Plaque Psoriasis
Conditions
Brief summary
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
Detailed description
This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.
Interventions
DRUGEtanercept
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
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
* Subject has provided informed consent prior to initiation of any study specific activities/procedures * Male or female subject is ≥ 18 years of age at time of screening * Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator * Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline * Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening * Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator * Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast) * Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment * Subject is \< 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody * Subject has no known history of tuberculosis.
Exclusion criteria
Skin disease related -Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO. Other Medical Conditions * Subject has one or more significant concurrent medical conditions per investigator judgment, including the following * Poorly controlled diabetes * Chronic kidney disease stage IIIb, IV, or V * Symptomatic heart failure (New York Heart Association class II, III, or IV) * Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization * Uncontrolled hypertension * Severe chronic pulmonary disease (eg, requiring oxygen therapy) * Multiple sclerosis or any other demyelinating disease * Liver disease * Anemia * Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome) * Subject has active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a PASI 75 Response at Week 12 | Baseline and week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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. |
| Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) 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). 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, 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. |
| 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). |
| Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | 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. |
| Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis. |
| PSI Itch From Psoriasis Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| 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. |
| PSI Scaling of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| PSI Burning of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| PSI Stinging of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| PSI Cracking of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| PSI Flaking of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| PSI Pain From Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
| Patient Assessment of Treatment Satisfaction 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 Assessment of Treatment Satisfaction 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. |
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24 | 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). Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement. |
| Number of Participants With Adverse Events | From first dose of etanercept to 30 days after last dose, up to 28 weeks. | — |
| PSI Redness of Skin Lesions Component Score at Each Visit | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 | Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 22 centers in the United States from 18 May 2016 to 06 December 2017.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 14.8 |
| Age, Customized < 65 years | 63 Participants |
| Age, Customized ≥ 65 years | 17 Participants |
| Dermatology Life Quality Index (DLQI) | 12.5 units on a scale STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Patient Assessment of Treatment Satisfaction Dissatisfied | 13 Participants |
| Patient Assessment of Treatment Satisfaction Neither satisfied nor dissatisfied | 30 Participants |
| Patient Assessment of Treatment Satisfaction Satisfied | 4 Participants |
| Patient Assessment of Treatment Satisfaction Very dissatisfied | 33 Participants |
| Patient Assessment of Treatment Satisfaction Very satisfied | 0 Participants |
| Percent of Body Surface Area (BSA) Involved in Psoriasis | 16.4 Percentage of BSA STANDARD_DEVIATION 10.5 |
| Psoriasis Area Severity Index (PASI) Score | 16.4 units on a scale STANDARD_DEVIATION 6.5 |
| Psoriasis Symptom Inventory (PSI) Burning of skin lesions | 1.4 units on a scale STANDARD_DEVIATION 1.2 |
| Psoriasis Symptom Inventory (PSI) Cracking of skin lesions | 2.0 units on a scale STANDARD_DEVIATION 1 |
| Psoriasis Symptom Inventory (PSI) Flaking of skin lesions | 2.5 units on a scale STANDARD_DEVIATION 1.9 |
| Psoriasis Symptom Inventory (PSI) Itch from psoriasis | 2.5 units on a scale STANDARD_DEVIATION 1 |
| Psoriasis Symptom Inventory (PSI) Pain from skin lesions | 1.5 units on a scale STANDARD_DEVIATION 1.1 |
| Psoriasis Symptom Inventory (PSI) Redness of skin lesions | 2.6 units on a scale STANDARD_DEVIATION 0.9 |
| Psoriasis Symptom Inventory (PSI) Scaling of skin lesions | 2.6 units on a scale STANDARD_DEVIATION 0.8 |
| Psoriasis Symptom Inventory (PSI) Stinging of skin lesions | 1.5 units on a scale STANDARD_DEVIATION 1.2 |
| Psoriasis Symptom Inventory (PSI) Total score | 16.6 units on a scale STANDARD_DEVIATION 6.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 60 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 47 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 | 51 Participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 4 = Severe | 28 Participants |
| Static Physician Global Assessment (sPGA) of Psoriasis 5 = Very Severe | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 18 / 80 |
| serious Total, serious adverse events | 2 / 80 |
Outcome results
Primary
Percentage of Participants With a PASI 75 Response at Week 12
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 week 12
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used for participants with missing data at week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants With a PASI 75 Response at Week 12 | 41.6 percentage of participants |
Secondary
Number of Participants With Adverse Events
Time frame: From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Population: Participants who received at least 1 dose of etanercept during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events | All adverse events (AEs) | 19 Participants |
| Etanercept | Number of Participants With Adverse Events | Serious adverse events | 2 Participants |
| Etanercept | Number of Participants With Adverse Events | AEs leading to discontinuation of etanercept | 2 Participants |
| Etanercept | Number of Participants With Adverse Events | Fatal adverse events | 0 Participants |
| Etanercept | Number of Participants With Adverse Events | Treatment-related adverse events (TRAEs) | 10 Participants |
| Etanercept | Number of Participants With Adverse Events | Treatment-related serious adverse events | 1 Participants |
| Etanercept | Number of Participants With Adverse Events | TRAEs leading to discontinuation of etanercept | 1 Participants |
| Etanercept | Number of Participants With Adverse Events | Fatal treatment-related adverse events | 0 Participants |
Secondary
Patient Assessment of Treatment Satisfaction 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 12 | Very dissatisfied | 4.1 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 12 | Dissatisfied | 13.5 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 12 | Neither satisfied nor dissatisfied | 21.6 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 12 | Satisfied | 32.4 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 12 | Very satisfied | 28.4 percentage of participants |
Secondary
Patient Assessment of Treatment Satisfaction 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 24 | Very dissatisfied | 8.0 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 24 | Dissatisfied | 25.3 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 24 | Neither satisfied nor dissatisfied | 13.3 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 24 | Satisfied | 24.0 percentage of participants |
| Etanercept | Patient Assessment of Treatment Satisfaction at Week 24 | Very satisfied | 29.3 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 16 | 59.7 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 20 | 55.8 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 4 | 21.1 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 8 | 55.8 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 12 | 62.3 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit | Week 24 | 57.1 percentage of participants |
Secondary
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) 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). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 4 | 3.9 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 8 | 15.6 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 12 | 23.4 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 16 | 28.6 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 20 | 29.9 percentage of participants |
| Etanercept | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 24 | 33.8 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 4 | 23.7 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 8 | 50.6 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 12 | 70.1 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 16 | 68.8 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 20 | 74.0 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 50 Response at Each Visit | Week 24 | 62.3 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 4 | 6.6 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 8 | 23.4 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 12 | 41.6 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 16 | 42.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 20 | 42.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response at Each Visit | Week 24 | 45.5 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 4 | 1.3 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 8 | 6.5 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 12 | 13.0 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 16 | 16.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 20 | 23.4 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response at Each Visit | Week 24 | 22.1 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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 4 | 40.8 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 8 | 70.1 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 12 | 75.3 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 16 | 72.7 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 20 | 74.0 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline | Week 24 | 74.0 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: Participants who received at least 1 dose of etanercept during the study and with at least I post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 4 | 7.9 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 8 | 31.2 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 12 | 32.5 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 16 | 37.7 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 20 | 36.4 percentage of participants |
| Etanercept | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline | Week 24 | 39.0 percentage of participants |
Secondary
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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). 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 12 and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24 | Week 12 | 53.60 percent change | Standard Deviation 35.46 |
| Etanercept | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24 | Week 24 | 36.95 percent change | Standard Deviation 92.77 |
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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 4 | 22.03 percent change | Standard Deviation 33.58 |
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 8 | 43.51 percent change | Standard Deviation 40.53 |
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 12 | 55.47 percent change | Standard Deviation 48.16 |
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 16 | 57.41 percent change | Standard Deviation 40.79 |
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 20 | 60.42 percent change | Standard Deviation 39.12 |
| Etanercept | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) | Week 24 | 57.67 percent change | Standard Deviation 40.2 |
Secondary
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 4 | 13.47 percent change | Standard Deviation 24.63 |
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 8 | 31.03 percent change | Standard Deviation 37.52 |
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 12 | 44.49 percent change | Standard Deviation 40.29 |
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 16 | 48.26 percent change | Standard Deviation 39.8 |
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 20 | 49.97 percent change | Standard Deviation 40.15 |
| Etanercept | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit | Week 24 | 46.89 percent change | Standard Deviation 42.7 |
Secondary
PSI Burning of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 1 | 1.3 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 2 | 1.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 3 | 1.0 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 4 | 1.0 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 8 | 0.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 12 | 0.8 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 16 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 20 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Burning of Skin Lesions Component Score at Each Visit | Week 24 | 0.9 units on a scale | Standard Deviation 1.1 |
Secondary
PSI Cracking of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 1 | 1.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 2 | 1.7 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 3 | 1.6 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 4 | 1.4 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 8 | 1.2 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 12 | 1.1 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 16 | 1.2 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 20 | 1.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Cracking of Skin Lesions Component Score at Each Visit | Week 24 | 1.2 units on a scale | Standard Deviation 1.1 |
Secondary
PSI Flaking of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 1 | 2.2 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 2 | 2.1 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 3 | 1.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 4 | 1.8 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 8 | 1.5 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 12 | 1.3 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 16 | 1.5 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 20 | 1.6 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Flaking of Skin Lesions Component Score at Each Visit | Week 24 | 1.4 units on a scale | Standard Deviation 1.1 |
Secondary
PSI Itch From Psoriasis Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 1 | 2.2 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 2 | 2.0 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 3 | 1.9 units on a scale | Standard Deviation 0.8 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 4 | 1.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 8 | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 12 | 1.3 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 16 | 1.5 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 20 | 1.5 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Itch From Psoriasis Component Score at Each Visit | Week 24 | 1.5 units on a scale | Standard Deviation 1 |
Secondary
PSI Pain From Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 1 | 1.2 units on a scale | Standard Deviation 1.2 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 2 | 1.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 3 | 1.0 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 4 | 1.0 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 8 | 0.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 12 | 0.7 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 16 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 20 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Pain From Skin Lesions Component Score at Each Visit | Week 24 | 0.8 units on a scale | Standard Deviation 1 |
Secondary
PSI Redness of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 1 | 2.4 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 2 | 2.2 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 3 | 2.0 units on a scale | Standard Deviation 0.8 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 4 | 1.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 8 | 1.7 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 12 | 1.5 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 16 | 1.7 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 20 | 1.5 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Redness of Skin Lesions Component Score at Each Visit | Week 24 | 1.5 units on a scale | Standard Deviation 1.1 |
Secondary
PSI Scaling of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 2 | 2.1 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 3 | 1.9 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 4 | 1.9 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 8 | 1.6 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 12 | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 1 | 2.3 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 16 | 1.6 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 20 | 1.6 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Scaling of Skin Lesions Component Score at Each Visit | Week 24 | 1.4 units on a scale | Standard Deviation 1.1 |
Secondary
PSI Stinging of Skin Lesions Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 1 | 1.2 units on a scale | Standard Deviation 1.2 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 2 | 1.1 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 3 | 1.0 units on a scale | Standard Deviation 1 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 4 | 1.0 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 8 | 0.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 12 | 0.7 units on a scale | Standard Deviation 0.9 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 16 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 20 | 0.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | PSI Stinging of Skin Lesions Component Score at Each Visit | Week 24 | 0.8 units on a scale | Standard Deviation 1.1 |
Secondary
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 1 | 14.7 units on a scale | Standard Deviation 7.1 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 2 | 13.7 units on a scale | Standard Deviation 6.5 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 3 | 12.1 units on a scale | Standard Deviation 6.1 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 4 | 11.7 units on a scale | Standard Deviation 6.6 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 8 | 10.0 units on a scale | Standard Deviation 5.9 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 12 | 8.8 units on a scale | Standard Deviation 6.4 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 16 | 10.1 units on a scale | Standard Deviation 7.6 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 20 | 9.9 units on a scale | Standard Deviation 7.8 |
| Etanercept | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit | Week 24 | 9.6 units on a scale | Standard Deviation 7.7 |
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: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 4 | 2.9 units on a scale | Standard Deviation 0.7 |
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 8 | 2.4 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 12 | 2.2 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 16 | 2.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 20 | 2.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | Static Physician Global Assessment (sPGA) at Each Visit | Week 24 | 2.2 units on a scale | Standard Deviation 1.2 |