A Phase 4 interventional study of Etanercept in Plaque Psoriasis, sponsored by Amgen. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Amgen · Phase 4, Interventional, and Treatment
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
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.
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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
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.
Also known as: Enbrel
Percentage of Participants With a PASI 75 Response 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.
Time frame: Baseline and week 12
Percentage of Participants With a PASI 75 Response at Each Visit
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
Percentage of Participants With a PASI 50 Response at Each Visit
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
Percentage of Participants With a PASI 90 Response at Each Visit
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
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
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
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
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
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
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
Static Physician Global Assessment (sPGA) at Each Visit
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
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
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
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
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
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
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
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
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
PSI "Itch From Psoriasis" Component Score at Each Visit
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
PSI "Redness of Skin Lesions" Component Score at Each Visit
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
PSI "Scaling of Skin Lesions" Component Score at Each Visit
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
PSI "Burning of Skin Lesions" Component Score at Each Visit
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
PSI "Stinging of Skin Lesions" Component Score at Each Visit
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
PSI "Cracking of Skin Lesions" Component Score at Each Visit
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
PSI "Flaking of Skin Lesions" Component Score at Each Visit
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
PSI "Pain From Skin Lesions" Component Score at Each Visit
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
Patient Assessment of Treatment Satisfaction at Week 12
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
Patient Assessment of Treatment Satisfaction at Week 24
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
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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.
Time frame: Baseline and weeks 12 and 24
Number of Participants With Adverse Events
Time frame: From first dose of etanercept to 30 days after last dose, up to 28 weeks.
This study was conducted at 22 centers in the United States from 18 May 2016 to 06 December 2017.
| Milestone | Etanercept |
|---|---|
| Started | 80 |
| Completed | 66 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Lost to follow-up | 3 |
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 | Etanercept |
|---|---|
| Percentage of Participants With a PASI 75 Response at Week 12 | 41.6 (30.4 to 53.4) |
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 | Etanercept |
|---|---|
| Week 4 | 6.6 (2.2 to 14.7) |
| Week 8 | 23.4 (14.5 to 34.4) |
| Week 12 | 41.6 (30.4 to 53.4) |
| Week 16 | 42.9 (31.6 to 54.6) |
| Week 20 | 42.9 (31.6 to 54.6) |
| Week 24 | 45.5 (34.1 to 57.2) |
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 | Etanercept |
|---|---|
| Week 4 | 23.7 (14.7 to 34.8) |
| Week 8 | 50.6 (39.0 to 62.2) |
| Week 12 | 70.1 (58.6 to 80.0) |
| Week 16 | 68.8 (57.3 to 78.9) |
| Week 20 | 74.0 (62.8 to 83.4) |
| Week 24 | 62.3 (50.6 to 73.1) |
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.
| percentage of participants | Etanercept |
|---|---|
| Week 4 | 1.3 (0.0 to 7.1) |
| Week 8 | 6.5 (2.1 to 14.5) |
| Week 12 | 13.0 (6.4 to 22.6) |
| Week 16 | 16.9 (9.3 to 27.1) |
| Week 20 | 23.4 (14.5 to 34.4) |
| Week 24 | 22.1 (13.4 to 33.0) |
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.
| percent change | Etanercept |
|---|---|
| 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 |
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 | Etanercept |
|---|---|
| Week 4 | 3.9 (0.8 to 11.1) |
| Week 8 | 15.6 (8.3 to 25.6) |
| Week 12 | 23.4 (14.5 to 34.4) |
| Week 16 | 28.6 (18.8 to 40.0) |
| Week 20 | 29.9 (20.0 to 41.4) |
| Week 24 | 33.8 (23.4 to 45.4) |
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.
| percentage of participants | Etanercept |
|---|---|
| Week 4 | 21.1 (12.5 to 31.9) |
| Week 8 | 55.8 (44.1 to 67.2) |
| Week 12 | 62.3 (50.6 to 73.1) |
| Week 16 | 59.7 (47.9 to 70.8) |
| Week 20 | 55.8 (44.1 to 67.2) |
| Week 24 | 57.1 (45.4 to 68.4) |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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 | Etanercept |
|---|---|
| Week 4 | 40.8 (29.6 to 52.7) |
| Week 8 | 70.1 (58.6 to 80.0) |
| Week 12 | 75.3 (64.2 to 84.4) |
| Week 16 | 72.7 (61.4 to 82.3) |
| Week 20 | 74.0 (62.8 to 83.4) |
| Week 24 | 74.0 (62.8 to 83.4) |
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.
| percentage of participants | Etanercept |
|---|---|
| Week 4 | 7.9 (3.0 to 16.4) |
| Week 8 | 31.2 (21.1 to 42.7) |
| Week 12 | 32.5 (22.2 to 44.1) |
| Week 16 | 37.7 (26.9 to 49.4) |
| Week 20 | 36.4 (25.7 to 48.1) |
| Week 24 | 39.0 (28.0 to 50.8) |
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.
| percent change | Etanercept |
|---|---|
| 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 |
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.
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
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).
| units on a scale | Etanercept |
|---|---|
| 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 |
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
| percentage of participants | Etanercept |
|---|---|
| Very dissatisfied | 4.1 (0.8 to 11.4) |
| Dissatisfied | 13.5 (6.7 to 23.5) |
| Neither satisfied nor dissatisfied | 21.6 (12.9 to 32.7) |
| Satisfied | 32.4 (22.0 to 44.3) |
| Very satisfied | 28.4 (18.5 to 40.1) |
Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
| percentage of participants | Etanercept |
|---|---|
| Very dissatisfied | 8.0 (3.0 to 16.6) |
| Dissatisfied | 25.3 (16.0 to 36.7) |
| Neither satisfied nor dissatisfied | 13.3 (6.6 to 23.2) |
| Satisfied | 24.0 (14.9 to 35.3) |
| Very satisfied | 29.3 (19.4 to 41.0) |
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.
| percent change | Etanercept |
|---|---|
| Week 12 | 53.60 ± 35.46 |
| Week 24 | 36.95 ± 92.77 |
| Participants | Etanercept |
|---|---|
| All adverse events (AEs) | 19 |
| Serious adverse events | 2 |
| AEs leading to discontinuation of etanercept | 2 |
| Fatal adverse events | 0 |
| Treatment-related adverse events (TRAEs) | 10 |
| Treatment-related serious adverse events | 1 |
| TRAEs leading to discontinuation of etanercept | 1 |
| Fatal treatment-related adverse events | 0 |
Collected over From first dose of etanercept to 30 days after last dose, up to 28 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etanercept | 0/80 (0%) | 2/80 (2.5%) | 18/80 (22.5%) |
| Event | Etanercept |
|---|---|
| Drug eruptionSkin and subcutaneous tissue disorders | 2/80 |
| Injection site reactionGeneral disorders | 1/80 |
| Event | Etanercept |
|---|---|
| Injection site reactionGeneral disorders | 2/80 |
| Upper respiratory tract infectionInfections and infestations | 2/80 |
| Injection related reactionInjury, poisoning and procedural complications | 2/80 |
| Back painMusculoskeletal and connective tissue disorders | 2/80 |
| ExostosisMusculoskeletal and connective tissue disorders | 2/80 |
| DiarrhoeaGastrointestinal disorders | 1/80 |
| Injection site hypersensitivityGeneral disorders | 1/80 |
| Injection site swellingGeneral disorders | 1/80 |
| PyrexiaGeneral disorders | 1/80 |
| NasopharyngitisInfections and infestations | 1/80 |
| Age, Continuous(years) | Etanercept |
|---|---|
| Mean | 50.4 ± 14.8 |
| Age, Customized(Participants) | Etanercept |
|---|---|
| < 65 years | 63 |
| ≥ 65 years | 17 |
| Sex: Female, Male(Participants) | Etanercept |
|---|---|
| Female | 33 |
| Male | 47 |
| Ethnicity (NIH/OMB)(Participants) | Etanercept |
|---|---|
| Hispanic or Latino | 19 |
| Not Hispanic or Latino | 61 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Etanercept |
|---|---|
| American Indian or Alaska Native | 4 |
| Asian | 11 |
| Black or African American | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| White | 60 |
| Other | 3 |
| Psoriasis Area Severity Index (PASI) Score(units on a scale) | Etanercept |
|---|---|
| Mean | 16.4 ± 6.5 |
| Percent of Body Surface Area (BSA) Involved in Psoriasis(Percentage of BSA) | Etanercept |
|---|---|
| Mean | 16.4 ± 10.5 |
| Static Physician Global Assessment (sPGA) of Psoriasis(Participants) | Etanercept |
|---|---|
| 0 = Clear | 0 |
| 1 = Almost clear | 0 |
| 2 = Mild | 0 |
| 3 = Moderate | 51 |
| 4 = Severe | 28 |
| 5 = Very Severe | 1 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Ran from May 2016 to primary completion in Aug 2017, 14 months.
Results were first posted in Aug 2018, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etanercept