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

Amgen310 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

310

Conditions

Psoriasis

Interventions

etanerceptBIOLOGICAL

Administered by subcutaneous injection

Topical agentsDRUG

Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following: * hydrocortisone 2.5% * betamethasone valerate 0.1% * betamethasone dipropionate 0.05% * clobetasol 0.05% * calcitriol * calcipotriol plus betamethsone dipropionate 0.05%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Research Site

Calgary, Alberta, Canada

Research Site

Outcomes

Primary Outcomes

Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Time frame: Week 12 and Week 24

Secondary Outcomes

Percent Change in PASI From Week 12 to Weeks 16 and 20

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value \* 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Time frame: Week 12, Week 16 and Week 20

Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value \* 100, so that a positive change indicates improvement.

Data from ClinicalTrials.gov

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Surrey, British Columbia, Canada

Research Site

Vancouver, British Columbia, Canada

Research Site

Winnipeg, Manitoba, Canada

Research Site

Moncton, New Brunswick, Canada

Research Site

St. John's, Newfoundland and Labrador, Canada

Research Site

St. John's, Newfoundland and Labrador, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Courtice, Ontario, Canada

Research Site

Greater Sudbury, Ontario, Canada

...and 14 more locations

Time frame: Baseline and Weeks 12, 16, 20, and 24

Percentage of Participants With a PASI 50 Response

The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Time frame: Baseline and Weeks 12, 16, 20 and 24

Percentage of Participants With a PASI 75 Response

The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Time frame: Baseline and Weeks 12, 16, 20 and 24

Percentage of Participants With a PASI 90 Response

The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Time frame: Baseline and Weeks 12, 16, 20 and 24

Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)

The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).

Time frame: Weeks 12, 16, 20, and 24

Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value \* 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Time frame: Weeks 12, 16, 20, and 24

Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Baseline \\ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value \* 100, so that a positive change indicates improvement.

Time frame: Baseline and Weeks 12, 16, 20, and 24

Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Time frame: Week 12 and Week 24

Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.

Time frame: Baseline and Week 12 and Week 24

Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24

TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.

Time frame: Week 12 and Week 24

Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24

The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.

Time frame: Baseline and Weeks 12 and 24

Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician's office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.