year)