Nail Psoriasis, Plaque Psoriasis
Conditions
Keywords
Nail Psoriasis, Plaque Psoriasis
Brief summary
The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.
Detailed description
This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.
Interventions
DRUGetanercept
Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks. Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Active, stable plaque psoriasis defined by the following criteria: * Body surface area (BSA) ≥ 10 % at screening and baseline * Or, PASI \>10 at screening and baseline * Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline * Or, DLQI \> 10 at baseline * Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI \> 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator. * Failure of at least one systemic psoriasis therapy for nail psoriasis * Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
Exclusion criteria
* Evidence of Skin conditions other than psoriasis * Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation * Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail | Baseline, Week 24 | Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12, Week 24 | Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis. |
| Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12, Week 24 | Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis. |
| Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12, Week 24 | NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail). |
| Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12, Week 24 | NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail). |
| Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | Baseline, Week 24 | 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). |
| Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 , Week 24 | 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). |
| Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 , Week 24 | 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 Overall Nail Psoriasis Severity Index (NAPSI) Score | Baseline, Week 24 | NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail). |
| Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear | Baseline, Week 24 or Early Termination | Physician Global Assessment (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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint). |
| Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better | Baseline, Week 24 or Early Termination | Physician Global Assessment (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. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration). |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) | Baseline, Week 24 | Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL. |
| Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | Baseline, Week 24 | Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease). |
| Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | Baseline, Week 24 | Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease). |
| Change From Baseline in Physician Fingernail Grading Assessment Total Score | Baseline, Week 24 | Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30. |
| Change From Baseline in Physician Global Assessment (PGA) of Psoriasis | Baseline, Week 24 | Physician Global Assessment (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. |
Participant flow
Pre-assignment details
Eighty-five participants were screened for the study; 13 participants were screening failures, and 72 participants were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept: Twice, Then Once Weekly Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 | 36 |
| Etanercept: Once Weekly Etanercept 50 mg SC once weekly for the complete 24 week treatment period | 33 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Other | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Etanercept: Twice, Then Once Weekly | Etanercept: Once Weekly | Total |
|---|---|---|---|
| Age, Customized | 46.28 years STANDARD_DEVIATION 13.51 | 45.36 years STANDARD_DEVIATION 9.19 | 45.84 years STANDARD_DEVIATION 11.57 |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 38 | 12 / 34 |
| serious Total, serious adverse events | 2 / 38 | 0 / 34 |
Outcome results
Primary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time frame: Baseline, Week 24
Population: Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail | -4.32 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail | -4.36 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time frame: Baseline, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score | -22.64 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score | -22.63 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time frame: Baseline, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | -48.89 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | -41.69 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time frame: Baseline, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | -44.66 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) | -41.03 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in Physician Fingernail Grading Assessment Total Score
Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.
Time frame: Baseline, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Physician Fingernail Grading Assessment Total Score | -11.47 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in Physician Fingernail Grading Assessment Total Score | -12.21 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis
Physician Global Assessment (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, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis | -1.65 unts on a scale |
| Etanercept: Once Weekly | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis | -1.84 unts on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.
Time frame: Baseline, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in the Dermatology Life Quality Index (DLQI) | -8.60 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in the Dermatology Life Quality Index (DLQI) | -8.74 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
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, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -14.81 units on a scale |
| Etanercept: Once Weekly | Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score | -14.11 units on a scale |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
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 12 , Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 | 90.91 percent of participants |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 24 | 85.71 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 | 87.10 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 24 | 84.38 percent of participants |
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Secondary
Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
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 12 , Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 | 51.52 percent of participants |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 24 | 77.14 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 12 | 58.06 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 | Week 24 | 62.50 percent of participants |
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Secondary
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear
Physician Global Assessment (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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time frame: Baseline, Week 24 or Early Termination
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear | 68.57 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear | 75.00 percent of participants |
p-value: <0.001GEE model
p-value: <0.001GEE model
Secondary
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better
Physician Global Assessment (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. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).
Time frame: Baseline, Week 24 or Early Termination
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better | 82.86 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better | 87.50 percent of participants |
p-value: <0.001GEE model
p-value: <0.001GEE model
Secondary
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time frame: Week 12, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12 | 54.55 percent of participants |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 24 | 68.57 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12 | 48.39 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 24 | 81.25 percent of participants |
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Secondary
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.
Time frame: Week 12, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12 | 60.61 percent of participants |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 24 | 82.86 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12 | 51.61 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 24 | 81.25 percent of participants |
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 12p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Secondary
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time frame: Week 12, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12 | 9.09 units on a scale |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 24 | 62.86 units on a scale |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 12 | 19.35 units on a scale |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 | Week 24 | 62.50 units on a scale |
Comparison: Week 12p-value: 0.069GEE model
Comparison: Week 12p-value: 0.006GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model
Secondary
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time frame: Week 12, Week 24
Population: mITT, N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12 | 18.18 percent of participants |
| Etanercept: Twice, Then Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 24 | 57.14 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 12 | 19.35 percent of participants |
| Etanercept: Once Weekly | Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 | Week 24 | 68.75 percent of participants |
Comparison: Week 12p-value: 0.007GEE model
Comparison: Week 12p-value: 0.006GEE model
Comparison: Week 24p-value: <0.001GEE model
Comparison: Week 24p-value: <0.001GEE model