Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

Study Overview
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Brief Summary
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This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.

Official Title
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Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe plaque psoriasis Loss of satisfactory response to adalimumab Currently receiving or recently discontinued treatment with adalimumab Exclusion Criteria: Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis Serious medical conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept 50 mg<br>Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks. | Drug: Etanercept<br>* Administered by subcutaneous injection<br>* Other names: Enbrel®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). | Week 12 | 
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). | Weeks 4, 8, 16, 20 and 24 | 
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). | Weeks 4, 8, 16, 20 and 24 | 
| Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported. | Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported. | Weeks 4, 8, 12, 16, 20 and 24 | 
| Static Physician Global Assessment (sPGA) at Each Visit | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). | Weeks 4, 8, 12, 16, 20 and 24 | 
| Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). | Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 50 Response at Each Visit | A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 75 Response at Each Visit | A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 90 Response at Each Visit | A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 
| Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 
| Patient Satisfaction With Treatment at Week 12 | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied. | Week 12 | 
| Patient Satisfaction With Treatment at Week 24 | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied. | Week 24 | 
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. 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 answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement. | Baseline and Weeks 12 and 24 | 
| Change From Baseline in Work Productivity and Activity Impairment (WPAI) | The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement. | Baseline and Weeks 12 and 24 | 
| Change From Baseline in Patient Assessment of Itch | The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating no itch at all and 10 indicating worst itch imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement. | Baseline and Week 12 and 24 | 
| Change From Baseline in Patient Assessment of Pain | The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating does not hurt at all and 10 indicating worst hurt imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement. | Baseline and Week 12 and 24 | 
| Change From Baseline in Patient Assessment of Flaking | The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating no flaking at all and 10 indicating worst flaking imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement. | Baseline and Week 12 and 24 | 
| Number of Participants With Adverse Events | A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product. | From first dose of study drug until 30 days after the last dose (up to 28 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque psoriasis, etanercept, adalimumab