Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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).