Trial Outcomes & Findings for Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast (NCT NCT02749370)
NCT ID: NCT02749370
Last Updated: 2020-05-13
Results Overview
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.
COMPLETED
PHASE4
80 participants
Baseline and week 12
2020-05-13
Participant Flow
This study was conducted at 22 centers in the United States from 18 May 2016 to 06 December 2017.
Participant milestones
| Measure |
Etanercept
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Etanercept
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
Baseline characteristics by cohort
| Measure |
Etanercept
n=80 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 14.8 • n=93 Participants
|
|
Age, Customized
< 65 years
|
63 Participants
n=93 Participants
|
|
Age, Customized
≥ 65 years
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
|
Psoriasis Area Severity Index (PASI) Score
|
16.4 units on a scale
STANDARD_DEVIATION 6.5 • n=93 Participants
|
|
Percent of Body Surface Area (BSA) Involved in Psoriasis
|
16.4 Percentage of BSA
STANDARD_DEVIATION 10.5 • n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
0 = Clear
|
0 Participants
n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
1 = Almost clear
|
0 Participants
n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
2 = Mild
|
0 Participants
n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
3 = Moderate
|
51 Participants
n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
4 = Severe
|
28 Participants
n=93 Participants
|
|
Static Physician Global Assessment (sPGA) of Psoriasis
5 = Very Severe
|
1 Participants
n=93 Participants
|
|
Dermatology Life Quality Index (DLQI)
|
12.5 units on a scale
STANDARD_DEVIATION 7.4 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Total score
|
16.6 units on a scale
STANDARD_DEVIATION 6.6 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Itch from psoriasis
|
2.5 units on a scale
STANDARD_DEVIATION 1.0 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Redness of skin lesions
|
2.6 units on a scale
STANDARD_DEVIATION 0.9 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Scaling of skin lesions
|
2.6 units on a scale
STANDARD_DEVIATION 0.8 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Burning of skin lesions
|
1.4 units on a scale
STANDARD_DEVIATION 1.2 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Stinging of skin lesions
|
1.5 units on a scale
STANDARD_DEVIATION 1.2 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Cracking of skin lesions
|
2.0 units on a scale
STANDARD_DEVIATION 1.0 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Flaking of skin lesions
|
2.5 units on a scale
STANDARD_DEVIATION 1.9 • n=93 Participants
|
|
Psoriasis Symptom Inventory (PSI)
Pain from skin lesions
|
1.5 units on a scale
STANDARD_DEVIATION 1.1 • n=93 Participants
|
|
Patient Assessment of Treatment Satisfaction
Very dissatisfied
|
33 Participants
n=93 Participants
|
|
Patient Assessment of Treatment Satisfaction
Dissatisfied
|
13 Participants
n=93 Participants
|
|
Patient Assessment of Treatment Satisfaction
Neither satisfied nor dissatisfied
|
30 Participants
n=93 Participants
|
|
Patient Assessment of Treatment Satisfaction
Satisfied
|
4 Participants
n=93 Participants
|
|
Patient Assessment of Treatment Satisfaction
Very satisfied
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used for participants with missing data at week 12.
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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 75 Response at Week 12
|
41.6 percentage of participants
Interval 30.4 to 53.4
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 4
|
6.6 percentage of participants
Interval 2.2 to 14.7
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 8
|
23.4 percentage of participants
Interval 14.5 to 34.4
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 12
|
41.6 percentage of participants
Interval 30.4 to 53.4
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 16
|
42.9 percentage of participants
Interval 31.6 to 54.6
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 20
|
42.9 percentage of participants
Interval 31.6 to 54.6
|
|
Percentage of Participants With a PASI 75 Response at Each Visit
Week 24
|
45.5 percentage of participants
Interval 34.1 to 57.2
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 4
|
23.7 percentage of participants
Interval 14.7 to 34.8
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 8
|
50.6 percentage of participants
Interval 39.0 to 62.2
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 12
|
70.1 percentage of participants
Interval 58.6 to 80.0
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 16
|
68.8 percentage of participants
Interval 57.3 to 78.9
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 20
|
74.0 percentage of participants
Interval 62.8 to 83.4
|
|
Percentage of Participants With a PASI 50 Response at Each Visit
Week 24
|
62.3 percentage of participants
Interval 50.6 to 73.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 16
|
16.9 percentage of participants
Interval 9.3 to 27.1
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 20
|
23.4 percentage of participants
Interval 14.5 to 34.4
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 24
|
22.1 percentage of participants
Interval 13.4 to 33.0
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 4
|
1.3 percentage of participants
Interval 0.0 to 7.1
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 8
|
6.5 percentage of participants
Interval 2.1 to 14.5
|
|
Percentage of Participants With a PASI 90 Response at Each Visit
Week 12
|
13.0 percentage of participants
Interval 6.4 to 22.6
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 4
|
22.03 percent change
Standard Deviation 33.58
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 8
|
43.51 percent change
Standard Deviation 40.53
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 12
|
55.47 percent change
Standard Deviation 48.16
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 16
|
57.41 percent change
Standard Deviation 40.79
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 20
|
60.42 percent change
Standard Deviation 39.12
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Week 24
|
57.67 percent change
Standard Deviation 40.20
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 4
|
3.9 percentage of participants
Interval 0.8 to 11.1
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 8
|
15.6 percentage of participants
Interval 8.3 to 25.6
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 12
|
23.4 percentage of participants
Interval 14.5 to 34.4
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 16
|
28.6 percentage of participants
Interval 18.8 to 40.0
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 20
|
29.9 percentage of participants
Interval 20.0 to 41.4
|
|
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Week 24
|
33.8 percentage of participants
Interval 23.4 to 45.4
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 4
|
21.1 percentage of participants
Interval 12.5 to 31.9
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 8
|
55.8 percentage of participants
Interval 44.1 to 67.2
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 12
|
62.3 percentage of participants
Interval 50.6 to 73.1
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 16
|
59.7 percentage of participants
Interval 47.9 to 70.8
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 20
|
55.8 percentage of participants
Interval 44.1 to 67.2
|
|
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Week 24
|
57.1 percentage of participants
Interval 45.4 to 68.4
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 4
|
2.9 units on a scale
Standard Deviation 0.7
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 24
|
2.2 units on a scale
Standard Deviation 1.2
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 8
|
2.4 units on a scale
Standard Deviation 0.9
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 12
|
2.2 units on a scale
Standard Deviation 1.0
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 16
|
2.2 units on a scale
Standard Deviation 1.1
|
|
Static Physician Global Assessment (sPGA) at Each Visit
Week 20
|
2.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 20
|
74.0 percentage of participants
Interval 62.8 to 83.4
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 4
|
40.8 percentage of participants
Interval 29.6 to 52.7
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 8
|
70.1 percentage of participants
Interval 58.6 to 80.0
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 12
|
75.3 percentage of participants
Interval 64.2 to 84.4
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 16
|
72.7 percentage of participants
Interval 61.4 to 82.3
|
|
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
Week 24
|
74.0 percentage of participants
Interval 62.8 to 83.4
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least I post-baseline sPGA value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 16
|
37.7 percentage of participants
Interval 26.9 to 49.4
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 4
|
7.9 percentage of participants
Interval 3.0 to 16.4
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 8
|
31.2 percentage of participants
Interval 21.1 to 42.7
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 12
|
32.5 percentage of participants
Interval 22.2 to 44.1
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 20
|
36.4 percentage of participants
Interval 25.7 to 48.1
|
|
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
Week 24
|
39.0 percentage of participants
Interval 28.0 to 50.8
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (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
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 16
|
48.26 percent change
Standard Deviation 39.80
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 20
|
49.97 percent change
Standard Deviation 40.15
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 24
|
46.89 percent change
Standard Deviation 42.70
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 4
|
13.47 percent change
Standard Deviation 24.63
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 8
|
31.03 percent change
Standard Deviation 37.52
|
|
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
Week 12
|
44.49 percent change
Standard Deviation 40.29
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 1
|
14.7 units on a scale
Standard Deviation 7.1
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 2
|
13.7 units on a scale
Standard Deviation 6.5
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 3
|
12.1 units on a scale
Standard Deviation 6.1
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 4
|
11.7 units on a scale
Standard Deviation 6.6
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 8
|
10.0 units on a scale
Standard Deviation 5.9
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 12
|
8.8 units on a scale
Standard Deviation 6.4
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 16
|
10.1 units on a scale
Standard Deviation 7.6
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 20
|
9.9 units on a scale
Standard Deviation 7.8
|
|
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Week 24
|
9.6 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 24
|
1.5 units on a scale
Standard Deviation 1.0
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 1
|
2.2 units on a scale
Standard Deviation 1.0
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 2
|
2.0 units on a scale
Standard Deviation 0.9
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 3
|
1.9 units on a scale
Standard Deviation 0.8
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 4
|
1.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 8
|
1.5 units on a scale
Standard Deviation 0.9
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 12
|
1.3 units on a scale
Standard Deviation 0.9
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 16
|
1.5 units on a scale
Standard Deviation 1.0
|
|
PSI "Itch From Psoriasis" Component Score at Each Visit
Week 20
|
1.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 1
|
2.4 units on a scale
Standard Deviation 0.9
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 2
|
2.2 units on a scale
Standard Deviation 0.9
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 3
|
2.0 units on a scale
Standard Deviation 0.8
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 4
|
1.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 8
|
1.7 units on a scale
Standard Deviation 0.9
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 12
|
1.5 units on a scale
Standard Deviation 1.0
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 16
|
1.7 units on a scale
Standard Deviation 1.1
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 20
|
1.5 units on a scale
Standard Deviation 1.1
|
|
PSI "Redness of Skin Lesions" Component Score at Each Visit
Week 24
|
1.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 2
|
2.1 units on a scale
Standard Deviation 1.1
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 1
|
2.3 units on a scale
Standard Deviation 1.0
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 3
|
1.9 units on a scale
Standard Deviation 0.9
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 4
|
1.9 units on a scale
Standard Deviation 0.9
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 8
|
1.6 units on a scale
Standard Deviation 0.9
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 12
|
1.5 units on a scale
Standard Deviation 0.9
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 16
|
1.6 units on a scale
Standard Deviation 1.0
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 20
|
1.6 units on a scale
Standard Deviation 1.1
|
|
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Week 24
|
1.4 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 3
|
1.0 units on a scale
Standard Deviation 1.0
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 1
|
1.3 units on a scale
Standard Deviation 1.1
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 2
|
1.2 units on a scale
Standard Deviation 1.1
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 4
|
1.0 units on a scale
Standard Deviation 1.0
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 8
|
0.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 12
|
0.8 units on a scale
Standard Deviation 1.0
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 16
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 20
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Burning of Skin Lesions" Component Score at Each Visit
Week 24
|
0.9 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 1
|
1.2 units on a scale
Standard Deviation 1.2
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 2
|
1.1 units on a scale
Standard Deviation 1.0
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 3
|
1.0 units on a scale
Standard Deviation 1.0
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 4
|
1.0 units on a scale
Standard Deviation 1.1
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 8
|
0.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 12
|
0.7 units on a scale
Standard Deviation 0.9
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 16
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 20
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Week 24
|
0.8 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 1
|
1.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 2
|
1.7 units on a scale
Standard Deviation 1.0
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 3
|
1.6 units on a scale
Standard Deviation 1.0
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 4
|
1.4 units on a scale
Standard Deviation 1.1
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 8
|
1.2 units on a scale
Standard Deviation 1.0
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 12
|
1.1 units on a scale
Standard Deviation 1.0
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 16
|
1.2 units on a scale
Standard Deviation 1.0
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 20
|
1.2 units on a scale
Standard Deviation 1.1
|
|
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Week 24
|
1.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 1
|
2.2 units on a scale
Standard Deviation 0.9
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 2
|
2.1 units on a scale
Standard Deviation 0.9
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 3
|
1.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 4
|
1.8 units on a scale
Standard Deviation 1.0
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 8
|
1.5 units on a scale
Standard Deviation 1.0
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 12
|
1.3 units on a scale
Standard Deviation 1.0
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 16
|
1.5 units on a scale
Standard Deviation 1.1
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 20
|
1.6 units on a scale
Standard Deviation 1.1
|
|
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Week 24
|
1.4 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Outcome measures
| Measure |
Etanercept
n=77 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 1
|
1.2 units on a scale
Standard Deviation 1.2
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 2
|
1.2 units on a scale
Standard Deviation 1.1
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 3
|
1.0 units on a scale
Standard Deviation 1.0
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 4
|
1.0 units on a scale
Standard Deviation 1.0
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 8
|
0.8 units on a scale
Standard Deviation 0.9
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 12
|
0.7 units on a scale
Standard Deviation 0.9
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 16
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 20
|
0.9 units on a scale
Standard Deviation 1.1
|
|
PSI "Pain From Skin Lesions" Component Score at Each Visit
Week 24
|
0.8 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 12Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (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
n=74 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Patient Assessment of Treatment Satisfaction at Week 12
Very dissatisfied
|
4.1 percentage of participants
Interval 0.8 to 11.4
|
|
Patient Assessment of Treatment Satisfaction at Week 12
Dissatisfied
|
13.5 percentage of participants
Interval 6.7 to 23.5
|
|
Patient Assessment of Treatment Satisfaction at Week 12
Neither satisfied nor dissatisfied
|
21.6 percentage of participants
Interval 12.9 to 32.7
|
|
Patient Assessment of Treatment Satisfaction at Week 12
Satisfied
|
32.4 percentage of participants
Interval 22.0 to 44.3
|
|
Patient Assessment of Treatment Satisfaction at Week 12
Very satisfied
|
28.4 percentage of participants
Interval 18.5 to 40.1
|
SECONDARY outcome
Timeframe: Week 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (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
n=75 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Patient Assessment of Treatment Satisfaction at Week 24
Dissatisfied
|
25.3 percentage of participants
Interval 16.0 to 36.7
|
|
Patient Assessment of Treatment Satisfaction at Week 24
Neither satisfied nor dissatisfied
|
13.3 percentage of participants
Interval 6.6 to 23.2
|
|
Patient Assessment of Treatment Satisfaction at Week 24
Very dissatisfied
|
8.0 percentage of participants
Interval 3.0 to 16.6
|
|
Patient Assessment of Treatment Satisfaction at Week 24
Satisfied
|
24.0 percentage of participants
Interval 14.9 to 35.3
|
|
Patient Assessment of Treatment Satisfaction at Week 24
Very satisfied
|
29.3 percentage of participants
Interval 19.4 to 41.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 and 24Population: Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.
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). 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
n=75 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24
Week 12
|
53.60 percent change
Standard Deviation 35.46
|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24
Week 24
|
36.95 percent change
Standard Deviation 92.77
|
SECONDARY outcome
Timeframe: From first dose of etanercept to 30 days after last dose, up to 28 weeks.Population: Participants who received at least 1 dose of etanercept during the study.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Number of Participants With Adverse Events
All adverse events (AEs)
|
19 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
2 Participants
|
|
Number of Participants With Adverse Events
AEs leading to discontinuation of etanercept
|
2 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events (TRAEs)
|
10 Participants
|
|
Number of Participants With Adverse Events
Treatment-related serious adverse events
|
1 Participants
|
|
Number of Participants With Adverse Events
TRAEs leading to discontinuation of etanercept
|
1 Participants
|
|
Number of Participants With Adverse Events
Fatal treatment-related adverse events
|
0 Participants
|
Adverse Events
Etanercept
Serious adverse events
| Measure |
Etanercept
n=80 participants at risk
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
General disorders
Injection site reaction
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.5%
2/80 • From first dose of etanercept to 30 days after 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
n=80 participants at risk
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site hypersensitivity
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site reaction
|
2.5%
2/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site swelling
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Nasopharyngitis
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Pneumonia
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Sinobronchitis
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Sinusitis
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Tonsillitis
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Upper respiratory tract infection
|
2.5%
2/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
2.5%
2/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
2/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.5%
2/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Asthma
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
Oropharyngeal pain
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.2%
1/80 • From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
1.2%
1/80 • From first dose of etanercept to 30 days after 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
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