Trial Outcomes & Findings for Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab (NCT NCT01543204)
NCT ID: NCT01543204
Last Updated: 2017-12-29
Results Overview
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
TERMINATED
PHASE4
64 participants
Week 12
2017-12-29
Participant Flow
This study was conducted at 48 centers in the United States (US) and Canada. Participants were enrolled from 01 February 2012 until 04 November 2014.
Participant milestones
| Measure |
Etanercept 50 mg
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Etanercept 50 mg
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Requirement for Alternative Therapy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
Baseline characteristics by cohort
| Measure |
Etanercept 50 mg
n=64 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
57 participants
n=5 Participants
|
|
Psoriasis Area Severity Index (PASI)
|
16.81 units on a scale
STANDARD_DEVIATION 6.86 • n=5 Participants
|
|
Percent of Body Surface Area (BSA) Involved in Psoriasis
|
20.90 percentage of BSA
STANDARD_DEVIATION 16.00 • n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
0 = Clear
|
0 participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
1 = Almost clear
|
0 participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
2 = Mild
|
0 participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
3 = Moderate
|
50 participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
4 = Severe
|
14 participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
5 = Very severe
|
0 participants
n=5 Participants
|
|
Dermatology Life Quality Index (DLQI)
|
12.7 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Patient Assessment of Flaking
|
7.0 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Patient Assessment of Itch
|
6.5 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Patient Assessment of Pain
|
5.0 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Very dissatisfied
|
24 participants
n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Dissatisfied
|
14 participants
n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Neither satisfied nor dissatisfied
|
20 participants
n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Satisfied
|
2 participants
n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Very satisfied
|
2 participants
n=5 Participants
|
|
Patient Assessment of Treatment Satisfaction
Missing
|
2 participants
n=5 Participants
|
|
Anti-adalimumab Antibody Status at Screening
Negative
|
21 participants
n=5 Participants
|
|
Anti-adalimumab Antibody Status at Screening
Positive
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12
|
39.7 percentage of participants
Interval 27.6 to 52.8
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: The primary analysis set with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Outcome measures
| Measure |
Etanercept 50 mg
n=40 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=20 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status
|
45.0 percentage of participants
Interval 29.26 to 61.51
|
35.0 percentage of participants
Interval 15.39 to 59.22
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Week 4
|
4.8 percentage of participants
Interval 1.0 to 13.3
|
—
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Week 8
|
23.8 percentage of participants
Interval 14.0 to 36.2
|
—
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Week 16
|
39.7 percentage of participants
Interval 27.6 to 52.8
|
—
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Week 20
|
42.9 percentage of participants
Interval 30.5 to 56.0
|
—
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Week 24
|
38.1 percentage of participants
Interval 26.1 to 51.2
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 20 and 24Population: Primary analysis set participants with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Week 16 (n = 37, 19)
|
37.8 percentage of participants
Interval 22.46 to 55.24
|
42.1 percentage of participants
Interval 20.25 to 66.5
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Week 20 (n = 38, 19)
|
44.7 percentage of participants
Interval 28.62 to 61.7
|
47.4 percentage of participants
Interval 24.45 to 71.14
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Week 24 (n = 37, 18)
|
40.5 percentage of participants
Interval 24.75 to 57.9
|
38.9 percentage of participants
Interval 17.3 to 64.25
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Week 4 (n = 42, 21)
|
4.8 percentage of participants
Interval 0.58 to 16.16
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Week 8 (n = 39, 21)
|
17.9 percentage of participants
Interval 7.54 to 33.53
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 4
|
52.4 percentage of participants
Interval 39.4 to 65.1
|
—
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 8
|
71.4 percentage of participants
Interval 58.7 to 82.1
|
—
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 12
|
84.1 percentage of participants
Interval 72.7 to 92.1
|
—
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 16
|
76.2 percentage of participants
Interval 63.8 to 86.0
|
—
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 20
|
76.2 percentage of participants
Interval 63.8 to 86.0
|
—
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 24
|
73.0 percentage of participants
Interval 60.3 to 83.4
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 4 (n = 42, 21)
|
45.2 percentage of participants
Interval 29.85 to 61.33
|
66.7 percentage of participants
Interval 43.03 to 85.41
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 8 (n = 39, 21)
|
61.5 percentage of participants
Interval 44.62 to 76.64
|
90.5 percentage of participants
Interval 69.62 to 98.83
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 12 (n = 40, 20)
|
85.0 percentage of participants
Interval 70.16 to 94.29
|
95.0 percentage of participants
Interval 75.13 to 99.87
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 16 (n = 37, 19)
|
81.1 percentage of participants
Interval 64.84 to 92.04
|
73.7 percentage of participants
Interval 48.8 to 90.85
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 20 (n = 38, 19)
|
81.6 percentage of participants
Interval 65.67 to 92.26
|
78.9 percentage of participants
Interval 54.43 to 93.95
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Week 24 (n = 37, 18)
|
78.4 percentage of participants
Interval 61.79 to 90.17
|
77.8 percentage of participants
Interval 52.36 to 93.59
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 4
|
2.5 units on a scale
Standard Deviation 0.7 • Interval 39.4 to 65.1
|
—
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 8
|
2.1 units on a scale
Standard Deviation 0.8 • Interval 58.7 to 82.1
|
—
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 12
|
1.7 units on a scale
Standard Deviation 0.9 • Interval 72.7 to 92.1
|
—
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 16
|
1.8 units on a scale
Standard Deviation 1.0 • Interval 63.8 to 86.0
|
—
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 20
|
1.7 units on a scale
Standard Deviation 1.0 • Interval 63.8 to 86.0
|
—
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 24
|
1.8 units on a scale
Standard Deviation 1.0 • Interval 60.3 to 83.4
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 4 (n = 42, 21)
|
2.57 units on a scale
Standard Deviation 0.11 • Interval 39.4 to 65.1
|
2.29 units on a scale
Standard Deviation 0.12
|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 8 (n = 39, 21)
|
2.23 units on a scale
Standard Deviation 0.14 • Interval 58.7 to 82.1
|
1.71 units on a scale
Standard Deviation 0.14
|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 12 (n = 40, 20)
|
1.68 units on a scale
Standard Deviation 0.14 • Interval 72.7 to 92.1
|
1.55 units on a scale
Standard Deviation 0.18
|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 16 (n = 37, 19)
|
1.73 units on a scale
Standard Deviation 0.14 • Interval 63.8 to 86.0
|
1.74 units on a scale
Standard Deviation 0.23
|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 20 (n = 38, 19)
|
1.63 units on a scale
Standard Deviation 0.15 • Interval 63.8 to 86.0
|
1.63 units on a scale
Standard Deviation 0.22
|
|
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Week 24 (n = 37, 18)
|
1.73 units on a scale
Standard Deviation 0.16 • Interval 60.3 to 83.4
|
1.83 units on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 20
|
81.0 percentage of participants
Interval 69.1 to 89.8
|
—
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 24
|
81.0 percentage of participants
Interval 69.1 to 89.8
|
—
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 4
|
30.2 percentage of participants
Interval 19.2 to 43.0
|
—
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 8
|
61.9 percentage of participants
Interval 48.8 to 73.9
|
—
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 12
|
77.8 percentage of participants
Interval 65.5 to 87.3
|
—
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 16
|
79.4 percentage of participants
Interval 67.3 to 88.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 12 (n = 40, 20)
|
72.5 percentage of participants
Interval 56.11 to 85.4
|
100.0 percentage of participants
Interval 83.16 to 100.0
|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 20 (n = 38, 19)
|
84.2 percentage of participants
Interval 68.75 to 93.98
|
89.5 percentage of participants
Interval 66.86 to 98.7
|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 16 (n = 37, 19)
|
78.4 percentage of participants
Interval 61.79 to 90.17
|
89.5 percentage of participants
Interval 66.86 to 98.7
|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 24 (n = 37, 18)
|
86.5 percentage of participants
Interval 71.23 to 95.46
|
88.9 percentage of participants
Interval 65.29 to 98.62
|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 4 (n = 42, 21)
|
21.4 percentage of participants
Interval 10.3 to 36.81
|
47.6 percentage of participants
Interval 25.71 to 70.22
|
|
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
Week 8 (n = 39, 21)
|
59.0 percentage of participants
Interval 42.1 to 74.43
|
76.2 percentage of participants
Interval 52.83 to 91.78
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 4
|
4.8 percentage of participants
Interval 1.0 to 13.3
|
—
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 8
|
25.4 percentage of participants
Interval 15.3 to 37.9
|
—
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 12
|
46.0 percentage of participants
Interval 33.4 to 59.1
|
—
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 16
|
49.2 percentage of participants
Interval 36.4 to 62.1
|
—
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 20
|
50.8 percentage of participants
Interval 37.9 to 63.6
|
—
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 24
|
47.6 percentage of participants
Interval 34.9 to 60.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 12 (n = 40, 20)
|
47.5 percentage of participants
Interval 31.51 to 63.87
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 16 (n = 37, 19)
|
51.4 percentage of participants
Interval 34.4 to 68.08
|
47.4 percentage of participants
Interval 24.45 to 71.14
|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 20 (n = 38, 19)
|
55.3 percentage of participants
Interval 38.3 to 71.38
|
52.6 percentage of participants
Interval 28.86 to 75.55
|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 24 (n = 37, 18)
|
56.8 percentage of participants
Interval 39.49 to 72.9
|
38.9 percentage of participants
Interval 17.3 to 64.25
|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 4 (n = 42, 21)
|
2.4 percentage of participants
Interval 0.06 to 12.57
|
9.5 percentage of participants
Interval 1.17 to 30.38
|
|
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
Week 8 (n = 39, 21)
|
20.5 percentage of participants
Interval 9.3 to 36.46
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 16
|
25.4 percentage of participants
Interval 15.3 to 37.9
|
—
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 20
|
19.0 percentage of participants
Interval 10.2 to 30.9
|
—
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 24
|
23.8 percentage of participants
Interval 14.0 to 36.2
|
—
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 4
|
0 percentage of participants
Interval 0.0 to 5.7
|
—
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 8
|
3.2 percentage of participants
Interval 0.4 to 11.0
|
—
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 12
|
22.2 percentage of participants
Interval 12.7 to 34.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 4 (n = 42, 21)
|
0 percentage of participants
Interval 0.0 to 8.41
|
0 percentage of participants
Interval 0.0 to 16.11
|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 8 (n = 39, 21)
|
5.1 percentage of participants
Interval 0.63 to 17.32
|
0 percentage of participants
Interval 0.0 to 16.11
|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 12 (n = 40, 20)
|
27.5 percentage of participants
Interval 14.6 to 43.89
|
15.0 percentage of participants
Interval 3.21 to 37.89
|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 16 (n = 37, 19)
|
27.0 percentage of participants
Interval 13.79 to 44.12
|
21.1 percentage of participants
Interval 6.05 to 45.57
|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 20 (n = 38, 19)
|
23.7 percentage of participants
Interval 11.44 to 40.24
|
15.8 percentage of participants
Interval 3.38 to 39.58
|
|
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
Week 24 (n = 37, 18)
|
32.4 percentage of participants
Interval 18.01 to 49.79
|
11.1 percentage of participants
Interval 1.38 to 34.71
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 4
|
65.1 percentage of participants
Interval 52.0 to 76.7
|
—
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 8
|
79.4 percentage of participants
Interval 67.3 to 88.5
|
—
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 12
|
85.7 percentage of participants
Interval 74.6 to 93.3
|
—
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 16
|
79.4 percentage of participants
Interval 67.3 to 88.5
|
—
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 20
|
77.8 percentage of participants
Interval 65.5 to 87.3
|
—
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 24
|
76.2 percentage of participants
Interval 63.8 to 86.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 4 (n = 42, 21)
|
64.3 percentage of participants
Interval 48.03 to 78.45
|
66.7 percentage of participants
Interval 43.03 to 85.41
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 8 (n = 39, 21)
|
74.4 percentage of participants
Interval 57.87 to 86.96
|
90.5 percentage of participants
Interval 69.62 to 98.83
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 12 (n = 40, 20)
|
87.5 percentage of participants
Interval 73.2 to 95.81
|
95.0 percentage of participants
Interval 75.13 to 99.87
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 16 (n = 37, 19)
|
86.5 percentage of participants
Interval 71.23 to 95.46
|
73.7 percentage of participants
Interval 48.8 to 90.85
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 20 (n = 38, 19)
|
84.2 percentage of participants
Interval 68.75 to 93.98
|
78.9 percentage of participants
Interval 54.43 to 93.95
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 24 (n = 37, 18)
|
83.8 percentage of participants
Interval 67.99 to 93.81
|
77.8 percentage of participants
Interval 52.36 to 93.59
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 4
|
9.5 percentage of participants
Interval 3.6 to 19.6
|
—
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 8
|
31.7 percentage of participants
Interval 20.6 to 44.7
|
—
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 12
|
54.0 percentage of participants
Interval 40.9 to 66.6
|
—
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 16
|
52.4 percentage of participants
Interval 39.4 to 65.1
|
—
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 20
|
52.4 percentage of participants
Interval 39.4 to 65.1
|
—
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 24
|
49.2 percentage of participants
Interval 36.4 to 62.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 4 (n = 42, 21)
|
11.9 percentage of participants
Interval 3.98 to 25.63
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 8 (n = 39, 21)
|
30.8 percentage of participants
Interval 17.02 to 47.57
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 12 (n = 40, 20)
|
67.5 percentage of participants
Interval 50.87 to 81.43
|
35.0 percentage of participants
Interval 15.39 to 59.22
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 16 (n = 37, 19)
|
59.5 percentage of participants
Interval 42.1 to 75.25
|
42.1 percentage of participants
Interval 20.25 to 66.5
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 20 (n = 38, 19)
|
60.5 percentage of participants
Interval 43.39 to 75.96
|
47.4 percentage of participants
Interval 24.45 to 71.14
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
Week 24 (n = 37, 18)
|
59.5 percentage of participants
Interval 42.1 to 75.25
|
38.9 percentage of participants
Interval 17.3 to 64.25
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 4
|
36.02 percent change
Standard Deviation 22.09 • Interval 19.2 to 43.0
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 8
|
55.33 percent change
Standard Deviation 25.25 • Interval 48.8 to 73.9
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 12
|
67.97 percent change
Standard Deviation 24.20 • Interval 65.5 to 87.3
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 16
|
67.98 percent change
Standard Deviation 29.83 • Interval 67.3 to 88.5
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 20
|
69.58 percent change
Standard Deviation 26.16 • Interval 69.1 to 89.8
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 24
|
67.25 percent change
Standard Deviation 30.41 • Interval 69.1 to 89.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 4 (n = 42, 21)
|
33.38 percent change
Standard Deviation 3.32 • Interval 39.4 to 65.1
|
42.29 percent change
Standard Deviation 4.98
|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 8 (n = 39, 21)
|
55.90 percent change
Standard Deviation 3.93 • Interval 58.7 to 82.1
|
59.33 percent change
Standard Deviation 5.33
|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 12 (n = 40, 20)
|
69.99 percent change
Standard Deviation 3.49 • Interval 72.7 to 92.1
|
73.71 percent change
Standard Deviation 3.12
|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 16 (n = 37, 19)
|
70.76 percent change
Standard Deviation 3.60 • Interval 63.8 to 86.0
|
67.31 percent change
Standard Deviation 8.78
|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 20 (n = 38, 19)
|
73.47 percent change
Standard Deviation 3.75 • Interval 63.8 to 86.0
|
72.79 percent change
Standard Deviation 5.22
|
|
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
Week 24 (n = 37, 18)
|
73.34 percent change
Standard Deviation 3.57 • Interval 60.3 to 83.4
|
65.71 percent change
Standard Deviation 9.03
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 4
|
19.38 percent change
Standard Deviation 29.43 • Interval 19.2 to 43.0
|
—
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 8
|
37.86 percent change
Standard Deviation 32.50 • Interval 48.8 to 73.9
|
—
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 12
|
53.82 percent change
Standard Deviation 32.66 • Interval 65.5 to 87.3
|
—
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 16
|
60.36 percent change
Standard Deviation 29.48 • Interval 67.3 to 88.5
|
—
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 20
|
60.33 percent change
Standard Deviation 29.79 • Interval 69.1 to 89.8
|
—
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
Week 24
|
58.13 percent change
Standard Deviation 34.40 • Interval 69.1 to 89.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20 and 24Population: Primary analysis set participants with available data
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=43 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
n=21 Participants
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 4 (n = 42, 21)
|
24.41 percent change
Standard Deviation 3.99 • Interval 39.4 to 65.1
|
15.32 percent change
Standard Deviation 7.83
|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 8 (n = 39, 21)
|
40.34 percent change
Standard Deviation 5.32 • Interval 58.7 to 82.1
|
34.36 percent change
Standard Deviation 7.23
|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 12 (n = 40, 20)
|
58.58 percent change
Standard Deviation 4.72 • Interval 72.7 to 92.1
|
50.91 percent change
Standard Deviation 8.00
|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 16 (n = 37, 19)
|
61.21 percent change
Standard Deviation 4.83 • Interval 63.8 to 86.0
|
63.14 percent change
Standard Deviation 5.19
|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 20 (n = 38, 19)
|
65.56 percent change
Standard Deviation 4.75 • Interval 63.8 to 86.0
|
60.11 percent change
Standard Deviation 5.68
|
|
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
Week 24 (n = 37, 18)
|
65.30 percent change
Standard Deviation 5.68 • Interval 60.3 to 83.4
|
52.72 percent change
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Week 12Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
Outcome measures
| Measure |
Etanercept 50 mg
n=61 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Patient Satisfaction With Treatment at Week 12
Very dissatisfied
|
3.3 percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 11.3
|
—
|
|
Patient Satisfaction With Treatment at Week 12
Dissatisfied
|
13.1 percentage of participants
95% Confidence Interval 0.8 • Interval 5.8 to 24.2
|
—
|
|
Patient Satisfaction With Treatment at Week 12
Neither satisfied nor dissatisfied
|
21.3 percentage of participants
95% Confidence Interval 0.9 • Interval 11.9 to 33.7
|
—
|
|
Patient Satisfaction With Treatment at Week 12
Satisfied
|
29.5 percentage of participants
Interval 18.5 to 42.6
|
—
|
|
Patient Satisfaction With Treatment at Week 12
Very satisfied
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
Outcome measures
| Measure |
Etanercept 50 mg
n=62 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Patient Satisfaction With Treatment at Week 24
Very dissatisfied
|
9.7 percentage of participants
95% Confidence Interval 0.4 • Interval 3.6 to 19.9
|
—
|
|
Patient Satisfaction With Treatment at Week 24
Dissatisfied
|
21.0 percentage of participants
95% Confidence Interval 0.8 • Interval 11.7 to 33.2
|
—
|
|
Patient Satisfaction With Treatment at Week 24
Neither satisfied nor dissatisfied
|
16.1 percentage of participants
95% Confidence Interval 0.9 • Interval 8.0 to 27.7
|
—
|
|
Patient Satisfaction With Treatment at Week 24
Satisfied
|
29.0 percentage of participants
Interval 18.2 to 41.9
|
—
|
|
Patient Satisfaction With Treatment at Week 24
Very satisfied
|
24.2 percentage of participants
Interval 14.2 to 36.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=61 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Week 12 (n = 60)
|
7.9 units on a scale
Standard Deviation 7.9
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Week 24 (n = 61)
|
7.0 units on a scale
Standard Deviation 7.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 12: Absenteeism (n = 43)
|
1.35 units on a scale
Standard Deviation 5.03
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 24: Absenteeism (n = 43)
|
-1.62 units on a scale
Standard Deviation 15.87
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 12: Presenteeism (n = 38)
|
14.47 units on a scale
Standard Deviation 24.24
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 24: Presenteeism (n = 41)
|
11.22 units on a scale
Standard Deviation 19.65
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 12: Work Productivity Loss (n = 43)
|
13.13 units on a scale
Standard Deviation 25.12
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 24: Work Productivity Loss (n = 43)
|
8.93 units on a scale
Standard Deviation 21.68
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 12: Activity Impairment (n = 60)
|
24.17 units on a scale
Standard Deviation 29.24
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Week 24: Activity Impairment (n = 61)
|
17.87 units on a scale
Standard Deviation 26.59
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Change From Baseline in Patient Assessment of Itch
Week 12 (n = 60)
|
3.9 units on a scale
Standard Deviation 2.8
|
—
|
|
Change From Baseline in Patient Assessment of Itch
Week 24 (n = 61)
|
3.5 units on a scale
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Change From Baseline in Patient Assessment of Pain
Week 12 (n = 60)
|
3.4 units on a scale
Standard Deviation 3.1
|
—
|
|
Change From Baseline in Patient Assessment of Pain
Week 24 (n = 61)
|
3.0 units on a scale
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and 24Population: Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.
The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.
Outcome measures
| Measure |
Etanercept 50 mg
n=63 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Change From Baseline in Patient Assessment of Flaking
Week 12 (n = 60)
|
4.2 units on a scale
Standard Deviation 3.2
|
—
|
|
Change From Baseline in Patient Assessment of Flaking
Week 24 (n = 61)
|
3.6 units on a scale
Standard Deviation 3.6
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until 30 days after the last dose (up to 28 weeks)Population: Primary analysis set
A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.
Outcome measures
| Measure |
Etanercept 50 mg
n=64 Participants
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
Anti-adalimumab Antibody Negative
Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events
AE leading to discontinuation of study drug
|
1 participants
|
—
|
|
Number of Participants With Adverse Events
Any adverse event (AE)
|
40 participants
|
—
|
|
Number of Participants With Adverse Events
Serious adverse events
|
2 participants
|
—
|
|
Number of Participants With Adverse Events
AE leading to discontinuation from study
|
1 participants
|
—
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 participants
|
—
|
|
Number of Participants With Adverse Events
Treatment-related adverse events (TRAE)
|
16 participants
|
—
|
|
Number of Participants With Adverse Events
Serious treatment-related adverse events
|
1 participants
|
—
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation of study drug
|
1 participants
|
—
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation from study
|
1 participants
|
—
|
|
Number of Participants With Adverse Events
Fatal treatment-related adverse events
|
0 participants
|
—
|
Adverse Events
Etanercept 50mg BIW/50mg QW
Serious adverse events
| Measure |
Etanercept 50mg BIW/50mg QW
n=64 participants at risk
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.6%
1/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Etanercept 50mg BIW/50mg QW
n=64 participants at risk
Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.8%
5/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.8%
5/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
6/64 • From first dose of study drug until 30 days after the last dose (up to 28 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER