Pediatric Plaque Psoriasis
Conditions
Keywords
Immunex, Amgen, Pediatric,, plaque psoriasis, clinical trial
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Detailed description
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).
Interventions
DRUGEtanercept
Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Enrollment on previous Amgen study 20030211 (NCT00078819)
Exclusion criteria
* Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 264 Weeks | A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exposure-adjusted Adverse Event Rates | 264 weeks | The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period. Exposure-adjusted event rate per 100 patient years = total number of events / patient years \* 100. Multiple occurrences of the same event for a participant were counted as multiple events. |
| Number of Participants With Clinically Significant Changes in Vital Signs | 264 weeks | — |
| Number of Participants With Grade 3 and 4 Laboratory Toxicities | 264 weeks | The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal. |
| Number of Participants Who Developed Anti-etanercept Antibodies | 264 weeks | Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay. Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline. |
| Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 | 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Percentage of Participants With a PASI 75 Response | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 | 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Percentage of Participants With a PASI 90 Response | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 | 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Percent Improvement From Study 20030211 Baseline in PASI Score | Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264 | 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Number of Participants With Injection Site Reactions | 264 weeks | An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer. |
| Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but \< 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 | The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100. |
| Improvement From Study 20030211 Baseline in Joint Pain | Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264 | Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10). Improvement from baseline = (Baseline Value - Post-baseline Value). |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Weeks 12, 48, 96, 144, 192, 240 and 264 | 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). |
Participant flow
Recruitment details
This study was designed to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe plaque psoriasis who participated in Study 20030211 (NCT00078819). The study was conducted at 38 sites in the United States and Canada.
Pre-assignment details
Results reported below are from the main analysis performed at year 5 (264 weeks).
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. | 182 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Decision | 2 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Disease Progression | 7 |
| Overall Study | Ineligibility Determined | 2 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Noncompliance | 17 |
| Overall Study | Other | 8 |
| Overall Study | Pregnancy | 4 |
| Overall Study | Protocol Deviation | 7 |
| Overall Study | Remain on Study | 28 |
| Overall Study | Withdrawal by Subject | 42 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 12.8 years STANDARD_DEVIATION 3.5 |
| Race/Ethnicity, Customized Asian | 13 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 17 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Race/Ethnicity, Customized White or Caucasian | 138 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 148 / 181 |
| serious Total, serious adverse events | 7 / 181 |
Outcome results
Primary
Number of Participants With Adverse Events
A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Time frame: 264 Weeks
Population: Participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events | Any adverse event | 161 participants |
| Etanercept | Number of Participants With Adverse Events | Non-infectious adverse events | 149 participants |
| Etanercept | Number of Participants With Adverse Events | Infections | 140 participants |
| Etanercept | Number of Participants With Adverse Events | Grade 3 non-infectious adverse events | 14 participants |
| Etanercept | Number of Participants With Adverse Events | Grade 3 infections | 5 participants |
| Etanercept | Number of Participants With Adverse Events | Serious non-infectious adverse events | 5 participants |
| Etanercept | Number of Participants With Adverse Events | Serious infections | 2 participants |
| Etanercept | Number of Participants With Adverse Events | Non-infectious AEs leading to study withdrawal | 5 participants |
| Etanercept | Number of Participants With Adverse Events | Infections leading to withdrawal from study | 1 participants |
| Etanercept | Number of Participants With Adverse Events | Injection site reactions | 16 participants |
| Etanercept | Number of Participants With Adverse Events | Deaths | 0 participants |
Secondary
Exposure-adjusted Adverse Event Rates
The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period. Exposure-adjusted event rate per 100 patient years = total number of events / patient years \* 100. Multiple occurrences of the same event for a participant were counted as multiple events.
Time frame: 264 weeks
Population: Participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Exposure-adjusted Adverse Event Rates | All adverse events | 215.8 events per 100 patient years |
| Etanercept | Exposure-adjusted Adverse Event Rates | Non-infectious Adverse Events | 115.9 events per 100 patient years |
| Etanercept | Exposure-adjusted Adverse Event Rates | Infections | 97.3 events per 100 patient years |
| Etanercept | Exposure-adjusted Adverse Event Rates | Injection Site Reactions | 2.6 events per 100 patient years |
Secondary
Improvement From Study 20030211 Baseline in Joint Pain
Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10). Improvement from baseline = (Baseline Value - Post-baseline Value).
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
Population: Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Study 20050111 baseline (N = 31) | 1.5 units on a scale | Standard Deviation 2.7 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 12 (N = 29) | 2.3 units on a scale | Standard Deviation 2.5 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 24 (N = 22) | 2.4 units on a scale | Standard Deviation 3.2 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 36 (N = 22) | 1.5 units on a scale | Standard Deviation 3.2 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 48 (N = 24) | 1.5 units on a scale | Standard Deviation 3.5 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 60 (N = 14) | 1.3 units on a scale | Standard Deviation 3.2 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 72 (N = 16) | 2.1 units on a scale | Standard Deviation 3.6 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 84 (N = 14) | 2.9 units on a scale | Standard Deviation 3 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 96 (N = 16) | 2.0 units on a scale | Standard Deviation 2.7 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 108 (N = 14) | 2.4 units on a scale | Standard Deviation 3.4 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 120 (N = 12) | 2.4 units on a scale | Standard Deviation 2.9 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 132 (N = 15) | 1.9 units on a scale | Standard Deviation 3.7 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 144 (N = 12) | 1.8 units on a scale | Standard Deviation 4.3 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 156 (N = 12) | 2.5 units on a scale | Standard Deviation 3.8 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 168 (N = 10) | 2.2 units on a scale | Standard Deviation 4 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 180 (N = 11) | 2.7 units on a scale | Standard Deviation 3.3 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 192 (N = 11) | 2.5 units on a scale | Standard Deviation 4.2 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 204 (N = 11) | 2.8 units on a scale | Standard Deviation 3.6 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 216 (N = 9) | 2.9 units on a scale | Standard Deviation 3.4 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 228 (N = 10) | 2.8 units on a scale | Standard Deviation 3.6 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 240 (N = 9) | 2.7 units on a scale | Standard Deviation 3.4 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 252 (N = 8) | 3.9 units on a scale | Standard Deviation 3.7 |
| Etanercept | Improvement From Study 20030211 Baseline in Joint Pain | Week 264 (N = 8) | 3.9 units on a scale | Standard Deviation 3.3 |
Secondary
Number of Participants Who Developed Anti-etanercept Antibodies
Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay. Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline.
Time frame: 264 weeks
Population: Participants who received at least one dose of investigational product and had a post-baseline antibody result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants Who Developed Anti-etanercept Antibodies | Binding antibody positive | 18 participants |
| Etanercept | Number of Participants Who Developed Anti-etanercept Antibodies | Neutralizing antibody positive | 0 participants |
Secondary
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: 264 weeks
Population: Participants who received at least one dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants With Clinically Significant Changes in Vital Signs | 0 participants |
Secondary
Number of Participants With Grade 3 and 4 Laboratory Toxicities
The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.
Time frame: 264 weeks
Population: Participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Any grade 4 toxicity | 0 participants |
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Grade 3 high creatinine | 1 participants |
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Grade 3 high hemoglobin | 1 participants |
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Grade 3 low hemoglobin | 1 participants |
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Grade 3 high alanine aminotransferase | 1 participants |
| Etanercept | Number of Participants With Grade 3 and 4 Laboratory Toxicities | Grade 3 high white blood cells | 1 participants |
Secondary
Number of Participants With Injection Site Reactions
An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Time frame: 264 weeks
Population: Participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Injection Site Reactions | Any injection site reaction | 16 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site erythema | 6 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site reaction | 4 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site pruritus | 3 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site haematoma | 2 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site swelling | 2 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site discolouration | 1 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site irritation | 1 participants |
| Etanercept | Number of Participants With Injection Site Reactions | Injection site pain | 1 participants |
Secondary
Percentage of Participants With a PASI 75 Response
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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Population: Participants who received at least one dose of investigational product with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 12 (N = 181) | 67.4 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 48 (N = 168) | 67.3 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 96 (N = 138) | 60.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 144 (N = 114) | 62.3 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 192 (n = 92) | 69.6 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 240 (N = 74) | 64.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 75 Response | Week 264 (N = 66) | 63.6 percentage of participants |
Secondary
Percentage of Participants With a PASI 90 Response
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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Population: Participants who received at least one dose of investigational product with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 12 (N = 181) | 35.4 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 48 (N = 168) | 32.7 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 96 (N = 138) | 29.7 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 144 (N = 114) | 28.1 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 192 (n = 92) | 35.9 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 240 (N = 74) | 36.5 percentage of participants |
| Etanercept | Percentage of Participants With a PASI 90 Response | Week 264 (N = 66) | 28.8 percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Population: Participants who received at least one dose of investigational product and with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 12 (N = 181) | 89.5 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 48 (N = 168) | 89.3 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 96 (N = 138) | 89.1 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 144 (N = 114) | 88.6 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 192 (n = 92) | 87.0 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 240 (N = 74) | 91.9 percentage of participants |
| Etanercept | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | Week 264 (N = 66) | 87.9 percentage of participants |
Secondary
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
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 12, 48, 96, 144, 192, 240 and 264
Population: Participants who received at least one dose of investigational product with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 12 (N = 181) | 53.6 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 48 (N = 168) | 48.8 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 96 (N = 139) | 47.5 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 144 (N = 114) | 45.6 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 192 (n = 92) | 47.8 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 240 (N = 74) | 50.0 percentage of participants |
| Etanercept | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | Week 264 (N = 66) | 37.9 percentage of participants |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Study 20050111 baseline (N = 165) | 51.088 percent improvement | Standard Deviation 52.612 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 24 (N = 156) | 50.546 percent improvement | Standard Deviation 58.606 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 48 (N = 148) | 51.792 percent improvement | Standard Deviation 61.204 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 72 (N = 136) | 50.792 percent improvement | Standard Deviation 70.769 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 96 (N = 129) | 48.686 percent improvement | Standard Deviation 68.482 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 120 (N = 105) | 59.031 percent improvement | Standard Deviation 49.472 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 144 (N = 104) | 57.125 percent improvement | Standard Deviation 54.284 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 168 (N = 94) | 55.198 percent improvement | Standard Deviation 52.141 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 192 (N = 81) | 47.989 percent improvement | Standard Deviation 72.947 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 216 (N = 71) | 58.545 percent improvement | Standard Deviation 60.44 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 240 (N = 64) | 55.727 percent improvement | Standard Deviation 64.42 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | Week 264 (N = 56) | 50.072 percent improvement | Standard Deviation 62.049 |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Study 20050111 baseline (N = 166) | 45.452 percent improvement | Standard Deviation 65.038 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 24 (N = 156) | 49.797 percent improvement | Standard Deviation 59.328 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 48 (N = 149) | 50.895 percent improvement | Standard Deviation 60.179 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 72 (N = 136) | 54.669 percent improvement | Standard Deviation 54.519 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 96 (N = 129) | 48.346 percent improvement | Standard Deviation 60.414 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 120 (N = 105) | 51.206 percent improvement | Standard Deviation 54.435 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 144 (N = 105) | 50.365 percent improvement | Standard Deviation 49.636 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 168 (N = 94) | 44.557 percent improvement | Standard Deviation 72.287 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 192 (N = 81) | 52.284 percent improvement | Standard Deviation 56.125 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 216 (N = 71) | 61.737 percent improvement | Standard Deviation 48.255 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 240 (N = 65) | 56.282 percent improvement | Standard Deviation 52.042 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | Week 264 (N = 57) | 56.140 percent improvement | Standard Deviation 52.481 |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Study 20050111 baseline (N = 165) | 31.616 percent improvement | Standard Deviation 51.981 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 24 (N = 156) | 32.585 percent improvement | Standard Deviation 52.75 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 48 (N = 148) | 36.149 percent improvement | Standard Deviation 51.778 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 72 (N = 133) | 29.825 percent improvement | Standard Deviation 53.025 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 96 (N = 129) | 29.457 percent improvement | Standard Deviation 55.805 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 120 (N = 105) | 32.063 percent improvement | Standard Deviation 55.166 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 144 (N = 105) | 33.333 percent improvement | Standard Deviation 48.371 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 168 (N = 94) | 32.979 percent improvement | Standard Deviation 50.563 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 192 (N = 81) | 31.070 percent improvement | Standard Deviation 52.886 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 216 (N = 71) | 35.211 percent improvement | Standard Deviation 48.103 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 240 (N = 65) | 26.923 percent improvement | Standard Deviation 56.649 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | Week 264 (N = 57) | 27.193 percent improvement | Standard Deviation 51.815 |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Study 20050111 baseline (N = 161) | 36.646 percent improvement | Standard Deviation 56.851 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 24 (N = 153) | 36.057 percent improvement | Standard Deviation 60.349 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 48 (N = 144) | 31.597 percent improvement | Standard Deviation 56.329 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 72 (N = 132) | 34.596 percent improvement | Standard Deviation 57.39 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 96 (N = 127) | 32.940 percent improvement | Standard Deviation 55.216 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 120 (N = 101) | 29.538 percent improvement | Standard Deviation 61.503 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 144 (N = 102) | 41.013 percent improvement | Standard Deviation 50.229 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 168 (N = 93) | 37.814 percent improvement | Standard Deviation 49.888 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 192 (N = 81) | 34.774 percent improvement | Standard Deviation 54.658 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 216 (N = 71) | 35.681 percent improvement | Standard Deviation 50.811 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 240 (N = 65) | 39.231 percent improvement | Standard Deviation 48.808 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | Week 264 (N = 56) | 36.012 percent improvement | Standard Deviation 57.89 |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Study 20050111 baseline (N = 165) | 54.869 percent improvement | Standard Deviation 56.213 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 24 (N = 155) | 55.366 percent improvement | Standard Deviation 64.039 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 48 (N = 149) | 53.792 percent improvement | Standard Deviation 65.857 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 72 (N = 136) | 51.005 percent improvement | Standard Deviation 68.117 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 96 (N = 128) | 55.430 percent improvement | Standard Deviation 57.43 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 120 (N = 105) | 53.302 percent improvement | Standard Deviation 67.555 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 144 (N = 104) | 56.250 percent improvement | Standard Deviation 58.194 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 168 (N = 94) | 58.901 percent improvement | Standard Deviation 49.431 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 192 (N = 81) | 55.700 percent improvement | Standard Deviation 56.352 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 216 (N = 71) | 71.056 percent improvement | Standard Deviation 41.396 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 240 (N = 65) | 67.538 percent improvement | Standard Deviation 43.418 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | Week 264 (N = 57) | 56.725 percent improvement | Standard Deviation 52.965 |
Secondary
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Study 20050111 baseline (N = 161) | 23.085 percent improvement | Standard Deviation 64.713 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 24 (N = 152) | 13.268 percent improvement | Standard Deviation 74.987 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 48 (N = 144) | 18.634 percent improvement | Standard Deviation 67.75 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 72 (N = 134) | 23.383 percent improvement | Standard Deviation 73.21 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 96 (N = 128) | 17.969 percent improvement | Standard Deviation 72.561 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 120 (N = 105) | 17.778 percent improvement | Standard Deviation 65.709 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 144 (N = 104) | 21.795 percent improvement | Standard Deviation 62.924 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 168 (N = 93) | 20.430 percent improvement | Standard Deviation 73.849 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 192 (N = 81) | 26.955 percent improvement | Standard Deviation 68.443 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 216 (N = 71) | 31.455 percent improvement | Standard Deviation 59.598 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 240 (N = 65) | 30.513 percent improvement | Standard Deviation 57.703 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | Week 264 (N = 56) | 37.500 percent improvement | Standard Deviation 64.842 |
Secondary
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but \< 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Population: Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Study 20050111 baseline (N = 164) | 59.492 percent improvement | Standard Deviation 73.501 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 24 (N = 155) | 54.978 percent improvement | Standard Deviation 69.744 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 48 (N = 148) | 59.229 percent improvement | Standard Deviation 65.259 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 72 (N = 136) | 57.549 percent improvement | Standard Deviation 79.389 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 96 (N = 127) | 61.084 percent improvement | Standard Deviation 66.169 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 120 (N = 105) | 64.059 percent improvement | Standard Deviation 75.298 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 144 (N = 103) | 69.732 percent improvement | Standard Deviation 42.008 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 168 (N = 93) | 67.531 percent improvement | Standard Deviation 42.261 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 192 (N = 81) | 65.622 percent improvement | Standard Deviation 53.359 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 216 (N = 70) | 76.121 percent improvement | Standard Deviation 43.217 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 240 (N = 64) | 73.631 percent improvement | Standard Deviation 54.704 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | Week 264 (N = 56) | 63.291 percent improvement | Standard Deviation 63.555 |
Secondary
Percent Improvement From Study 20030211 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Population: Participants who received at least one dose of investigational product with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Study 20050111 baseline (N = 179) | 74.429 percent improvement | Standard Deviation 22.146 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 12 (N = 181) | 78.286 percent improvement | Standard Deviation 21.079 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 48 (N = 168) | 77.546 percent improvement | Standard Deviation 20.682 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 96 (N = 138) | 75.355 percent improvement | Standard Deviation 24.139 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 144 (N = 114) | 75.052 percent improvement | Standard Deviation 23.839 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 192 (n = 92) | 77.815 percent improvement | Standard Deviation 23.965 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 240 (N = 74) | 78.924 percent improvement | Standard Deviation 23.497 |
| Etanercept | Percent Improvement From Study 20030211 Baseline in PASI Score | Week 264 (N = 66) | 74.605 percent improvement | Standard Deviation 29.327 |