Plaque Psoriasis, Psoriasis
Conditions
Keywords
Enbrel, Psoriasis, Topical Psoriasis, Wyeth Psoriasis, Active Psoriasis
Brief summary
The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.
Interventions
DRUGEtanercept
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older at time of consent. * Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10. * In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.
Exclusion criteria
* Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. * Active or recent (within 2 years) tuberculosis (TB) infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 | Week 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Baseline to Week 24 | 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). |
| Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Baseline to week 24 | 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). |
| Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Baseline to Week 24 | 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). |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Baseline to Week 24 | 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 to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | Baseline to Week 24 | 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. |
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Baseline to Week 24 | 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). |
| Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | Baseline to Week 24 | 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). |
| Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Baseline to Week 24 | — |
| Change From Baseline in the Photographed Image of Lesions in Selected Participants | Baseline to Week 24 | 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. |
| Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | From Week 12 to Week 24 | 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. |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | 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. |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Week 24 | 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. |
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Emergency Room Visits | Week 12 and Week 24 | As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No. |
| Mean Number of Emergency Room Days | Week 12 and Week 24 | As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized. |
| Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Mean Number of Doctor Visits | Week 12 and Week 24 | As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized. |
| Percentage of Participants With Doctor Visits | Week 12 and Week 24 | As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No. |
| Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12 | Baseline, Week 12 | 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. |
| Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Baseline to Week 24 | 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. |
| Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Baseline to Week 24 | 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. |
| Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Baseline to Week 24 | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Baseline to Week 24 | 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). |
| Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | Baseline, Week 12 and Week 24 | 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. |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Baseline, Week 12 and Week 24 | 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. |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | Baseline, Week 12 and Week 24 | 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. |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Week 12 | 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 \[completely prevented from working\]). |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Week 24 | 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 \[completely prevented from working\]). |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Week 12 | 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. |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Week 24 | 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. |
| Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | Week 12 and Week 24 | 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. |
Countries
Argentina, Austria, Belgium, Czechia, Germany, Greece, Hungary, Italy, Mexico, South Korea, Spain, Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ETN 50 mg BW/QW Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase). | 136 |
| ETN 50 mg QW/QW ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase). | 137 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 |
| Overall Study | Discontinuation of Study by Sponsor | 2 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unsatisfactory Response - Efficacy | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | ETN 50 mg BW/QW | Total | ETN 50 mg QW/QW |
|---|---|---|---|
| Age Continuous | 43.95 Years STANDARD_DEVIATION 12.68 | 43.90 Years STANDARD_DEVIATION 12.66 | 43.85 Years STANDARD_DEVIATION 12.69 |
| Mean Dermatology Life Quality Index (DLQI) Total Score | 14.1 Units on scale STANDARD_DEVIATION 7.3 | 14.6 Units on scale STANDARD_DEVIATION 7.7 | 15.0 Units on scale STANDARD_DEVIATION 8 |
| Mean Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Scores | 0.65 Units on scale STANDARD_DEVIATION 0.3 | 0.65 Units on scale STANDARD_DEVIATION 0.31 | 0.66 Units on scale STANDARD_DEVIATION 0.31 |
| Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | 37.9 Units on scale STANDARD_DEVIATION 10 | 37.3 Units on scale STANDARD_DEVIATION 10.4 | 36.7 Units on scale STANDARD_DEVIATION 10.8 |
| Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores HADS Anxiety Score | 7.2 Units on scale STANDARD_DEVIATION 4.4 | 7.0 Units on scale STANDARD_DEVIATION 4.3 | 6.9 Units on scale STANDARD_DEVIATION 4.1 |
| Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores HADS Depression Score | 6.0 Units on scale STANDARD_DEVIATION 4.1 | 6.2 Units on scale STANDARD_DEVIATION 4.1 | 6.5 Units on scale STANDARD_DEVIATION 4.1 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Adequacy | 54.6 Units on scale STANDARD_DEVIATION 25.9 | 54.3 Units on scale STANDARD_DEVIATION 26.6 | 54.0 Units on scale STANDARD_DEVIATION 27.3 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Disturbance | 35.0 Units on scale STANDARD_DEVIATION 23.6 | 34.7 Units on scale STANDARD_DEVIATION 23.6 | 34.4 Units on scale STANDARD_DEVIATION 23.8 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Problem Index I | 32.5 Units on scale STANDARD_DEVIATION 18.7 | 32.7 Units on scale STANDARD_DEVIATION 18.9 | 32.9 Units on scale STANDARD_DEVIATION 19.1 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Problem Index II | 33.9 Units on scale STANDARD_DEVIATION 18.2 | 34.0 Units on scale STANDARD_DEVIATION 18.9 | 34.2 Units on scale STANDARD_DEVIATION 19.6 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Quantity | 6.9 Units on scale STANDARD_DEVIATION 1.4 | 6.9 Units on scale STANDARD_DEVIATION 1.4 | 6.9 Units on scale STANDARD_DEVIATION 1.4 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Short of Breath or Headache | 13.2 Units on scale STANDARD_DEVIATION 20.4 | 13.8 Units on scale STANDARD_DEVIATION 20.5 | 14.3 Units on scale STANDARD_DEVIATION 20.7 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Snoring | 37.9 Units on scale STANDARD_DEVIATION 29.6 | 41.9 Units on scale STANDARD_DEVIATION 30.5 | 45.7 Units on scale STANDARD_DEVIATION 31 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Somnolence | 29.9 Units on scale STANDARD_DEVIATION 19.9 | 30.4 Units on scale STANDARD_DEVIATION 19.5 | 30.9 Units on scale STANDARD_DEVIATION 19.3 |
| Mean Number of Doctor Visits | 2.9 Visits STANDARD_DEVIATION 3.36 | 3.0 Visits STANDARD_DEVIATION 3.51 | 3.0 Visits STANDARD_DEVIATION 3.68 |
| Mean Number of Emergency Room Days | 7.8 Days STANDARD_DEVIATION 5.64 | 8.7 Days STANDARD_DEVIATION 6.45 | 9.4 Days STANDARD_DEVIATION 7.31 |
| Mean Psoriasis Area and Severity Index (PASI) Score | 21.4 Units on scale STANDARD_DEVIATION 9.4 | 21.2 Units on scale STANDARD_DEVIATION 9.4 | 20.9 Units on scale STANDARD_DEVIATION 9.4 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Anxiety | 1.8 Units on scale STANDARD_DEVIATION 1.1 | 1.7 Units on scale STANDARD_DEVIATION 1.1 | 1.7 Units on scale STANDARD_DEVIATION 1.1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Burning sensation in the skin | 1.5 Units on scale STANDARD_DEVIATION 1.1 | 1.5 Units on scale STANDARD_DEVIATION 1.1 | 1.5 Units on scale STANDARD_DEVIATION 1.1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Comfort level with your appearance | 1.3 Units on scale STANDARD_DEVIATION 1.1 | 1.3 Units on scale STANDARD_DEVIATION 1 | 1.2 Units on scale STANDARD_DEVIATION 1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Depression | 2.0 Units on scale STANDARD_DEVIATION 1.1 | 1.9 Units on scale STANDARD_DEVIATION 1.1 | 1.9 Units on scale STANDARD_DEVIATION 1.1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Fatigue | 2.0 Units on scale STANDARD_DEVIATION 1 | 1.9 Units on scale STANDARD_DEVIATION 1 | 1.8 Units on scale STANDARD_DEVIATION 1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Flaking skin | 1.0 Units on scale STANDARD_DEVIATION 0.9 | 1.0 Units on scale STANDARD_DEVIATION 0.9 | 1.0 Units on scale STANDARD_DEVIATION 0.9 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores How others respond to your appearance | 1.6 Units on scale STANDARD_DEVIATION 1 | 1.7 Units on scale STANDARD_DEVIATION 1 | 1.8 Units on scale STANDARD_DEVIATION 1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores How your skin affects social, leisure activities | 1.5 Units on scale STANDARD_DEVIATION 1.2 | 1.4 Units on scale STANDARD_DEVIATION 1.1 | 1.3 Units on scale STANDARD_DEVIATION 1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Joint pain | 1.8 Units on scale STANDARD_DEVIATION 1.3 | 1.8 Units on scale STANDARD_DEVIATION 1.3 | 1.8 Units on scale STANDARD_DEVIATION 1.4 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Overall appearance of your skin | 0.9 Units on scale STANDARD_DEVIATION 0.8 | 0.9 Units on scale STANDARD_DEVIATION 0.9 | 0.9 Units on scale STANDARD_DEVIATION 0.9 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Satisfaction with psoriasis treatment in general | 1.4 Units on scale STANDARD_DEVIATION 1.2 | 1.4 Units on scale STANDARD_DEVIATION 1.1 | 1.4 Units on scale STANDARD_DEVIATION 1.1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin bleeding | 1.7 Units on scale STANDARD_DEVIATION 1 | 1.7 Units on scale STANDARD_DEVIATION 1.1 | 1.8 Units on scale STANDARD_DEVIATION 1.2 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin pain | 1.5 Units on scale STANDARD_DEVIATION 1.2 | 1.5 Units on scale STANDARD_DEVIATION 1.1 | 1.5 Units on scale STANDARD_DEVIATION 1.1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin redness | 1.1 Units on scale STANDARD_DEVIATION 0.9 | 1.0 Units on scale STANDARD_DEVIATION 0.9 | 1.0 Units on scale STANDARD_DEVIATION 0.9 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin tightness | 1.2 Units on scale STANDARD_DEVIATION 0.9 | 1.2 Units on scale STANDARD_DEVIATION 1 | 1.2 Units on scale STANDARD_DEVIATION 1 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Would like to continue with my current treatment | 2.0 Units on scale STANDARD_DEVIATION 1.6 | 2.1 Units on scale STANDARD_DEVIATION 1.6 | 2.2 Units on scale STANDARD_DEVIATION 1.6 |
| Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear (0) | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear/Almost Clear (0,1) | 0 Participants | 1 Participants | 1 Participants |
| Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear/Almost Clear/Mild (0,1,2) | 13 Participants | 30 Participants | 17 Participants |
| Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) Consider patient's condition satisfactory | 16 Participants | 32 Participants | 16 Participants |
| Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) Consider primary psoriasis therapy satisfactory | 15 Participants | 32 Participants | 17 Participants |
| Number of Participants Not Using Topical Preparations | 120 Participants | 244 Participants | 124 Participants |
| Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction Satisfaction with health state | 25 Participants | 53 Participants | 28 Participants |
| Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction Satisfaction with primary psoriasis treatment | 31 Participants | 59 Participants | 28 Participants |
| Number of Participants With Doctor Visits | 58 Participants | 119 Participants | 61 Participants |
| Number of Participants With Emergency Room Visits | 6 Participants | 14 Participants | 8 Participants |
| Percent Body Surface Area (BSA) of Involvement | 33.0 Percentage of BSA STANDARD_DEVIATION 19.4 | 33.0 Percentage of BSA STANDARD_DEVIATION 20.2 | 32.9 Percentage of BSA STANDARD_DEVIATION 21 |
| Sex: Female, Male Female | 47 Participants | 83 Participants | 36 Participants |
| Sex: Female, Male Male | 89 Participants | 190 Participants | 101 Participants |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Activity Impairment Due to Problem | 39.77 Percentage of indicated parameter STANDARD_DEVIATION 28.96 | 39.96 Percentage of indicated parameter STANDARD_DEVIATION 29.93 | 40.15 Percentage of indicated parameter STANDARD_DEVIATION 30.94 |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Impairment While Working Due to Problem | 24.36 Percentage of indicated parameter STANDARD_DEVIATION 23.28 | 25.27 Percentage of indicated parameter STANDARD_DEVIATION 25.29 | 26.09 Percentage of indicated parameter STANDARD_DEVIATION 27.08 |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Overall Work Impairment Due to Problem | 25.45 Percentage of indicated parameter STANDARD_DEVIATION 23.53 | 27.54 Percentage of indicated parameter STANDARD_DEVIATION 26.3 | 29.51 Percentage of indicated parameter STANDARD_DEVIATION 28.66 |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Work Time Missed | 3.60 Percentage of indicated parameter STANDARD_DEVIATION 16.14 | 5.45 Percentage of indicated parameter STANDARD_DEVIATION 17.67 | 7.19 Percentage of indicated parameter STANDARD_DEVIATION 18.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 97 / 136 | 91 / 137 |
| serious Total, serious adverse events | 3 / 136 | 4 / 137 |
Outcome results
Primary
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
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).
Time frame: Week 24
Population: Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 | 78.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 | 59.9 Percentage of participants |
Comparison: With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.p-value: 0.001595% CI: [6.8, 29.88]Fisher Exact
Secondary
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 20 | -25.4 Percentage of BSA | Standard Deviation 18.8 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 4 | -5.3 Percentage of BSA | Standard Deviation 10.1 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 16 | -23.8 Percentage of BSA | Standard Deviation 19.7 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 8 | -13.4 Percentage of BSA | Standard Deviation 15.2 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 24 | -25.9 Percentage of BSA | Standard Deviation 19.2 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 12 | -20.0 Percentage of BSA | Standard Deviation 19.2 |
| ETN 50 mg BW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 2 | -1.8 Percentage of BSA | Standard Deviation 7 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 12 | -12.7 Percentage of BSA | Standard Deviation 15.7 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 2 | -0.3 Percentage of BSA | Standard Deviation 6.7 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 16 | -15.9 Percentage of BSA | Standard Deviation 15.9 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 20 | -18.2 Percentage of BSA | Standard Deviation 16.3 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 24 | -19.0 Percentage of BSA | Standard Deviation 17.2 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 4 | -3.1 Percentage of BSA | Standard Deviation 7.7 |
| ETN 50 mg QW/QW | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Week 8 | -8.4 Percentage of BSA | Standard Deviation 11.8 |
Secondary
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 4 | -0.9 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 16 | -2.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 8 | -1.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 20 | -2.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 12 | -1.9 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 24 | -2.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 2 | -0.4 Units on scale | Standard Error 0 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 24 | -1.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 2 | -0.3 Units on scale | Standard Error 0 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 8 | -1.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 4 | -0.7 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 12 | -1.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 16 | -1.7 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 | Week 20 | -1.7 Units on scale | Standard Error 0.1 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.019395% CI: [-0.3, 0]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.011495% CI: [-0.4, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: 0.000695% CI: [-0.5, -0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [-0.7, -0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: 0.005895% CI: [-0.5, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.001895% CI: [-0.6, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.000995% CI: [-0.6, -0.2]ANCOVA
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
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 frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | -16.2 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | -13.6 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | -8.7 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | -17.4 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | -17.5 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | -17.4 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | -4.5 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | -15.4 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | -6.8 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | -10.6 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | -12.6 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | -15.5 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | -3.2 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | -14.6 Units on scale | Standard Error 0.5 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.010395% CI: [-2.3, -0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.003195% CI: [-3, -0.6]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: <0.000195% CI: [-4.4, -1.7]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [-5, -2.2]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: <0.000195% CI: [-4, -1.5]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.001295% CI: [-3.3, -0.8]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.004295% CI: [-3.4, -0.7]ANCOVA
Secondary
Change From Baseline in the Photographed Image of Lesions in Selected Participants
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.
Time frame: Baseline to Week 24
Population: The data was not collected as planned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unknown | Change From Baseline in the Photographed Image of Lesions in Selected Participants | Yes | — Units on scale |
| Unknown | Change From Baseline in the Photographed Image of Lesions in Selected Participants | No | — Units on scale |
Secondary
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at 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.
Time frame: Week 12
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Overall appearance of your skin | 3.2 Units on scale | Standard Deviation 0.9 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Flaking skin | 3.3 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin tightness | 3.4 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin pain | 3.8 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Comfort level with your appearance | 3.2 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Anxiety | 3.2 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Depression | 3.5 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Would like to continue with my current treatment | 3.7 Units on scale | Standard Deviation 0.6 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Joint pain | 3.1 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin redness | 3.2 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin bleeding | 3.8 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Burning sensation in the skin | 3.8 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Fatigue | 3.0 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | How others respond to your appearance | 3.5 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | How your skin affects social, leisure activities | 3.1 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Satisfaction with psoriasis treatment in general | 3.3 Units on scale | Standard Deviation 0.8 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Flaking skin | 2.7 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Overall appearance of your skin | 2.6 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | How others respond to your appearance | 2.9 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin redness | 2.5 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin tightness | 3.0 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Burning sensation in the skin | 3.0 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Fatigue | 2.9 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin bleeding | 3.2 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Comfort level with your appearance | 2.7 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | How your skin affects social, leisure activities | 2.7 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Joint pain | 2.9 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Satisfaction with psoriasis treatment in general | 2.9 Units on scale | Standard Deviation 1 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Anxiety | 3.1 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Would like to continue with my current treatment | 3.5 Units on scale | Standard Deviation 0.9 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Skin pain | 3.1 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 | Depression | 3.2 Units on scale | Standard Deviation 1.4 |
Secondary
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24
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.
Time frame: Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | How others respond to your appearance | 3.4 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin tightness | 3.5 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Satisfaction with psoriasis treatment in general | 3.2 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin pain | 3.7 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Joint pain | 3.3 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin bleeding | 3.8 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Would like to continue with my current treatment | 3.5 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Anxiety | 3.4 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Comfort level with your appearance | 3.2 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Depression | 3.3 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Flaking skin | 3.4 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Fatigue | 3.1 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Burning sensation in the skin | 3.7 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | How your skin affects social, leisure activities | 3.4 Units on scale | Standard Deviation 1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin redness | 3.3 Units on scale | Standard Deviation 1.1 |
| ETN 50 mg BW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Overall appearance of your skin | 3.2 Units on scale | Standard Deviation 1 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Would like to continue with my current treatment | 3.4 Units on scale | Standard Deviation 1 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin tightness | 3.2 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin bleeding | 3.3 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin pain | 3.3 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Fatigue | 3.0 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Satisfaction with psoriasis treatment in general | 3.1 Units on scale | Standard Deviation 1 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Overall appearance of your skin | 2.8 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Flaking skin | 3.0 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Skin redness | 2.9 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Burning sensation in the skin | 3.3 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Joint pain | 3.1 Units on scale | Standard Deviation 1.5 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Comfort level with your appearance | 2.9 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Anxiety | 3.2 Units on scale | Standard Deviation 1.5 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | Depression | 3.4 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | How others respond to your appearance | 3.2 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 | How your skin affects social, leisure activities | 3.2 Units on scale | Standard Deviation 1.4 |
Secondary
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
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).
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 0.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 0.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 14.3 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 3.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 7.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 14.3 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 8.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 0.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 4.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 1.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 2.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 7.3 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
Comparison: Comparison between treatment groups at Week 295% CI: [-0.74, 0.74]
Comparison: Comparison between treatment groups at Week 4p-value: 195% CI: [-2.9, 1.44]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.498395% CI: [-4.21, 1.29]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.495795% CI: [-3.23, 6.37]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.311595% CI: [-3.24, 9.52]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.077395% CI: [-1.13, 15.1]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.18395% CI: [-2.82, 13.87]Fisher Exact
Secondary
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
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).
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 9.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 38.3 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 71.4 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 92.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 88.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 92.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 93.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 81.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 5.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 20.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 51.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 78.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 82.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 67.9 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.360595% CI: [-3.88, 10.16]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.001395% CI: [6.5, 29.32]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.001195% CI: [7.51, 31.7]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [9.77, 30.4]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.00195% CI: [5.39, 23.37]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.008795% CI: [2.35, 19.16]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.006895% CI: [2.77, 20.15]Fisher Exact
Secondary
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
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).
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 1.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 35.3 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 62.4 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 78.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 78.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 6.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 72.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 59.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 4.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 21.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 51.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 37.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 58.4 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.243595% CI: [-1.31, 4.32]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.592995% CI: [-4.4, 7.67]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.015695% CI: [2.02, 24.86]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [12.89, 37.47]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.000395% CI: [9.82, 33.85]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.000695% CI: [8.23, 31.38]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.001595% CI: [6.8, 29.88]Fisher Exact
Secondary
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
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).
Time frame: Baseline to week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 29.3 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 9.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 42.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 45.1 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 0.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 49.6 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 24 | 32.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 12 | 10.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 16 | 25.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 4 | 0.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 8 | 5.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 | Week 20 | 29.2 Percentage of participants |
Comparison: Comparison between treatment groups at Week 295% CI: [-0.74, 0.74]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 195% CI: [-2.77, 2.81]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.261195% CI: [-3.2, 11.07]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.000295% CI: [8.3, 28.45]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.003195% CI: [5.43, 29.19]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.008195% CI: [3.8, 28.04]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.006495% CI: [4.46, 29.1]Fisher Exact
Secondary
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 24 | 69.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 12 | 54.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 16 | 60.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 2 | 0.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 4 | 12.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 8 | 33.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 20 | 65.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 8 | 18.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 4 | 6.6 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 12 | 32.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 20 | 50.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 24 | 50.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 16 | 47.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 | Week 2 | 2.2 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.622395% CI: [-5.07, 2.16]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.195% CI: [-1.56, 13.98]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.003795% CI: [4.53, 26.65]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.000495% CI: [9.75, 34.33]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.028595% CI: [0.94, 25.97]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.013995% CI: [2.67, 27.43]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.001295% CI: [7.38, 31.74]Fisher Exact
Secondary
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 16 | 12.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 20 | 19.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 24 | 21.1 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 4 | 0.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 8 | 1.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 12 | 9.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 24 | 12.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 12 | 2.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 4 | 0.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 16 | 9.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 20 | 10.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 8 | 1.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 | Week 2 | 0.0 Percentage of participants |
Comparison: Comparison between treatment groups at Week 295% CI: [-0.74, 0.74]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 195% CI: [-2.9, 1.44]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 195% CI: [-3.58, 3.67]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.040195% CI: [-0.26, 12.47]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.441595% CI: [-4.95, 11.54]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.061795% CI: [-0.67, 17.87]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.07295% CI: [-0.96, 18.24]Fisher Exact
Secondary
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24
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 frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 20 | 88.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 8 | 72.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 24 | 89.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 4 | 46.6 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 12 | 88.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 16 | 88.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 2 | 27.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 12 | 69.3 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 2 | 22.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 4 | 38.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 8 | 59.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 20 | 78.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 16 | 75.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 | Week 24 | 78.1 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.395695% CI: [-6.01, 16.03]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.175495% CI: [-3.82, 21.14]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.020795% CI: [1.9, 25.72]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [9.23, 29.53]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.004495% CI: [3.79, 23.29]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.022395% CI: [1.11, 20.13]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.013395% CI: [1.96, 20.78]Fisher Exact
Secondary
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24
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.
Time frame: From Week 12 to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 12 | 89.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 16 | 85.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 20 | 86.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 24 | 85.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 24 | 83.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 12 | 89.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 20 | 82.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 | Week 16 | 81.0 Percentage of participants |
Comparison: Comparison between treatment groups at Week 12p-value: 195% CI: [-7.7, 8.55]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.421395% CI: [-5.75, 13.63]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.403995% CI: [-5.38, 13.35]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.616895% CI: [-6.87, 11.88]Fisher Exact
Secondary
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ETN 50 mg BW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 75 | 85 Days |
| ETN 50 mg BW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 50 | 57 Days |
| ETN 50 mg BW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 90 | 141 Days |
| ETN 50 mg BW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 100 | NA Days |
| ETN 50 mg QW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 75 | 113 Days |
| ETN 50 mg QW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 100 | NA Days |
| ETN 50 mg QW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 90 | 171 Days |
| ETN 50 mg QW/QW | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | PASI 50 | 57 Days |
Comparison: Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.p-value: <0.0001Log Rank
Comparison: Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.p-value: <0.0001Log Rank
Comparison: Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.p-value: 0.0053Log Rank
Comparison: Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.p-value: 0.0432Log Rank
Secondary
Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks
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).
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ETN 50 mg BW/QW | Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | PGA Clear / Almost Clear (0, 1) | 85 Days |
| ETN 50 mg BW/QW | Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | PGA Clear / Almost Clear / Mild (0, 1, 2) | 53 Days |
| ETN 50 mg QW/QW | Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | PGA Clear / Almost Clear (0, 1) | 114 Days |
| ETN 50 mg QW/QW | Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks | PGA Clear / Almost Clear / Mild (0, 1, 2) | 57 Days |
Comparison: Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.p-value: 0.0003Log Rank
Comparison: Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.p-value: 0.0022Log Rank
Other Pre-specified
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24
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).
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 4 | -7.1 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 12 | -10.2 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 20 | -10.5 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 16 | -10.7 Units on scale | Standard Error 0.4 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 8 | -9.0 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 24 | -10.5 Units on scale | Standard Error 0.5 |
| ETN 50 mg BW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 2 | -4.6 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 24 | -9.2 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 4 | -5.9 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 20 | -9.0 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 2 | -4.3 Units on scale | Standard Error 0.4 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 8 | -7.0 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 12 | -8.1 Units on scale | Standard Error 0.5 |
| ETN 50 mg QW/QW | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | Week 16 | -8.8 Units on scale | Standard Error 0.4 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.574895% CI: [-1.5, 0.8]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.047195% CI: [-2.4, 0]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: 0.002595% CI: [-3.3, -0.7]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: 0.000995% CI: [-3.5, -0.9]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: 0.001595% CI: [-3.1, -0.7]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.019795% CI: [-2.7, -0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.050695% CI: [-2.6, 0]ANCOVA
Other Pre-specified
Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12
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.
Time frame: Baseline, Week 12
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12 | -3.7 Units on scale | Standard Error 1 |
| ETN 50 mg QW/QW | Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12 | -3.5 Units on scale | Standard Error 0.9 |
p-value: 0.86295% CI: [-2.8, 2.3]ANCOVA
Other Pre-specified
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 2 | -0.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 8 | -2.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 12 | -2.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 16 | -2.2 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 20 | -2.3 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 24 | -2.2 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 4 | -1.5 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 16 | -1.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 4 | -1.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 24 | -2.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 8 | -1.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 20 | -1.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 12 | -1.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 | Week 2 | -0.7 Units on scale | Standard Error 0.1 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.639695% CI: [-0.3, 0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.007495% CI: [-0.7, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: 0.000795% CI: [-0.9, -0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [-1.1, -0.5]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: 0.00495% CI: [-0.8, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.000495% CI: [-0.9, -0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.179995% CI: [-0.5, -0.1]ANCOVA
Other Pre-specified
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 4 | -0.7 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 16 | -0.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 8 | -0.7 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 20 | -0.9 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 12 | -0.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 24 | -0.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 2 | -0.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 24 | -0.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 2 | -0.5 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 8 | -0.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 4 | -0.5 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 12 | -0.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 16 | -0.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 | Week 20 | -0.6 Units on scale | Standard Error 0.1 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.775795% CI: [-0.2, 0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.211295% CI: [-0.4, 0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: 0.546795% CI: [-0.3, 0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: 0.368495% CI: [-0.4, 0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: -0.204695% CI: [-0.4, 0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.064995% CI: [-0.5, 0]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.868395% CI: [-0.3, 0.2]ANCOVA
Other Pre-specified
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 24 | -2.5 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 4 | -1.8 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 20 | -2.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 8 | -2.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 2 | -1.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 12 | -2.5 Units on scale | Standard Error 0.1 |
| ETN 50 mg BW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 16 | -2.6 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 12 | -1.9 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 16 | -2.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 20 | -2.1 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 24 | -2.2 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 2 | -1.0 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 4 | -1.4 Units on scale | Standard Error 0.1 |
| ETN 50 mg QW/QW | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 | Week 8 | -1.7 Units on scale | Standard Error 0.1 |
Comparison: Comparison between treatment groups at Week 2p-value: 0.889895% CI: [-0.3, 0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 4p-value: 0.00995% CI: [-0.7, -0.1]ANCOVA
Comparison: Comparison between treatment groups at Week 8p-value: 0.002895% CI: [-0.7, -0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 12p-value: 0.000195% CI: [-0.9, -0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 16p-value: <0.000195% CI: [-0.9, -0.3]ANCOVA
Comparison: Comparison between treatment groups at Week 20p-value: 0.001695% CI: [-0.8, -0.2]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.060295% CI: [-0.6, 0]ANCOVA
Other Pre-specified
Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index
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.
Time frame: Baseline, Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | Week 24 | 0.21 Units on scale | Standard Error 0.02 |
| ETN 50 mg BW/QW | Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | Week 12 | 0.21 Units on scale | Standard Error 0.02 |
| ETN 50 mg QW/QW | Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | Week 12 | 0.17 Units on scale | Standard Error 0.02 |
| ETN 50 mg QW/QW | Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | Week 24 | 0.15 Units on scale | Standard Error 0.02 |
Comparison: Comparison between treatment groups at Week 12p-value: 0.043595% CI: [0, 0.09]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.027595% CI: [0.01, 0.1]ANCOVA
Other Pre-specified
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
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.
Time frame: Baseline, Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 24 | -1.9 Units on scale | Standard Error 0.3 |
| ETN 50 mg BW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 12 | -1.6 Units on scale | Standard Error 0.3 |
| ETN 50 mg QW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 12 | -1.6 Units on scale | Standard Error 0.3 |
| ETN 50 mg QW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 24 | -1.8 Units on scale | Standard Error 0.3 |
Comparison: Comparison between treatment groups at Week 12p-value: 0.947395% CI: [-0.7, 0.7]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.821795% CI: [-0.8, 0.6]ANCOVA
Other Pre-specified
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score
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.
Time frame: Baseline, Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 12 | -1.9 Units on scale | Standard Error 0.3 |
| ETN 50 mg BW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 24 | -2.2 Units on scale | Standard Error 0.3 |
| ETN 50 mg QW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 12 | -1.3 Units on scale | Standard Error 0.3 |
| ETN 50 mg QW/QW | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 24 | -1.7 Units on scale | Standard Error 0.3 |
Comparison: Comparison between treatment groups at Week 12p-value: 0.053995% CI: [-1.4, 0]ANCOVA
Comparison: Comparison between treatment groups at Week 24p-value: 0.149495% CI: [-1.3, 0.2]ANCOVA
Other Pre-specified
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores
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.
Time frame: Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | Week 12 | 41.8 Units on scale | Standard Deviation 8.1 |
| ETN 50 mg BW/QW | Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | Week 24 | 41.9 Units on scale | Standard Deviation 8.3 |
| ETN 50 mg QW/QW | Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | Week 12 | 40.1 Units on scale | Standard Deviation 8.6 |
| ETN 50 mg QW/QW | Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | Week 24 | 40.8 Units on scale | Standard Deviation 9.1 |
Other Pre-specified
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12
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.
Time frame: Week 12
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Disturbance | 30.1 Units on scale | Standard Deviation 21.3 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Somnolence | 27.3 Units on scale | Standard Deviation 19.8 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Problem Index I | 29.3 Units on scale | Standard Deviation 17.8 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Short of Breath or Headache | 13.6 Units on scale | Standard Deviation 20.8 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Quantity | 7.2 Units on scale | Standard Deviation 1.4 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Adequacy | 59.8 Units on scale | Standard Deviation 26.4 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Problem Index II | 30.1 Units on scale | Standard Deviation 17.5 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Snoring | 35.7 Units on scale | Standard Deviation 27.8 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Problem Index II | 30.8 Units on scale | Standard Deviation 17.7 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Disturbance | 28.4 Units on scale | Standard Deviation 21.1 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Quantity | 6.9 Units on scale | Standard Deviation 1.2 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Problem Index I | 30.4 Units on scale | Standard Deviation 17.8 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Snoring | 45.3 Units on scale | Standard Deviation 30.3 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Somnolence | 28.8 Units on scale | Standard Deviation 20.3 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Short of Breath or Headache | 15.3 Units on scale | Standard Deviation 21.2 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 | Sleep Adequacy | 55.6 Units on scale | Standard Deviation 24.4 |
Other Pre-specified
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24
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.
Time frame: Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Disturbance | 26.7 Units on scale | Standard Deviation 19.8 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Short of Breath or Headache | 11.9 Units on scale | Standard Deviation 17.3 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Quantity | 7.2 Units on scale | Standard Deviation 1.5 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Snoring | 38.2 Units on scale | Standard Deviation 31.1 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Somnolence | 27.0 Units on scale | Standard Deviation 18.4 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Adequacy | 59.8 Units on scale | Standard Deviation 25.4 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Problem Index I | 27.3 Units on scale | Standard Deviation 15.9 |
| ETN 50 mg BW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Problem Index II | 28.2 Units on scale | Standard Deviation 15.7 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Snoring | 44.0 Units on scale | Standard Deviation 31.3 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Somnolence | 28.1 Units on scale | Standard Deviation 20.3 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Adequacy | 60.9 Units on scale | Standard Deviation 26.7 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Disturbance | 26.6 Units on scale | Standard Deviation 21.1 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Short of Breath or Headache | 13.9 Units on scale | Standard Deviation 19.7 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Quantity | 7.0 Units on scale | Standard Deviation 1.3 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Problem Index II | 28.4 Units on scale | Standard Deviation 17.5 |
| ETN 50 mg QW/QW | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 | Sleep Problem Index I | 27.7 Units on scale | Standard Deviation 17.7 |
Other Pre-specified
Mean Number of Doctor Visits
As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.
Time frame: Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Number of Doctor Visits | Week 12 | 2.2 Visits | Standard Deviation 1.25 |
| ETN 50 mg BW/QW | Mean Number of Doctor Visits | Week 24 | 2.4 Visits | Standard Deviation 1.99 |
| ETN 50 mg QW/QW | Mean Number of Doctor Visits | Week 12 | 3.3 Visits | Standard Deviation 3.89 |
| ETN 50 mg QW/QW | Mean Number of Doctor Visits | Week 24 | 1.9 Visits | Standard Deviation 1.28 |
Comparison: Comparison of treatment groups at Week 12p-value: 0.0807ANCOVA
Comparison: Comparison of treatment groups at Week 24p-value: 0.1454ANCOVA
Other Pre-specified
Mean Number of Emergency Room Days
As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.
Time frame: Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Mean Number of Emergency Room Days | Week 12 | 1.0 Days | — |
| ETN 50 mg BW/QW | Mean Number of Emergency Room Days | Week 24 | 1.0 Days | Standard Deviation 0 |
| ETN 50 mg QW/QW | Mean Number of Emergency Room Days | Week 12 | 3.6 Days | Standard Deviation 5.81 |
| ETN 50 mg QW/QW | Mean Number of Emergency Room Days | Week 24 | 1.0 Days | — |
Other Pre-specified
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 8 | 83.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 20 | 91.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 12 | 91.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 2 | 66.9 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 16 | 91.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 24 | 88.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 4 | 77.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 24 | 81.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 12 | 83.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 2 | 54.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 8 | 72.3 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 16 | 84.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 20 | 83.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 | Week 4 | 68.6 Percentage of participants |
Comparison: Comparison between treatment groups at Week 20p-value: 0.06395% CI: [-0.68, 16.26]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.090795% CI: [-1.53, 16.93]Fisher Exact
Comparison: Comparison between treatment groups at Week 2p-value: 0.046195% CI: [-0.24, 24.44]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.131495% CI: [-2.44, 20.1]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.028995% CI: [0.65, 21.74]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.043395% CI: [-0.04, 17.07]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.090295% CI: [-1.32, 15.43]Fisher Exact
Other Pre-specified
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 8 | 68.4 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 24 | 86.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 2 | 33.1 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 4 | 53.4 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 20 | 87.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 12 | 87.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 16 | 85.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 24 | 75.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 4 | 38.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 8 | 54.0 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 16 | 75.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 12 | 65.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 20 | 75.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 | Week 2 | 27.4 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.352595% CI: [-6.05, 17.4]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.020295% CI: [2.19, 27.2]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.017895% CI: [2.17, 26.64]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: <0.000195% CI: [11.02, 32.03]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.032595% CI: [0.43, 20.64]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.012995% CI: [2.1, 21.97]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.020995% CI: [1.26, 21.3]Fisher Exact
Other Pre-specified
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 24 | 85.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 8 | 81.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 16 | 85.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 20 | 85.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 2 | 47.4 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 12 | 85.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 4 | 68.4 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 12 | 70.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 4 | 59.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 2 | 44.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 8 | 69.3 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 16 | 73.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 20 | 75.9 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 24 | 74.5 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.625595% CI: [-9.39, 15.9]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.129295% CI: [-2.85, 21.45]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.025195% CI: [0.94, 22.78]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.005595% CI: [3.68, 24.64]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.015995% CI: [1.78, 22.2]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.067295% CI: [-1.08, 19.18]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.035195% CI: [0.27, 20.75]Fisher Exact
Other Pre-specified
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
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.
Time frame: Baseline to Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 12 | 92.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 24 | 87.2 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 8 | 92.5 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 4 | 88.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 20 | 91.7 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 16 | 91.0 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 2 | 82.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 16 | 86.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 2 | 76.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 4 | 82.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 12 | 82.5 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 20 | 86.1 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 24 | 83.2 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | Week 8 | 82.5 Percentage of participants |
Comparison: Comparison between treatment groups at Week 2p-value: 0.228395% CI: [-4.11, 16.58]Fisher Exact
Comparison: Comparison between treatment groups at Week 4p-value: 0.232695% CI: [-3.68, 14.66]Fisher Exact
Comparison: Comparison between treatment groups at Week 8p-value: 0.016595% CI: [1.47, 18.52]Fisher Exact
Comparison: Comparison between treatment groups at Week 12p-value: 0.016595% CI: [1.47, 18.52]Fisher Exact
Comparison: Comparison between treatment groups at Week 16p-value: 0.253695% CI: [-3.46, 13.15]Fisher Exact
Comparison: Comparison between treatment groups at Week 20p-value: 0.176195% CI: [-2.59, 13.78]Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 0.394395% CI: [-5.18, 13.2]Fisher Exact
Other Pre-specified
Percentage of Participants With Doctor Visits
As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.
Time frame: Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants With Doctor Visits | Week 12 | 29.8 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants With Doctor Visits | Week 24 | 31.7 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants With Doctor Visits | Week 12 | 36.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants With Doctor Visits | Week 24 | 31.7 Percentage of participants |
Comparison: Comparison between treatment groups at Week 12p-value: 0.2443Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 1Fisher Exact
Other Pre-specified
Percentage of Participants With Emergency Room Visits
As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.
Time frame: Week 12 and Week 24
Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN 50 mg BW/QW | Percentage of Participants With Emergency Room Visits | Week 24 | 1.6 Percentage of participants |
| ETN 50 mg BW/QW | Percentage of Participants With Emergency Room Visits | Week 12 | 0.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants With Emergency Room Visits | Week 24 | 0.8 Percentage of participants |
| ETN 50 mg QW/QW | Percentage of Participants With Emergency Room Visits | Week 12 | 3.7 Percentage of participants |
Comparison: Comparison between treatment groups at Week 12p-value: 0.2139Fisher Exact
Comparison: Comparison between treatment groups at Week 24p-value: 1Fisher Exact
Other Pre-specified
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12
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 \[completely prevented from working\]).
Time frame: Week 12
Population: mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Activity Impairment (n=131, 135) | 16.87 Percentage of indicated parameter | Standard Deviation 21.49 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Impairment While Working (n=66, 78) | 10.25 Percentage of indicated parameter | Standard Deviation 14.41 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Work Time Missed (n=66, 73) | 4.35 Percentage of indicated parameter | Standard Deviation 16.86 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Overall Work Impairment (n=64, 71)) | 14.30 Percentage of indicated parameter | Standard Deviation 21.49 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Work Time Missed (n=66, 73) | 4.85 Percentage of indicated parameter | Standard Deviation 19.11 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Activity Impairment (n=131, 135) | 21.78 Percentage of indicated parameter | Standard Deviation 25.65 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Impairment While Working (n=66, 78) | 13.19 Percentage of indicated parameter | Standard Deviation 20.43 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | Percent Overall Work Impairment (n=64, 71)) | 16.88 Percentage of indicated parameter | Standard Deviation 25.24 |
Other Pre-specified
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24
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 \[completely prevented from working\]).
Time frame: Week 24
Population: mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Impairment While Working (n=72, 81) | 8.00 Percentage of indicated parameter | Standard Deviation 11.34 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Overall Work Impairment (n=70, 76) | 12.78 Percentage of indicated parameter | Standard Deviation 20.27 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Work Time Missed (n=72, 78) | 5.03 Percentage of indicated parameter | Standard Deviation 17.57 |
| ETN 50 mg BW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Activity Impairment (n=131, 135)) | 13.28 Percentage of indicated parameter | Standard Deviation 18.99 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Activity Impairment (n=131, 135)) | 18.85 Percentage of indicated parameter | Standard Deviation 24.58 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Impairment While Working (n=72, 81) | 13.43 Percentage of indicated parameter | Standard Deviation 19.57 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Work Time Missed (n=72, 78) | 3.10 Percentage of indicated parameter | Standard Deviation 13.91 |
| ETN 50 mg QW/QW | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | Percent Overall Work Impairment (n=70, 76) | 15.96 Percentage of indicated parameter | Standard Deviation 23.05 |