Psoriasis
Conditions
Keywords
plaque psoriasis, etanercept, adalimumab
Brief summary
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
Interventions
DRUGEtanercept
Administered by subcutaneous injection
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 | 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). |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Static Physician Global Assessment (sPGA) at Each Visit | Weeks 4, 8, 12, 16, 20 and 24 | 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). |
| Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Weeks 4, 8, 12, 16, 20 and 24 | 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). |
| Percentage of Participants With a PASI 50 Response at Each Visit | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With a PASI 75 Response at Each Visit | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With a PASI 90 Response at Each Visit | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Weeks 4, 8, 16, 20 and 24 | 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). |
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Baseline and Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Patient Satisfaction With Treatment at Week 12 | Week 12 | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied. |
| Patient Satisfaction With Treatment at Week 24 | Week 24 | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Baseline and Weeks 12 and 24 | 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. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Baseline and Weeks 12 and 24 | 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. |
| Change From Baseline in Patient Assessment of Itch | Baseline and Week 12 and 24 | 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. |
| Change From Baseline in Patient Assessment of Pain | Baseline and Week 12 and 24 | 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. |
| Change From Baseline in Patient Assessment of Flaking | Baseline and Week 12 and 24 | 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. |
| Number of Participants With Adverse Events | From first dose of study drug until 30 days after the last dose (up to 28 weeks) | A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product. |
| Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Baseline and weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Weeks 4, 8, 16, 20 and 24 | 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). |
Countries
Canada, United States
Participant flow
Recruitment details
This study was conducted at 48 centers in the United States (US) and Canada. Participants were enrolled from 01 February 2012 until 04 November 2014.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept 50 mg 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. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Requirement for Alternative Therapy | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Etanercept 50 mg |
|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 12.4 |
| Anti-adalimumab Antibody Status at Screening Negative | 21 participants |
| Anti-adalimumab Antibody Status at Screening Positive | 43 participants |
| Dermatology Life Quality Index (DLQI) | 12.7 units on a scale STANDARD_DEVIATION 6.7 |
| Patient Assessment of Flaking | 7.0 units on a scale STANDARD_DEVIATION 2.3 |
| Patient Assessment of Itch | 6.5 units on a scale STANDARD_DEVIATION 2.5 |
| Patient Assessment of Pain | 5.0 units on a scale STANDARD_DEVIATION 3.1 |
| Patient Assessment of Treatment Satisfaction Dissatisfied | 14 participants |
| Patient Assessment of Treatment Satisfaction Missing | 2 participants |
| Patient Assessment of Treatment Satisfaction Neither satisfied nor dissatisfied | 20 participants |
| Patient Assessment of Treatment Satisfaction Satisfied | 2 participants |
| Patient Assessment of Treatment Satisfaction Very dissatisfied | 24 participants |
| Patient Assessment of Treatment Satisfaction Very satisfied | 2 participants |
| Percent of Body Surface Area (BSA) Involved in Psoriasis | 20.90 percentage of BSA STANDARD_DEVIATION 16 |
| Psoriasis Area Severity Index (PASI) | 16.81 units on a scale STANDARD_DEVIATION 6.86 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 7 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 7 participants |
| Race/Ethnicity, Customized Multiple | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 57 participants |
| Race/Ethnicity, Customized White | 53 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 40 Participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 0 = Clear | 0 participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 1 = Almost clear | 0 participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 2 = Mild | 0 participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 3 = Moderate | 50 participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 4 = Severe | 14 participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 5 = Very severe | 0 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 64 |
| serious Total, serious adverse events | 2 / 64 |
Outcome results
Primary
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).
Time frame: Week 12
Population: The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 | 39.7 percentage of participants |
Primary
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).
Time frame: Week 12
Population: The primary analysis set with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status | 45.0 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status | 35.0 percentage of participants |
p-value: 0.450595% CI: [-15.97, 35.97]Wald asymptotic test
Secondary
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.
Time frame: Baseline and Weeks 12 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Week 12 (n = 60) | 7.9 units on a scale | Standard Deviation 7.9 |
| Etanercept 50 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Week 24 (n = 61) | 7.0 units on a scale | Standard Deviation 7.3 |
Secondary
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.
Time frame: Baseline and Week 12 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Flaking | Week 12 (n = 60) | 4.2 units on a scale | Standard Deviation 3.2 |
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Flaking | Week 24 (n = 61) | 3.6 units on a scale | Standard Deviation 3.6 |
Secondary
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.
Time frame: Baseline and Week 12 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Itch | Week 12 (n = 60) | 3.9 units on a scale | Standard Deviation 2.8 |
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Itch | Week 24 (n = 61) | 3.5 units on a scale | Standard Deviation 3.4 |
Secondary
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.
Time frame: Baseline and Week 12 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Pain | Week 12 (n = 60) | 3.4 units on a scale | Standard Deviation 3.1 |
| Etanercept 50 mg | Change From Baseline in Patient Assessment of Pain | Week 24 (n = 61) | 3.0 units on a scale | Standard Deviation 3.4 |
Secondary
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.
Time frame: Baseline and Weeks 12 and 24
Population: Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 12: Absenteeism (n = 43) | 1.35 units on a scale | Standard Deviation 5.03 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 24: Absenteeism (n = 43) | -1.62 units on a scale | Standard Deviation 15.87 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 12: Presenteeism (n = 38) | 14.47 units on a scale | Standard Deviation 24.24 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 24: Presenteeism (n = 41) | 11.22 units on a scale | Standard Deviation 19.65 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 12: Work Productivity Loss (n = 43) | 13.13 units on a scale | Standard Deviation 25.12 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 24: Work Productivity Loss (n = 43) | 8.93 units on a scale | Standard Deviation 21.68 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 12: Activity Impairment (n = 60) | 24.17 units on a scale | Standard Deviation 29.24 |
| Etanercept 50 mg | Change From Baseline in Work Productivity and Activity Impairment (WPAI) | Week 24: Activity Impairment (n = 61) | 17.87 units on a scale | Standard Deviation 26.59 |
Secondary
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.
Time frame: From first dose of study drug until 30 days after the last dose (up to 28 weeks)
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Number of Participants With Adverse Events | Any adverse event (AE) | 40 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | Serious adverse events | 2 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | AE leading to discontinuation of study drug | 1 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | AE leading to discontinuation from study | 1 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | Fatal adverse events | 0 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | Treatment-related adverse events (TRAE) | 16 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | Serious treatment-related adverse events | 1 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | TRAE leading to discontinuation of study drug | 1 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | TRAE leading to discontinuation from study | 1 participants |
| Etanercept 50 mg | Number of Participants With Adverse Events | Fatal treatment-related adverse events | 0 participants |
Secondary
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.
Time frame: Week 12
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 12 | Very dissatisfied | 3.3 percentage of participants | 95% Confidence Interval 0.4 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 12 | Dissatisfied | 13.1 percentage of participants | 95% Confidence Interval 0.8 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 12 | Neither satisfied nor dissatisfied | 21.3 percentage of participants | 95% Confidence Interval 0.9 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 12 | Satisfied | 29.5 percentage of participants | — |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 12 | Very satisfied | 32.8 percentage of participants | — |
Secondary
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.
Time frame: Week 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 24 | Dissatisfied | 21.0 percentage of participants | 95% Confidence Interval 0.8 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 24 | Satisfied | 29.0 percentage of participants | — |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 24 | Very dissatisfied | 9.7 percentage of participants | 95% Confidence Interval 0.4 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 24 | Neither satisfied nor dissatisfied | 16.1 percentage of participants | 95% Confidence Interval 0.9 |
| Etanercept 50 mg | Patient Satisfaction With Treatment at Week 24 | Very satisfied | 24.2 percentage of participants | — |
Secondary
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.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 4 | 52.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 8 | 71.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 12 | 84.1 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 16 | 76.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 20 | 76.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 24 | 73.0 percentage of participants |
Secondary
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.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 45.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 61.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 85.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 81.1 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 81.6 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 78.4 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 78.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 66.7 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 73.7 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 90.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 77.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 95.0 percentage of participants |
Secondary
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).
Time frame: Weeks 4, 8, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Week 4 | 4.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Week 8 | 23.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Week 16 | 39.7 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Week 20 | 42.9 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits | Week 24 | 38.1 percentage of participants |
Secondary
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).
Time frame: Weeks 4, 8, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 17.9 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 44.7 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 37.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 40.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 4.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 38.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 4.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 38.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 42.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 47.4 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 4 | 30.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 8 | 61.9 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 12 | 77.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 16 | 79.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 20 | 81.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response at Each Visit | Week 24 | 81.0 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 21.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 59.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 72.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 78.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 84.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 86.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 89.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 47.6 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 89.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 76.2 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 88.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 100.0 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 4 | 4.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 8 | 25.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 12 | 46.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 16 | 49.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 20 | 50.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response at Each Visit | Week 24 | 47.6 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 2.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 20.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 47.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 51.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 55.3 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 56.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 52.6 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 9.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 47.4 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 38.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 38.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 50.0 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 4 | 0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 8 | 3.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 12 | 22.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 16 | 25.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 20 | 19.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response at Each Visit | Week 24 | 23.8 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 5.1 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 27.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 27.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 23.7 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 32.4 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 15.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 0 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 21.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 0 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 11.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 15.0 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 4 | 65.1 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 8 | 79.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 12 | 85.7 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 16 | 79.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 20 | 77.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 24 | 76.2 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 64.3 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 74.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 87.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 86.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 84.2 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 83.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 78.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 66.7 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 73.7 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 90.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 77.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 95.0 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 4 | 9.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 8 | 31.7 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 12 | 54.0 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 16 | 52.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 20 | 52.4 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 24 | 49.2 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 11.9 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 30.8 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 67.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 59.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 60.5 percentage of participants |
| Etanercept 50 mg | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 59.5 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 47.4 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 4.8 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 42.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 38.1 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 38.9 percentage of participants |
| Anti-adalimumab Antibody Negative | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 35.0 percentage of participants |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 33.38 percent change | Standard Deviation 3.32 |
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 55.90 percent change | Standard Deviation 3.93 |
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 69.99 percent change | Standard Deviation 3.49 |
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 70.76 percent change | Standard Deviation 3.6 |
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 73.47 percent change | Standard Deviation 3.75 |
| Etanercept 50 mg | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 73.34 percent change | Standard Deviation 3.57 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 72.79 percent change | Standard Deviation 5.22 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 42.29 percent change | Standard Deviation 4.98 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 67.31 percent change | Standard Deviation 8.78 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 59.33 percent change | Standard Deviation 5.33 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 65.71 percent change | Standard Deviation 9.03 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 73.71 percent change | Standard Deviation 3.12 |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 4 | 36.02 percent change | Standard Deviation 22.09 |
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 8 | 55.33 percent change | Standard Deviation 25.25 |
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 12 | 67.97 percent change | Standard Deviation 24.2 |
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 16 | 67.98 percent change | Standard Deviation 29.83 |
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 20 | 69.58 percent change | Standard Deviation 26.16 |
| Etanercept 50 mg | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 24 | 67.25 percent change | Standard Deviation 30.41 |
Secondary
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 4 | 19.38 percent change | Standard Deviation 29.43 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 8 | 37.86 percent change | Standard Deviation 32.5 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 12 | 53.82 percent change | Standard Deviation 32.66 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 16 | 60.36 percent change | Standard Deviation 29.48 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 20 | 60.33 percent change | Standard Deviation 29.79 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis | Week 24 | 58.13 percent change | Standard Deviation 34.4 |
Secondary
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 24.41 percent change | Standard Deviation 3.99 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 40.34 percent change | Standard Deviation 5.32 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 58.58 percent change | Standard Deviation 4.72 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 61.21 percent change | Standard Deviation 4.83 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 65.56 percent change | Standard Deviation 4.75 |
| Etanercept 50 mg | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 65.30 percent change | Standard Deviation 5.68 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 20 (n = 38, 19) | 60.11 percent change | Standard Deviation 5.68 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 4 (n = 42, 21) | 15.32 percent change | Standard Deviation 7.83 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 16 (n = 37, 19) | 63.14 percent change | Standard Deviation 5.19 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 8 (n = 39, 21) | 34.36 percent change | Standard Deviation 7.23 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 24 (n = 37, 18) | 52.72 percent change | Standard Deviation 6.99 |
| Anti-adalimumab Antibody Negative | Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status | Week 12 (n = 40, 20) | 50.91 percent change | Standard Deviation 8 |
Secondary
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).
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 4 | 2.5 units on a scale | Standard Deviation 0.7 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 8 | 2.1 units on a scale | Standard Deviation 0.8 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 12 | 1.7 units on a scale | Standard Deviation 0.9 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 16 | 1.8 units on a scale | Standard Deviation 1 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 20 | 1.7 units on a scale | Standard Deviation 1 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) at Each Visit | Week 24 | 1.8 units on a scale | Standard Deviation 1 |
Secondary
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).
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Population: Primary analysis set participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 2.57 units on a scale | Standard Deviation 0.11 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 2.23 units on a scale | Standard Deviation 0.14 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 1.68 units on a scale | Standard Deviation 0.14 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 1.73 units on a scale | Standard Deviation 0.14 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 1.63 units on a scale | Standard Deviation 0.15 |
| Etanercept 50 mg | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 1.73 units on a scale | Standard Deviation 0.16 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 20 (n = 38, 19) | 1.63 units on a scale | Standard Deviation 0.22 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 4 (n = 42, 21) | 2.29 units on a scale | Standard Deviation 0.12 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 16 (n = 37, 19) | 1.74 units on a scale | Standard Deviation 0.23 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 8 (n = 39, 21) | 1.71 units on a scale | Standard Deviation 0.14 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 24 (n = 37, 18) | 1.83 units on a scale | Standard Deviation 0.23 |
| Anti-adalimumab Antibody Negative | Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit | Week 12 (n = 40, 20) | 1.55 units on a scale | Standard Deviation 0.18 |