Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (REFINE)

Amgen

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Topical agents; Biological: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01313221

20090647

Details and patient eligibility

About

To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.

Full description

The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.

The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.

Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
• Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
• Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
• Other inclusion criteria may apply.

Exclusion criteria

• Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
• Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.
• Diagnosed with medication-induced or medication-exacerbated psoriasis.
• Significant concurrent medical conditions.
• Has any active localized infection; requiring local intervention or chronic or localized infections.
• Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Etanercept 50 mg BIW

Active Comparator group

Description:

Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.

Treatment:

Biological: etanercept

Etanercept 50 mg QW + Topical

Experimental group

Description:

Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.

Treatment:

Drug: Topical agents

Biological: etanercept