Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.

PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.

PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.

PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.

Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).

PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.

Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.

SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.

SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.

PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.

Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.

DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).

WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).

MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.

MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.

As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.

As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.

As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.

As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.