Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis (NCT NCT00936065)

NCT ID: NCT00936065

Last Updated: 2012-04-09

Results Overview

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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Week 24

Results posted on

2012-04-09

Participant Flow

Participant milestones

Participant milestones
Measure
Etanercept
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Study
STARTED
21
20
19
Overall Study
Received Treatment
21
20
18
Overall Study
Study Assessments Performed
21
19
18
Overall Study
COMPLETED
17
16
12
Overall Study
NOT COMPLETED
4
4
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Etanercept
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Study
Adverse Event
1
0
1
Overall Study
Lack of Efficacy
1
0
1
Overall Study
Lost to Follow-up
1
0
0
Overall Study
Protocol Violation
1
2
1
Overall Study
Withdrawal by Subject
0
2
4

Baseline Characteristics

Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Total
n=58 Participants
Total of all reporting groups
Age Continuous
38.57 years
STANDARD_DEVIATION 9.53 • n=5 Participants
35.5 years
STANDARD_DEVIATION 8.75 • n=7 Participants
42.39 years
STANDARD_DEVIATION 11.95 • n=5 Participants
38.78 years
STANDARD_DEVIATION 10.31 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
10 Participants
n=4 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
17 Participants
n=7 Participants
15 Participants
n=5 Participants
48 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)

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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
52.38 percentage of participants
Interval 29.78 to 74.29
57.89 percentage of participants
Interval 33.5 to 79.75
22.22 percentage of participants
Interval 6.41 to 47.64

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 18, and 24

Population: mITT; LOCF

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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 2
4.76 percentage of participants
Interval 0.12 to 23.82
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 8
71.43 percentage of participants
Interval 47.82 to 88.72
57.89 percentage of participants
Interval 33.5 to 79.75
27.78 percentage of participants
Interval 9.69 to 53.48
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 12
76.19 percentage of participants
Interval 52.83 to 91.78
78.95 percentage of participants
Interval 54.43 to 93.95
22.22 percentage of participants
Interval 6.41 to 47.64
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 18
76.19 percentage of participants
Interval 52.83 to 91.78
84.21 percentage of participants
Interval 60.42 to 96.62
38.89 percentage of participants
Interval 17.3 to 64.25
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 24
71.43 percentage of participants
Interval 47.82 to 88.72
84.21 percentage of participants
Interval 60.42 to 96.62
44.44 percentage of participants
Interval 21.53 to 69.24
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 4
47.62 percentage of participants
Interval 25.71 to 70.22
15.79 percentage of participants
Interval 3.38 to 39.58
11.11 percentage of participants
Interval 1.38 to 34.71

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

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 = PGA score of 0 (no evidence).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Baseline
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 4
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 18
9.52 Percentage of participants
Interval 1.17 to 30.38
5.26 Percentage of participants
Interval 0.13 to 26.03
5.56 Percentage of participants
Interval 0.14 to 27.29
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 24
9.52 Percentage of participants
Interval 1.17 to 30.38
10.53 Percentage of participants
Interval 1.3 to 33.14
5.56 Percentage of participants
Interval 0.14 to 27.29
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 2
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 8
4.76 Percentage of participants
Interval 0.12 to 23.82
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 12
9.52 Percentage of participants
Interval 1.17 to 30.38
0 Percentage of participants
Interval 0.0 to 0.0
0 Percentage of participants
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

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).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Baseline
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 2
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
5.56 percentage of participants
Interval 0.14 to 27.29
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 4
19.05 percentage of participants
Interval 5.45 to 41.91
5.26 percentage of participants
Interval 0.13 to 26.03
11.11 percentage of participants
Interval 1.38 to 34.71
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 8
28.57 percentage of participants
Interval 11.28 to 52.18
21.05 percentage of participants
Interval 6.05 to 45.57
5.56 percentage of participants
Interval 0.14 to 27.29
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 12
42.86 percentage of participants
Interval 21.82 to 65.98
21.05 percentage of participants
Interval 6.05 to 45.57
5.56 percentage of participants
Interval 0.14 to 27.29
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 18
33.33 percentage of participants
Interval 14.59 to 56.97
31.58 percentage of participants
Interval 12.58 to 56.55
16.67 percentage of participants
Interval 3.58 to 41.42
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 24
52.38 percentage of participants
Interval 29.78 to 74.29
52.63 percentage of participants
Interval 28.86 to 75.55
16.67 percentage of participants
Interval 3.58 to 41.42

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

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 or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Baseline
14.29 percentage of participants
Interval 3.05 to 36.34
5.26 percentage of participants
Interval 0.13 to 26.03
16.67 percentage of participants
Interval 3.58 to 41.42
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 2
33.33 percentage of participants
Interval 14.59 to 56.97
26.32 percentage of participants
Interval 9.15 to 51.2
11.11 percentage of participants
Interval 1.38 to 34.71
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 4
42.86 percentage of participants
Interval 21.82 to 65.98
47.37 percentage of participants
Interval 24.45 to 74.14
16.67 percentage of participants
Interval 3.58 to 41.42
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 8
61.90 percentage of participants
Interval 38.44 to 81.89
42.11 percentage of participants
Interval 20.25 to 66.5
27.78 percentage of participants
Interval 9.69 to 53.48
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 12
76.19 percentage of participants
Interval 52.83 to 91.78
78.95 percentage of participants
Interval 54.43 to 93.95
33.33 percentage of participants
Interval 13.34 to 59.01
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 18
80.95 percentage of participants
Interval 58.09 to 94.55
84.21 percentage of participants
Interval 60.42 to 96.62
38.89 percentage of participants
Interval 17.3 to 64.25
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 24
76.19 percentage of participants
Interval 52.83 to 91.78
84.21 percentage of participants
Interval 60.42 to 96.62
33.33 percentage of participants
Interval 13.34 to 59.01

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT

PASI 50 defined as a 50% or greater improvement in PASI score from Baseline

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Time to Achieve a PASI 50 Score
56 days
Interval 28.0 to 56.0
56 days
Interval 54.0 to 84.0
126 days
Interval 56.0 to
Not Available (NA): The number of events to observe the upper limit of 95% Confidence Interval (CI) did not occur during the specified period.

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT

PASI 75 defined as a 75% or greater improvement in PASI score from Baseline

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Time to Achieve a PASI 75 Score
126 days
Interval 56.0 to 146.0
146 days
Interval 124.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
NA days
Interval 127.0 to
The number of events to observe the median time to PASI 75 did not occur during the specified period.

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT

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 or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
57 days
Interval 19.0 to 84.0
57 days
Interval 14.0 to 84.0
169 days
Interval 56.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT

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).

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
167 days
Interval 55.0 to 172.0
165 days
Interval 59.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
NA days
Interval 87.0 to
The number of events to observe the median time to achieve PGA of Clear or Almost Clear did not occur during the specified period.

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18, and 24

Population: mITT; LOCF

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 = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in the PGA of Psoriasis
Change at Week 8
-1.34 units on a scale
Standard Deviation 1.07
-1.09 units on a scale
Standard Deviation 0.86
-0.43 units on a scale
Standard Deviation 0.91
Change From Baseline in the PGA of Psoriasis
Change at Week 12
-1.62 units on a scale
Standard Deviation 1.33
-1.42 units on a scale
Standard Deviation 0.69
-0.48 units on a scale
Standard Deviation 0.98
Change From Baseline in the PGA of Psoriasis
Baseline
3.40 units on a scale
Standard Deviation 0.82
3.38 units on a scale
Standard Deviation 0.59
3.50 units on a scale
Standard Deviation 0.92
Change From Baseline in the PGA of Psoriasis
Change at Week 2
-0.51 units on a scale
Standard Deviation 0.71
-0.35 units on a scale
Standard Deviation 0.58
0.02 units on a scale
Standard Deviation 0.56
Change From Baseline in the PGA of Psoriasis
Change at Week 4
-1.00 units on a scale
Standard Deviation 1.03
-0.84 units on a scale
Standard Deviation 0.60
-0.26 units on a scale
Standard Deviation 0.74
Change From Baseline in the PGA of Psoriasis
Change at Week 18
-1.58 units on a scale
Standard Deviation 1.33
-1.68 units on a scale
Standard Deviation 1.00
-0.69 units on a scale
Standard Deviation 1.35
Change From Baseline in the PGA of Psoriasis
Change at Week 24
-1.67 units on a scale
Standard Deviation 1.47
-1.86 units on a scale
Standard Deviation 1.06
-0.71 units on a scale
Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

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

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in the PASI Score
Change at Week 24
-12.16 units on a scale
Standard Deviation 12.15
-13.92 units on a scale
Standard Deviation 5.75
-9.62 units on a scale
Standard Deviation 10.10
Change From Baseline in the PASI Score
Baseline
20.83 units on a scale
Standard Deviation 14.02
19.75 units on a scale
Standard Deviation 9.85
26.31 units on a scale
Standard Deviation 13.63
Change From Baseline in the PASI Score
Change at Week 2
-5.38 units on a scale
Standard Deviation 7.13
-3.27 units on a scale
Standard Deviation 1.88
-3.17 units on a scale
Standard Deviation 5.60
Change From Baseline in the PASI Score
Change at Week 4
-9.98 units on a scale
Standard Deviation 10.64
-6.45 units on a scale
Standard Deviation 3.19
-4.06 units on a scale
Standard Deviation 5.68
Change From Baseline in the PASI Score
Change at Week 8
-11.11 units on a scale
Standard Deviation 10.89
-9.96 units on a scale
Standard Deviation 3.73
-6.84 units on a scale
Standard Deviation 9.57
Change From Baseline in the PASI Score
Change at Week 12
-11.97 units on a scale
Standard Deviation 11.63
-11.39 units on a scale
Standard Deviation 4.72
-6.71 units on a scale
Standard Deviation 6.81
Change From Baseline in the PASI Score
Change at Week 18
-12.13 units on a scale
Standard Deviation 11.67
-13.54 units on a scale
Standard Deviation 6.80
-8.77 units on a scale
Standard Deviation 8.54

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Baseline
32.98 percentage of BSA
Standard Deviation 20.21
32.50 percentage of BSA
Standard Deviation 24.15
39.75 percentage of BSA
Standard Deviation 22.96
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
-2.64 percentage of BSA
Standard Deviation 6.69
-1.55 percentage of BSA
Standard Deviation 5.07
-0.36 percentage of BSA
Standard Deviation 5.54
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
-12.67 percentage of BSA
Standard Deviation 13.17
-7.97 percentage of BSA
Standard Deviation 9.27
-5.14 percentage of BSA
Standard Deviation 16.96
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
-15.43 percentage of BSA
Standard Deviation 14.90
-10.29 percentage of BSA
Standard Deviation 9.19
-5.08 percentage of BSA
Standard Deviation 11.89
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
-16.57 percentage of BSA
Standard Deviation 14.70
-14.76 percentage of BSA
Standard Deviation 11.61
-9.25 percentage of BSA
Standard Deviation 16.72
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
-7.36 percentage of BSA
Standard Deviation 10.89
-4.50 percentage of BSA
Standard Deviation 6.48
-0.75 percentage of BSA
Standard Deviation 7.66
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
-17.52 percentage of BSA
Standard Deviation 14.91
-16.87 percentage of BSA
Standard Deviation 10.79
-10.30 percentage of BSA
Standard Deviation 18.86

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data

Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Baseline
0.67 units on a scale
Standard Deviation 1.43
0.56 units on a scale
Standard Deviation 1.15
0.94 units on a scale
Standard Deviation 1.73
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 4
0.29 units on a scale
Standard Deviation 1.19
-0.06 units on a scale
Standard Deviation 0.42
-0.72 units on a scale
Standard Deviation 1.81
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 8
0.19 units on a scale
Standard Deviation 0.81
-0.22 units on a scale
Standard Deviation 0.88
-0.56 units on a scale
Standard Deviation 1.72
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 12
0.00 units on a scale
Standard Deviation 0.63
-0.28 units on a scale
Standard Deviation 0.96
-0.44 units on a scale
Standard Deviation 2.36
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 18
-0.05 units on a scale
Standard Deviation 0.67
-0.28 units on a scale
Standard Deviation 1.02
-0.44 units on a scale
Standard Deviation 1.85
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 2
0.00 units on a scale
Standard Deviation 0.71
0.00 units on a scale
Standard Deviation 0.49
-0.44 units on a scale
Standard Deviation 1.10
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 24
0.29 units on a scale
Standard Deviation 1.06
-0.39 units on a scale
Standard Deviation 0.85
-0.61 units on a scale
Standard Deviation 2.03

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 ,18 and 24

Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data

Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 12
-2.67 units on a scale
Standard Deviation 1.56
-2.28 units on a scale
Standard Deviation 1.53
-1.61 units on a scale
Standard Deviation 1.72
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 18
-2.57 units on a scale
Standard Deviation 1.99
-2.11 units on a scale
Standard Deviation 1.78
-1.83 units on a scale
Standard Deviation 1.76
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Baseline
3.90 units on a scale
Standard Deviation 1.09
3.94 units on a scale
Standard Deviation 1.06
4.72 units on a scale
Standard Deviation 0.67
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 2
-0.90 units on a scale
Standard Deviation 1.58
-0.33 units on a scale
Standard Deviation 1.24
-0.72 units on a scale
Standard Deviation 1.02
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 4
-1.86 units on a scale
Standard Deviation 1.28
-0.94 units on a scale
Standard Deviation 1.26
-0.83 units on a scale
Standard Deviation 1.04
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 8
-2.29 units on a scale
Standard Deviation 1.79
-1.89 units on a scale
Standard Deviation 1.49
-1.67 units on a scale
Standard Deviation 1.71
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 24
-1.81 units on a scale
Standard Deviation 2.20
-2.39 units on a scale
Standard Deviation 1.54
-1.72 units on a scale
Standard Deviation 1.93

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12 ,18 and 24

Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data

Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in SGA of Itching at Each Visit
Change at Week 4
-1.52 units on a scale
Standard Deviation 1.33
-0.61 units on a scale
Standard Deviation 1.65
-0.39 units on a scale
Standard Deviation 2.03
Change From Baseline in SGA of Itching at Each Visit
Change at Week 8
-1.86 units on a scale
Standard Deviation 2.06
-1.06 units on a scale
Standard Deviation 1.76
-1.28 units on a scale
Standard Deviation 1.71
Change From Baseline in SGA of Itching at Each Visit
Change at Week 12
-2.10 units on a scale
Standard Deviation 2.07
-1.44 units on a scale
Standard Deviation 2.09
-1.22 units on a scale
Standard Deviation 1.73
Change From Baseline in SGA of Itching at Each Visit
Baseline
3.33 units on a scale
Standard Deviation 1.35
3.11 units on a scale
Standard Deviation 1.81
3.72 units on a scale
Standard Deviation 1.45
Change From Baseline in SGA of Itching at Each Visit
Change at Week 2
-0.67 units on a scale
Standard Deviation 1.59
0.28 units on a scale
Standard Deviation 1.74
-0.39 units on a scale
Standard Deviation 1.29
Change From Baseline in SGA of Itching at Each Visit
Change at Week 18
-1.81 units on a scale
Standard Deviation 2.06
-1.83 units on a scale
Standard Deviation 1.76
-1.17 units on a scale
Standard Deviation 1.62
Change From Baseline in SGA of Itching at Each Visit
Change at Week 24
-1.19 units on a scale
Standard Deviation 2.23
-1.83 units on a scale
Standard Deviation 2.04
-1.06 units on a scale
Standard Deviation 1.89

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.81 Units on a scale
Standard Deviation 1.25
0.79 Units on a scale
Standard Deviation 1.40
0.28 Units on a scale
Standard Deviation 1.41
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.57 Units on a scale
Standard Deviation 1.16
0.95 Units on a scale
Standard Deviation 1.31
0.50 Units on a scale
Standard Deviation 1.38
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
2.10 Units on a scale
Standard Deviation 1.58
1.58 Units on a scale
Standard Deviation 1.71
0.78 Units on a scale
Standard Deviation 1.40
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
2.10 Units on a scale
Standard Deviation 1.58
1.74 Units on a scale
Standard Deviation 1.76
0.56 Units on a scale
Standard Deviation 1.38
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
2.24 Units on a scale
Standard Deviation 1.87
1.95 Units on a scale
Standard Deviation 1.54
1.06 Units on a scale
Standard Deviation 1.66
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.76 Units on a scale
Standard Deviation 1.67
2.05 Units on a scale
Standard Deviation 1.18
1.11 Units on a scale
Standard Deviation 1.84
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
0.67 Units on a scale
Standard Deviation 0.80
0.74 Units on a scale
Standard Deviation 0.99
0.44 Units on a scale
Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
1.00 Units on a scale
Standard Deviation 1.30
0.84 Units on a scale
Standard Deviation 1.21
0.56 Units on a scale
Standard Deviation 0.78
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
1.14 Units on a scale
Standard Deviation 1.53
1.21 Units on a scale
Standard Deviation 1.51
0.39 Units on a scale
Standard Deviation 1.50
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.57 Units on a scale
Standard Deviation 1.36
0.68 Units on a scale
Standard Deviation 1.42
0.94 Units on a scale
Standard Deviation 1.66
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
2.38 Units on a scale
Standard Deviation 1.83
1.53 Units on a scale
Standard Deviation 1.95
1.11 Units on a scale
Standard Deviation 1.78
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
2.67 Units on a scale
Standard Deviation 1.88
1.63 Units on a scale
Standard Deviation 1.46
0.83 Units on a scale
Standard Deviation 1.76
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
2.33 Units on a scale
Standard Deviation 2.01
1.89 Units on a scale
Standard Deviation 1.41
1.28 Units on a scale
Standard Deviation 1.84
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.90 Units on a scale
Standard Deviation 2.17
2.21 Units on a scale
Standard Deviation 1.18
1.17 Units on a scale
Standard Deviation 1.86

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
2.00 Units on a scale
Standard Deviation 2.02
2.21 Units on a scale
Standard Deviation 1.23
1.00 Units on a scale
Standard Deviation 1.41
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
0.90 Units on a scale
Standard Deviation 1.18
0.63 Units on a scale
Standard Deviation 1.01
0.72 Units on a scale
Standard Deviation 0.89
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.86 Units on a scale
Standard Deviation 1.20
1.32 Units on a scale
Standard Deviation 1.34
0.17 Units on a scale
Standard Deviation 1.20
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.95 Units on a scale
Standard Deviation 1.24
1.16 Units on a scale
Standard Deviation 1.17
0.44 Units on a scale
Standard Deviation 1.04
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
2.05 Units on a scale
Standard Deviation 2.04
1.58 Units on a scale
Standard Deviation 1.71
0.83 Units on a scale
Standard Deviation 1.34
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
2.19 Units on a scale
Standard Deviation 1.97
1.68 Units on a scale
Standard Deviation 1.67
0.61 Units on a scale
Standard Deviation 1.38
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
2.05 Units on a scale
Standard Deviation 2.20
2.16 Units on a scale
Standard Deviation 1.21
1.22 Units on a scale
Standard Deviation 1.52

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
2.43 Units on a scale
Standard Deviation 2.34
1.32 Units on a scale
Standard Deviation 1.29
0.83 Units on a scale
Standard Deviation 1.76
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
2.67 Units on a scale
Standard Deviation 2.18
1.74 Units on a scale
Standard Deviation 1.48
0.61 Units on a scale
Standard Deviation 2.20
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.90 Units on a scale
Standard Deviation 2.47
2.00 Units on a scale
Standard Deviation 1.05
0.56 Units on a scale
Standard Deviation 1.62
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
1.33 Units on a scale
Standard Deviation 1.28
1.11 Units on a scale
Standard Deviation 1.05
1.83 Units on a scale
Standard Deviation 1.76
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
1.48 Units on a scale
Standard Deviation 1.50
0.42 Units on a scale
Standard Deviation 1.61
-0.11 Units on a scale
Standard Deviation 1.57
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
2.19 Units on a scale
Standard Deviation 1.72
0.79 Units on a scale
Standard Deviation 1.13
0.44 Units on a scale
Standard Deviation 1.79
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
2.48 Units on a scale
Standard Deviation 2.16
2.05 Units on a scale
Standard Deviation 1.18
0.78 Units on a scale
Standard Deviation 1.77

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.57 Units on a scale
Standard Deviation 1.60
0.68 Units on a scale
Standard Deviation 1.53
0.28 Units on a scale
Standard Deviation 1.74
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.00 Units on a scale
Standard Deviation 1.95
0.74 Units on a scale
Standard Deviation 1.45
0.56 Units on a scale
Standard Deviation 2.09
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.43 Units on a scale
Standard Deviation 1.99
1.05 Units on a scale
Standard Deviation 1.22
0.44 Units on a scale
Standard Deviation 1.82
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.81 Units on a scale
Standard Deviation 1.86
2.84 Units on a scale
Standard Deviation 1.64
2.89 Units on a scale
Standard Deviation 2.14
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.00 Units on a scale
Standard Deviation 2.32
0.84 Units on a scale
Standard Deviation 1.64
0.61 Units on a scale
Standard Deviation 2.20
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.43 Units on a scale
Standard Deviation 2.23
0.74 Units on a scale
Standard Deviation 1.28
0.78 Units on a scale
Standard Deviation 2.41
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.38 Units on a scale
Standard Deviation 2.25
1.16 Units on a scale
Standard Deviation 1.92
0.67 Units on a scale
Standard Deviation 2.09

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.81 Units on a scale
Standard Deviation 1.69
2.37 Units on a scale
Standard Deviation 1.86
2.28 Units on a scale
Standard Deviation 2.05
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.57 Units on a scale
Standard Deviation 1.57
0.37 Units on a scale
Standard Deviation 1.30
-0.44 Units on a scale
Standard Deviation 1.65
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.76 Units on a scale
Standard Deviation 1.81
0.89 Units on a scale
Standard Deviation 1.49
-0.06 Units on a scale
Standard Deviation 2.53
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.24 Units on a scale
Standard Deviation 1.92
1.58 Units on a scale
Standard Deviation 1.71
0.61 Units on a scale
Standard Deviation 2.33
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
0.86 Units on a scale
Standard Deviation 1.98
1.37 Units on a scale
Standard Deviation 1.54
0.78 Units on a scale
Standard Deviation 1.90
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.14 Units on a scale
Standard Deviation 1.96
1.16 Units on a scale
Standard Deviation 1.86
0.56 Units on a scale
Standard Deviation 2.28
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
0.67 Units on a scale
Standard Deviation 2.35
1.05 Units on a scale
Standard Deviation 1.72
0.44 Units on a scale
Standard Deviation 2.06

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.95 Units on a scale
Standard Deviation 1.63
2.21 Units on a scale
Standard Deviation 1.78
2.72 Units on a scale
Standard Deviation 2.11
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.90 Units on a scale
Standard Deviation 1.76
1.00 Units on a scale
Standard Deviation 1.41
0.50 Units on a scale
Standard Deviation 2.26
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.24 Units on a scale
Standard Deviation 2.00
1.32 Units on a scale
Standard Deviation 1.45
0.89 Units on a scale
Standard Deviation 2.30
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.29 Units on a scale
Standard Deviation 2.05
1.32 Units on a scale
Standard Deviation 1.45
0.78 Units on a scale
Standard Deviation 2.73
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.10 Units on a scale
Standard Deviation 2.02
1.63 Units on a scale
Standard Deviation 1.71
1.00 Units on a scale
Standard Deviation 2.45
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.48 Units on a scale
Standard Deviation 1.75
0.89 Units on a scale
Standard Deviation 1.59
0.28 Units on a scale
Standard Deviation 1.96
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
0.62 Units on a scale
Standard Deviation 2.27
1.37 Units on a scale
Standard Deviation 1.89
0.67 Units on a scale
Standard Deviation 2.14

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
4.43 Units on a scale
Standard Deviation 1.16
3.79 Units on a scale
Standard Deviation 1.40
4.17 Units on a scale
Standard Deviation 1.58
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
-0.52 Units on a scale
Standard Deviation 1.21
0.05 Units on a scale
Standard Deviation 0.91
0.22 Units on a scale
Standard Deviation 1.77
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
-0.33 Units on a scale
Standard Deviation 1.20
0.21 Units on a scale
Standard Deviation 1.03
0.33 Units on a scale
Standard Deviation 1.53
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
-0.33 Units on a scale
Standard Deviation 1.11
-0.05 Units on a scale
Standard Deviation 1.18
0.17 Units on a scale
Standard Deviation 0.99
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
-0.29 Units on a scale
Standard Deviation 1.15
0.21 Units on a scale
Standard Deviation 1.18
0.00 Units on a scale
Standard Deviation 2.35
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
-0.14 Units on a scale
Standard Deviation 0.85
0.37 Units on a scale
Standard Deviation 1.38
-0.28 Units on a scale
Standard Deviation 1.60
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
-0.57 Units on a scale
Standard Deviation 1.47
0.05 Units on a scale
Standard Deviation 1.22
0.17 Units on a scale
Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
1.14 Units on a scale
Standard Deviation 1.56
0.79 Units on a scale
Standard Deviation 0.79
0.83 Units on a scale
Standard Deviation 1.10
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.43 Units on a scale
Standard Deviation 1.21
0.63 Units on a scale
Standard Deviation 1.46
-0.11 Units on a scale
Standard Deviation 1.23
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.57 Units on a scale
Standard Deviation 2.29
2.21 Units on a scale
Standard Deviation 1.13
0.78 Units on a scale
Standard Deviation 1.44
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.90 Units on a scale
Standard Deviation 1.64
1.05 Units on a scale
Standard Deviation 1.43
-0.11 Units on a scale
Standard Deviation 1.23
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.48 Units on a scale
Standard Deviation 1.91
1.58 Units on a scale
Standard Deviation 1.61
0.44 Units on a scale
Standard Deviation 1.29
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.52 Units on a scale
Standard Deviation 2.18
1.89 Units on a scale
Standard Deviation 1.41
0.17 Units on a scale
Standard Deviation 1.34
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.90 Units on a scale
Standard Deviation 2.51
1.68 Units on a scale
Standard Deviation 1.29
0.72 Units on a scale
Standard Deviation 1.45

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.29 Units on a scale
Standard Deviation 1.87
1.89 Units on a scale
Standard Deviation 1.73
2.22 Units on a scale
Standard Deviation 1.80
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
1.05 Units on a scale
Standard Deviation 1.66
0.63 Units on a scale
Standard Deviation 1.89
-0.39 Units on a scale
Standard Deviation 1.54
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.24 Units on a scale
Standard Deviation 1.55
1.21 Units on a scale
Standard Deviation 1.84
-0.61 Units on a scale
Standard Deviation 1.61
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.57 Units on a scale
Standard Deviation 1.91
1.47 Units on a scale
Standard Deviation 1.95
0.33 Units on a scale
Standard Deviation 2.06
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.52 Units on a scale
Standard Deviation 2.14
1.68 Units on a scale
Standard Deviation 1.73
0.22 Units on a scale
Standard Deviation 2.60
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.57 Units on a scale
Standard Deviation 2.01
1.53 Units on a scale
Standard Deviation 1.87
0.56 Units on a scale
Standard Deviation 2.15
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.24 Units on a scale
Standard Deviation 1.95
1.58 Units on a scale
Standard Deviation 1.68
0.67 Units on a scale
Standard Deviation 2.25

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.43 Units on a scale
Standard Deviation 1.91
1.95 Units on a scale
Standard Deviation 1.72
2.33 Units on a scale
Standard Deviation 1.85
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.95 Units on a scale
Standard Deviation 1.32
1.11 Units on a scale
Standard Deviation 1.63
-0.11 Units on a scale
Standard Deviation 1.18
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.33 Units on a scale
Standard Deviation 1.59
1.26 Units on a scale
Standard Deviation 1.97
-0.22 Units on a scale
Standard Deviation 1.59
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.19 Units on a scale
Standard Deviation 2.02
1.68 Units on a scale
Standard Deviation 1.70
0.67 Units on a scale
Standard Deviation 1.50
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.38 Units on a scale
Standard Deviation 1.83
1.47 Units on a scale
Standard Deviation 2.20
0.28 Units on a scale
Standard Deviation 1.41
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.71 Units on a scale
Standard Deviation 2.05
1.58 Units on a scale
Standard Deviation 1.64
0.17 Units on a scale
Standard Deviation 2.04
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.57 Units on a scale
Standard Deviation 2.09
1.47 Units on a scale
Standard Deviation 1.81
0.61 Units on a scale
Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.95 Units on a scale
Standard Deviation 1.75
1.74 Units on a scale
Standard Deviation 1.52
2.78 Units on a scale
Standard Deviation 1.73
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.48 Units on a scale
Standard Deviation 1.86
0.89 Units on a scale
Standard Deviation 1.56
-0.72 Units on a scale
Standard Deviation 1.99
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
0.29 Units on a scale
Standard Deviation 1.82
0.95 Units on a scale
Standard Deviation 2.07
-0.33 Units on a scale
Standard Deviation 2.35
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
0.48 Units on a scale
Standard Deviation 1.89
1.37 Units on a scale
Standard Deviation 1.61
-0.61 Units on a scale
Standard Deviation 2.06
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.29 Units on a scale
Standard Deviation 1.76
0.68 Units on a scale
Standard Deviation 1.80
-0.56 Units on a scale
Standard Deviation 2.01
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
0.48 Units on a scale
Standard Deviation 1.89
0.95 Units on a scale
Standard Deviation 1.72
-0.89 Units on a scale
Standard Deviation 2.42
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
0.24 Units on a scale
Standard Deviation 2.02
1.21 Units on a scale
Standard Deviation 2.20
-0.67 Units on a scale
Standard Deviation 2.06

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
2.29 Units on a scale
Standard Deviation 1.85
1.53 Units on a scale
Standard Deviation 1.02
1.83 Units on a scale
Standard Deviation 1.62
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.00 Units on a scale
Standard Deviation 1.67
0.53 Units on a scale
Standard Deviation 1.50
-0.39 Units on a scale
Standard Deviation 1.58
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.00 Units on a scale
Standard Deviation 1.73
1.11 Units on a scale
Standard Deviation 1.56
-0.22 Units on a scale
Standard Deviation 1.77
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
0.95 Units on a scale
Standard Deviation 1.91
1.53 Units on a scale
Standard Deviation 1.43
-0.33 Units on a scale
Standard Deviation 1.88
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
0.95 Units on a scale
Standard Deviation 1.86
1.42 Units on a scale
Standard Deviation 1.57
0.11 Units on a scale
Standard Deviation 2.14
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
0.95 Units on a scale
Standard Deviation 1.99
1.63 Units on a scale
Standard Deviation 1.46
-0.11 Units on a scale
Standard Deviation 2.05
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.05 Units on a scale
Standard Deviation 1.69
0.74 Units on a scale
Standard Deviation 1.05
-0.33 Units on a scale
Standard Deviation 1.91

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.57 Units on a scale
Standard Deviation 1.36
0.74 Units on a scale
Standard Deviation 1.41
-0.06 Units on a scale
Standard Deviation 1.43
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.10 Units on a scale
Standard Deviation 1.64
0.89 Units on a scale
Standard Deviation 0.99
0.22 Units on a scale
Standard Deviation 1.73
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.76 Units on a scale
Standard Deviation 1.79
1.58 Units on a scale
Standard Deviation 1.61
0.28 Units on a scale
Standard Deviation 1.45
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.90 Units on a scale
Standard Deviation 1.84
1.68 Units on a scale
Standard Deviation 1.70
0.50 Units on a scale
Standard Deviation 1.82
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
0.95 Units on a scale
Standard Deviation 1.02
0.89 Units on a scale
Standard Deviation 0.94
1.39 Units on a scale
Standard Deviation 1.50
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
2.10 Units on a scale
Standard Deviation 2.02
1.89 Units on a scale
Standard Deviation 1.52
-0.06 Units on a scale
Standard Deviation 1.70
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.57 Units on a scale
Standard Deviation 2.09
1.95 Units on a scale
Standard Deviation 1.61
0.28 Units on a scale
Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
1.19 Units on a scale
Standard Deviation 1.12
1.37 Units on a scale
Standard Deviation 1.21
1.41 Units on a scale
Standard Deviation 1.18
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
1.24 Units on a scale
Standard Deviation 1.18
1.00 Units on a scale
Standard Deviation 1.60
0.18 Units on a scale
Standard Deviation 1.55
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
1.67 Units on a scale
Standard Deviation 1.20
1.00 Units on a scale
Standard Deviation 1.37
0.12 Units on a scale
Standard Deviation 1.58
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
1.67 Units on a scale
Standard Deviation 1.32
1.37 Units on a scale
Standard Deviation 1.83
0.53 Units on a scale
Standard Deviation 1.55
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
1.90 Units on a scale
Standard Deviation 1.51
1.53 Units on a scale
Standard Deviation 1.74
0.35 Units on a scale
Standard Deviation 1.87
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
1.86 Units on a scale
Standard Deviation 1.56
1.74 Units on a scale
Standard Deviation 1.52
0.82 Units on a scale
Standard Deviation 1.78
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
1.38 Units on a scale
Standard Deviation 1.47
1.68 Units on a scale
Standard Deviation 1.60
0.76 Units on a scale
Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
3.10 Units on a scale
Standard Deviation 1.22
3.42 Units on a scale
Standard Deviation 1.02
2.82 Units on a scale
Standard Deviation 1.42
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
0.48 Units on a scale
Standard Deviation 1.17
0.11 Units on a scale
Standard Deviation 1.20
0.00 Units on a scale
Standard Deviation 1.80
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
0.48 Units on a scale
Standard Deviation 1.50
0.21 Units on a scale
Standard Deviation 1.13
-0.29 Units on a scale
Standard Deviation 2.08
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
0.67 Units on a scale
Standard Deviation 1.24
0.05 Units on a scale
Standard Deviation 1.18
-0.12 Units on a scale
Standard Deviation 1.93
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
0.52 Units on a scale
Standard Deviation 1.54
0.26 Units on a scale
Standard Deviation 1.05
0.06 Units on a scale
Standard Deviation 1.98
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
0.48 Units on a scale
Standard Deviation 1.50
0.16 Units on a scale
Standard Deviation 1.21
-0.29 Units on a scale
Standard Deviation 2.14
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
0.14 Units on a scale
Standard Deviation 1.53
0.11 Units on a scale
Standard Deviation 1.10
-0.18 Units on a scale
Standard Deviation 1.88

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
9.52 Percentage of participants
Interval 1.17 to 30.38
15.79 Percentage of participants
Interval 3.38 to 39.58
22.22 Percentage of participants
Interval 6.41 to 47.64
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 4
42.86 Percentage of participants
Interval 21.82 to 65.98
52.63 Percentage of participants
Interval 28.86 to 75.55
33.33 Percentage of participants
Interval 13.34 to 59.01
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 8
57.14 Percentage of participants
Interval 34.02 to 78.18
57.89 Percentage of participants
Interval 33.5 to 79.75
33.33 Percentage of participants
Interval 13.34 to 59.01
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 12
71.43 Percentage of participants
Interval 47.82 to 88.72
57.89 Percentage of participants
Interval 33.5 to 79.75
33.33 Percentage of participants
Interval 13.34 to 59.01
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 18
71.43 Percentage of participants
Interval 47.82 to 88.72
63.16 Percentage of participants
Interval 38.36 to 83.71
38.89 Percentage of participants
Interval 17.3 to 64.25
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 24
57.14 Percentage of participants
Interval 34.02 to 78.18
73.68 Percentage of participants
Interval 48.8 to 90.85
38.89 Percentage of participants
Interval 17.3 to 64.25
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 2
14.29 Percentage of participants
Interval 3.05 to 36.34
42.11 Percentage of participants
Interval 20.25 to 66.5
27.78 Percentage of participants
Interval 9.69 to 53.48

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24

Population: mITT; LOCF

Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported.

Outcome measures

Outcome measures
Measure
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 2
80.95 percentage of participants
Interval 58.09 to 94.55
78.95 percentage of participants
Interval 54.43 to 93.95
50.00 percentage of participants
Interval 26.02 to 73.98
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 4
85.71 percentage of participants
Interval 63.66 to 96.95
94.74 percentage of participants
Interval 73.97 to 99.87
55.56 percentage of participants
Interval 30.76 to 78.47
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 8
90.48 percentage of participants
Interval 69.62 to 98.83
89.47 percentage of participants
Interval 66.86 to 98.7
66.67 percentage of participants
Interval 40.99 to 86.66
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 12
95.24 percentage of participants
Interval 76.18 to 99.88
73.68 percentage of participants
Interval 48.8 to 90.85
61.11 percentage of participants
Interval 35.75 to 82.7
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 18
90.48 percentage of participants
Interval 69.62 to 98.83
94.74 percentage of participants
Interval 73.97 to 99.87
61.11 percentage of participants
Interval 35.75 to 82.7
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 24
80.95 percentage of participants
Interval 58.09 to 94.55
94.74 percentage of participants
Interval 73.97 to 99.87
55.56 percentage of participants
Interval 30.76 to 78.47
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
38.10 percentage of participants
Interval 18.11 to 61.56
42.11 percentage of participants
Interval 20.25 to 66.5
33.33 percentage of participants
Interval 14.21 to 61.67

Adverse Events

Etanercept

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Etanercept and Acitretin

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Acitretin

Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Etanercept
n=21 participants at risk
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=20 participants at risk
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 participants at risk
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure
Etanercept
n=21 participants at risk
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin
n=20 participants at risk
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin
n=18 participants at risk
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Skin and subcutaneous tissue disorders
Pruritus
14.3%
3/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
20.0%
4/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Acne
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Ingrowing nail
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Pain of skin
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Skin reaction
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Skin tightness
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Lip dry
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
15.0%
3/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Cheilitis
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Chapped lips
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Nausea
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
Alanine aminotransferase increased
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
Blood bilirubin increased
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
Aspartate aminotransferase increased
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
Hepatic enzyme increased
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
Liver function test abnormal
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations
White blood cell count increased
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Arthralgia
9.5%
2/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Back pain
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Dizziness
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Burning sensation
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Headache
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Neuropathy peripheral
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders
Asthenia
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders
Condition aggravated
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders
Fatigue
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders
Injection site reaction
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders
Oedema peripheral
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Nasal dryness
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Vascular disorders
Hypertension
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Vascular disorders
Flushing
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Depression
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Insomnia
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders
Cholelithiasis
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Paronychia
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER