Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
Study Details
Study Description
Brief Summary
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Etanercept Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
Drug: Etanercept
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a PASI 75 Response at Week 12 [Baseline and 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.
Secondary Outcome Measures
- Percentage of Participants With a PASI 75 Response at Each Visit [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percentage of Participants With a PASI 50 Response at Each Visit [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percentage of Participants With a PASI 90 Response at Each Visit [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit [Weeks 4, 8, 12, 16, 20, and 24]
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).
- Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit [Weeks 4, 8, 12, 16, 20, and 24]
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.
- Static Physician Global Assessment (sPGA) at Each Visit [Weeks 4, 8, 12, 16, 20, and 24]
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).
- Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit [Baseline and weeks 4, 8, 12, 16, 20, and 24]
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.
- Psoriasis Symptom Inventory (PSI) Total Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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.
- PSI "Itch From Psoriasis" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Redness of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Scaling of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Burning of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Stinging of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Cracking of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Flaking of Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- PSI "Pain From Skin Lesions" Component Score at Each Visit [Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24]
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).
- Patient Assessment of Treatment Satisfaction at Week 12 [Week 12]
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
- Patient Assessment of Treatment Satisfaction at Week 24 [Week 24]
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24 [Baseline and weeks 12 and 24]
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.
- Number of Participants With Adverse Events [From first dose of etanercept to 30 days after last dose, up to 28 weeks.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has provided informed consent prior to initiation of any study specific activities/procedures
-
Male or female subject is ≥ 18 years of age at time of screening
-
Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
-
Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline
-
Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening
-
Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator
-
Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast)
-
Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment
-
Subject is < 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody
-
Subject has no known history of tuberculosis.
Exclusion Criteria:
Skin disease related
-Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO.
Other Medical Conditions
-
Subject has one or more significant concurrent medical conditions per investigator judgment, including the following
-
Poorly controlled diabetes
-
Chronic kidney disease stage IIIb, IV, or V
-
Symptomatic heart failure (New York Heart Association class II, III, or IV)
-
Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
-
Uncontrolled hypertension
-
Severe chronic pulmonary disease (eg, requiring oxygen therapy)
-
Multiple sclerosis or any other demyelinating disease
-
Liver disease
-
Anemia
-
Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome)
-
Subject has active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of investigational product.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Scottsdale | Arizona | United States | 85254 |
| 2 | Research Site | Beverly Hills | California | United States | 90211 |
| 3 | Research Site | Fountain Valley | California | United States | 92708 |
| 4 | Research Site | Newport Beach | California | United States | 92663 |
| 5 | Research Site | San Ramon | California | United States | 94583 |
| 6 | Research Site | Santa Monica | California | United States | 90404 |
| 7 | Research Site | Coral Gables | Florida | United States | 33134 |
| 8 | Research Site | Jacksonville | Florida | United States | 32204 |
| 9 | Research Site | Macon | Georgia | United States | 31217 |
| 10 | Research Site | Louisville | Kentucky | United States | 40217 |
| 11 | Research Site | Rockville | Maryland | United States | 20850 |
| 12 | Research Site | Ann Arbor | Michigan | United States | 48103 |
| 13 | Research Site | Clarkston | Michigan | United States | 48346 |
| 14 | Research Site | Fort Gratiot | Michigan | United States | 48059 |
| 15 | Research Site | Saint Louis | Missouri | United States | 63117 |
| 16 | Research Site | Henderson | Nevada | United States | 89052 |
| 17 | Research Site | East Windsor | New Jersey | United States | 08520 |
| 18 | Research Site | Verona | New Jersey | United States | 07044 |
| 19 | Research Site | New York | New York | United States | 10075 |
| 20 | Research Site | Greenville | North Carolina | United States | 27834 |
| 21 | Research Site | Houston | Texas | United States | 77082 |
| 22 | Research Site | San Antonio | Texas | United States | 78218 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Bagel J, Samad AS, Stolshek BS, Aras GA, Chung JB, Kricorian G, Kircik LH. Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast. J Drugs Dermatol. 2018 Oct 1;17(10):1078-1082.
- Bagel J, Stolshek BS, Yang Y, Kricorian G, Kircik LH. Evaluation of Patient-Reported Outcomes With Etanercept in Moderate to Severe Plaque Psoriasis Patients After Therapy With Apremilast. J Drugs Dermatol. 2020 Apr 1;19(4):378-383. doi: 10.36849/JDD.2020.4910.
- 20150252
Study Results
Participant Flow
| Recruitment Details | This study was conducted at 22 centers in the United States from 18 May 2016 to 06 December 2017. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Period Title: Overall Study | |
| STARTED | 80 |
| COMPLETED | 66 |
| NOT COMPLETED | 14 |
Baseline Characteristics
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Overall Participants | 80 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
50.4
(14.8)
|
| Age, Customized (Count of Participants) | |
| < 65 years |
63
78.8%
|
| ≥ 65 years |
17
21.3%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
33
41.3%
|
| Male |
47
58.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
19
23.8%
|
| Not Hispanic or Latino |
61
76.3%
|
| Unknown or Not Reported |
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| American Indian or Alaska Native |
4
5%
|
| Asian |
11
13.8%
|
| Black or African American |
2
2.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| White |
60
75%
|
| Other |
3
3.8%
|
| Psoriasis Area Severity Index (PASI) Score (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
16.4
(6.5)
|
| Percent of Body Surface Area (BSA) Involved in Psoriasis (Percentage of BSA) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Percentage of BSA] |
16.4
(10.5)
|
| Static Physician Global Assessment (sPGA) of Psoriasis (Count of Participants) | |
| 0 = Clear |
0
0%
|
| 1 = Almost clear |
0
0%
|
| 2 = Mild |
0
0%
|
| 3 = Moderate |
51
63.8%
|
| 4 = Severe |
28
35%
|
| 5 = Very Severe |
1
1.3%
|
| Dermatology Life Quality Index (DLQI) (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
12.5
(7.4)
|
| Psoriasis Symptom Inventory (PSI) (units on a scale) [Mean (Standard Deviation) ] | |
| Total score |
16.6
(6.6)
|
| Itch from psoriasis |
2.5
(1.0)
|
| Redness of skin lesions |
2.6
(0.9)
|
| Scaling of skin lesions |
2.6
(0.8)
|
| Burning of skin lesions |
1.4
(1.2)
|
| Stinging of skin lesions |
1.5
(1.2)
|
| Cracking of skin lesions |
2.0
(1.0)
|
| Flaking of skin lesions |
2.5
(1.9)
|
| Pain from skin lesions |
1.5
(1.1)
|
| Patient Assessment of Treatment Satisfaction (Count of Participants) | |
| Very dissatisfied |
33
41.3%
|
| Dissatisfied |
13
16.3%
|
| Neither satisfied nor dissatisfied |
30
37.5%
|
| Satisfied |
4
5%
|
| Very satisfied |
0
0%
|
Outcome Measures
| Title | Percentage of Participants With a PASI 75 Response at Week 12 |
|---|---|
| Description | 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. |
| Time Frame | Baseline and week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Number (95% Confidence Interval) [percentage of participants] |
41.6
52%
|
| Title | Percentage of Participants With a PASI 75 Response at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
6.6
8.3%
|
| Week 8 |
23.4
29.3%
|
| Week 12 |
41.6
52%
|
| Week 16 |
42.9
53.6%
|
| Week 20 |
42.9
53.6%
|
| Week 24 |
45.5
56.9%
|
| Title | Percentage of Participants With a PASI 50 Response at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
23.7
29.6%
|
| Week 8 |
50.6
63.3%
|
| Week 12 |
70.1
87.6%
|
| Week 16 |
68.8
86%
|
| Week 20 |
74.0
92.5%
|
| Week 24 |
62.3
77.9%
|
| Title | Percentage of Participants With a PASI 90 Response at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
1.3
1.6%
|
| Week 8 |
6.5
8.1%
|
| Week 12 |
13.0
16.3%
|
| Week 16 |
16.9
21.1%
|
| Week 20 |
23.4
29.3%
|
| Week 24 |
22.1
27.6%
|
| Title | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
22.03
(33.58)
|
| Week 8 |
43.51
(40.53)
|
| Week 12 |
55.47
(48.16)
|
| Week 16 |
57.41
(40.79)
|
| Week 20 |
60.42
(39.12)
|
| Week 24 |
57.67
(40.20)
|
| Title | Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
3.9
4.9%
|
| Week 8 |
15.6
19.5%
|
| Week 12 |
23.4
29.3%
|
| Week 16 |
28.6
35.8%
|
| Week 20 |
29.9
37.4%
|
| Week 24 |
33.8
42.3%
|
| Title | Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
21.1
26.4%
|
| Week 8 |
55.8
69.8%
|
| Week 12 |
62.3
77.9%
|
| Week 16 |
59.7
74.6%
|
| Week 20 |
55.8
69.8%
|
| Week 24 |
57.1
71.4%
|
| Title | Static Physician Global Assessment (sPGA) at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
2.9
(0.7)
|
| Week 8 |
2.4
(0.9)
|
| Week 12 |
2.2
(1.0)
|
| Week 16 |
2.2
(1.1)
|
| Week 20 |
2.2
(1.1)
|
| Week 24 |
2.2
(1.2)
|
| Title | Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
40.8
51%
|
| Week 8 |
70.1
87.6%
|
| Week 12 |
75.3
94.1%
|
| Week 16 |
72.7
90.9%
|
| Week 20 |
74.0
92.5%
|
| Week 24 |
74.0
92.5%
|
| Title | Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
7.9
9.9%
|
| Week 8 |
31.2
39%
|
| Week 12 |
32.5
40.6%
|
| Week 16 |
37.7
47.1%
|
| Week 20 |
36.4
45.5%
|
| Week 24 |
39.0
48.8%
|
| Title | Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 4 |
13.47
(24.63)
|
| Week 8 |
31.03
(37.52)
|
| Week 12 |
44.49
(40.29)
|
| Week 16 |
48.26
(39.80)
|
| Week 20 |
49.97
(40.15)
|
| Week 24 |
46.89
(42.70)
|
| Title | Psoriasis Symptom Inventory (PSI) Total Score at Each Visit |
|---|---|
| Description | 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. |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
14.7
(7.1)
|
| Week 2 |
13.7
(6.5)
|
| Week 3 |
12.1
(6.1)
|
| Week 4 |
11.7
(6.6)
|
| Week 8 |
10.0
(5.9)
|
| Week 12 |
8.8
(6.4)
|
| Week 16 |
10.1
(7.6)
|
| Week 20 |
9.9
(7.8)
|
| Week 24 |
9.6
(7.7)
|
| Title | PSI "Itch From Psoriasis" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
2.2
(1.0)
|
| Week 2 |
2.0
(0.9)
|
| Week 3 |
1.9
(0.8)
|
| Week 4 |
1.8
(0.9)
|
| Week 8 |
1.5
(0.9)
|
| Week 12 |
1.3
(0.9)
|
| Week 16 |
1.5
(1.0)
|
| Week 20 |
1.5
(1.1)
|
| Week 24 |
1.5
(1.0)
|
| Title | PSI "Redness of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
2.4
(0.9)
|
| Week 2 |
2.2
(0.9)
|
| Week 3 |
2.0
(0.8)
|
| Week 4 |
1.8
(0.9)
|
| Week 8 |
1.7
(0.9)
|
| Week 12 |
1.5
(1.0)
|
| Week 16 |
1.7
(1.1)
|
| Week 20 |
1.5
(1.1)
|
| Week 24 |
1.5
(1.1)
|
| Title | PSI "Scaling of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
2.3
(1.0)
|
| Week 2 |
2.1
(1.1)
|
| Week 3 |
1.9
(0.9)
|
| Week 4 |
1.9
(0.9)
|
| Week 8 |
1.6
(0.9)
|
| Week 12 |
1.5
(0.9)
|
| Week 16 |
1.6
(1.0)
|
| Week 20 |
1.6
(1.1)
|
| Week 24 |
1.4
(1.1)
|
| Title | PSI "Burning of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
1.3
(1.1)
|
| Week 2 |
1.2
(1.1)
|
| Week 3 |
1.0
(1.0)
|
| Week 4 |
1.0
(1.0)
|
| Week 8 |
0.8
(0.9)
|
| Week 12 |
0.8
(1.0)
|
| Week 16 |
0.9
(1.1)
|
| Week 20 |
0.9
(1.1)
|
| Week 24 |
0.9
(1.1)
|
| Title | PSI "Stinging of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
1.2
(1.2)
|
| Week 2 |
1.1
(1.0)
|
| Week 3 |
1.0
(1.0)
|
| Week 4 |
1.0
(1.1)
|
| Week 8 |
0.8
(0.9)
|
| Week 12 |
0.7
(0.9)
|
| Week 16 |
0.9
(1.1)
|
| Week 20 |
0.9
(1.1)
|
| Week 24 |
0.8
(1.1)
|
| Title | PSI "Cracking of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
1.9
(1.1)
|
| Week 2 |
1.7
(1.0)
|
| Week 3 |
1.6
(1.0)
|
| Week 4 |
1.4
(1.1)
|
| Week 8 |
1.2
(1.0)
|
| Week 12 |
1.1
(1.0)
|
| Week 16 |
1.2
(1.0)
|
| Week 20 |
1.2
(1.1)
|
| Week 24 |
1.2
(1.1)
|
| Title | PSI "Flaking of Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
2.2
(0.9)
|
| Week 2 |
2.1
(0.9)
|
| Week 3 |
1.8
(0.9)
|
| Week 4 |
1.8
(1.0)
|
| Week 8 |
1.5
(1.0)
|
| Week 12 |
1.3
(1.0)
|
| Week 16 |
1.5
(1.1)
|
| Week 20 |
1.6
(1.1)
|
| Week 24 |
1.4
(1.1)
|
| Title | PSI "Pain From Skin Lesions" Component Score at Each Visit |
|---|---|
| Description | 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). |
| Time Frame | Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 77 |
| Week 1 |
1.2
(1.2)
|
| Week 2 |
1.2
(1.1)
|
| Week 3 |
1.0
(1.0)
|
| Week 4 |
1.0
(1.0)
|
| Week 8 |
0.8
(0.9)
|
| Week 12 |
0.7
(0.9)
|
| Week 16 |
0.9
(1.1)
|
| Week 20 |
0.9
(1.1)
|
| Week 24 |
0.8
(1.0)
|
| Title | Patient Assessment of Treatment Satisfaction at Week 12 |
|---|---|
| Description | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied". |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 74 |
| Very dissatisfied |
4.1
5.1%
|
| Dissatisfied |
13.5
16.9%
|
| Neither satisfied nor dissatisfied |
21.6
27%
|
| Satisfied |
32.4
40.5%
|
| Very satisfied |
28.4
35.5%
|
| Title | Patient Assessment of Treatment Satisfaction at Week 24 |
|---|---|
| Description | Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied". |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 75 |
| Very dissatisfied |
8.0
10%
|
| Dissatisfied |
25.3
31.6%
|
| Neither satisfied nor dissatisfied |
13.3
16.6%
|
| Satisfied |
24.0
30%
|
| Very satisfied |
29.3
36.6%
|
| Title | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline and weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 75 |
| Week 12 |
53.60
(35.46)
|
| Week 24 |
36.95
(92.77)
|
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | |
| Time Frame | From first dose of etanercept to 30 days after last dose, up to 28 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least 1 dose of etanercept during the study. |
| Arm/Group Title | Etanercept |
|---|---|
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. |
| Measure Participants | 80 |
| All adverse events (AEs) |
19
23.8%
|
| Serious adverse events |
2
2.5%
|
| AEs leading to discontinuation of etanercept |
2
2.5%
|
| Fatal adverse events |
0
0%
|
| Treatment-related adverse events (TRAEs) |
10
12.5%
|
| Treatment-related serious adverse events |
1
1.3%
|
| TRAEs leading to discontinuation of etanercept |
1
1.3%
|
| Fatal treatment-related adverse events |
0
0%
|
Adverse Events
| Time Frame | From first dose of etanercept to 30 days after last dose, up to 28 weeks. | |
|---|---|---|
| Adverse Event Reporting Description | Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. | |
| Arm/Group Title | Etanercept | |
| Arm/Group Description | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. | |
All Cause Mortality |
||
| Etanercept | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | |
Serious Adverse Events |
||
| Etanercept | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/80 (2.5%) | |
| General disorders | ||
| Injection site reaction | 1/80 (1.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Drug eruption | 2/80 (2.5%) | |
Other (Not Including Serious) Adverse Events |
||
| Etanercept | ||
| Affected / at Risk (%) | # Events | |
| Total | 18/80 (22.5%) | |
| Gastrointestinal disorders | ||
| Diarrhoea | 1/80 (1.3%) | |
| General disorders | ||
| Injection site hypersensitivity | 1/80 (1.3%) | |
| Injection site reaction | 2/80 (2.5%) | |
| Injection site swelling | 1/80 (1.3%) | |
| Pyrexia | 1/80 (1.3%) | |
| Infections and infestations | ||
| Nasopharyngitis | 1/80 (1.3%) | |
| Pneumonia | 1/80 (1.3%) | |
| Sinobronchitis | 1/80 (1.3%) | |
| Sinusitis | 1/80 (1.3%) | |
| Tonsillitis | 1/80 (1.3%) | |
| Upper respiratory tract infection | 2/80 (2.5%) | |
| Injury, poisoning and procedural complications | ||
| Injection related reaction | 2/80 (2.5%) | |
| Meniscus injury | 1/80 (1.3%) | |
| Investigations | ||
| Blood pressure increased | 1/80 (1.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 2/80 (2.5%) | |
| Exostosis | 2/80 (2.5%) | |
| Psoriatic arthropathy | 1/80 (1.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Benign neoplasm of bladder | 1/80 (1.3%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 1/80 (1.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma | 1/80 (1.3%) | |
| Cough | 1/80 (1.3%) | |
| Oropharyngeal pain | 1/80 (1.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Actinic keratosis | 1/80 (1.3%) | |
| Vascular disorders | ||
| Hypertension | 1/80 (1.3%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Amgen Inc. |
| Phone | 866-572-6436 |
| medinfo@amgen.com |
- 20150252