Psoriasis
Conditions
Keywords
Phase IV, Psoriasis, Inflammation
Brief summary
The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.
Interventions
BIOLOGICALetanercept
etanercept subcutaneous injection
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older at baseline * Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5) * Able to start Enbrel (Etanercept) therapy per the approved product monograph
Exclusion criteria
* Active infections at the initiation of Enbrel therapy. * Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation. * Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period. * Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period. * Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 | Month 12 | The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 12 in Patient Global Assessment | Baseline and Month 12 | Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity. |
| Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis | Baseline and Month 12 | Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity. |
| Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score | Baseline and Month 12 | Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement. |
Participant flow
Recruitment details
Participants were enrolled from 17 March 2006 through 30 June 2008
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study. | 230 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Death | 1 |
| Overall Study | Did not receive study treatment | 16 |
| Overall Study | Disease progression | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Noncompliance | 2 |
| Overall Study | Other | 18 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol deviation | 4 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 45.5 Years STANDARD_DEVIATION 11.5 |
| Body Surface Area | 27.4 m^2 STANDARD_DEVIATION 21.3 |
| Dermatology Quality of Life Index Total Score | 13.7 Units on a scale STANDARD_DEVIATION 6.1 |
| Patient Global Assessment | 4.0 Units on a scale STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Aborigine | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 215 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 230 |
| serious Total, serious adverse events | 12 / 230 |
Outcome results
Primary
Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.
Time frame: Month 12
Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 | 166 Participants |
95% CI: [67.2, 79.1]
Secondary
Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis
Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.
Time frame: Baseline and Month 12
Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis | -69.9 Percent change |
Secondary
Percent Change From Baseline to Month 12 in Patient Global Assessment
Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.
Time frame: Baseline and Month 12
Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Percent Change From Baseline to Month 12 in Patient Global Assessment | -57.9 Percent change |
Secondary
Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score
Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.
Time frame: Baseline and Month 12
Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score | -68.2 Percent change |