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

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Other: Usual care; Other: Dose decrease

Study type: Interventional

Funder types: Other

Identifiers

NCT02602925

CONDOR

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Dose decrease

Experimental group

Description:

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.

Treatment:

Other: Dose decrease

Usual care

Other group

Description:

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.

Treatment:

Other: Usual care