Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.
Interventions
DRUGEtanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable, active plaque psoriasis * Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate
Exclusion criteria
* Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study * Systemic psoriasis therapy within 28 days prior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks | 54 weeks | Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline | 54 weeks | Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. |
| Time to Achieve a Physician Global Assessment of Psoriasis Score of Clear or Almost Clear | 54 weeks | Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included. |
| Number of Patients With Survey Response of Somewhat Satisfied or Better | 54 weeks | Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied. |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Subjects were recruited in multiple countries worldwide from to.
Pre-assignment details
Subjects were screened up to 4 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Continuous etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks | 357 |
| Intermittent etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved. | 363 |
| Total | 720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 13 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Failed to Return | 4 | 3 |
| Overall Study | Lack of Efficacy | 40 | 67 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Protocol Deviation | 6 | 3 |
| Overall Study | Protocol Violation | 5 | 4 |
| Overall Study | Withdrawal by Subject | 16 | 23 |
Baseline characteristics
| Characteristic | Intermittent | Continuous | Total |
|---|---|---|---|
| Age Continuous | 45.20 years STANDARD_DEVIATION 11.88 | 44.87 years STANDARD_DEVIATION 11.83 | 45.03 years STANDARD_DEVIATION 11.85 |
| Region of Enrollment Austria | 11 participants | 13 participants | 24 participants |
| Region of Enrollment Belgium | 21 participants | 22 participants | 43 participants |
| Region of Enrollment Czech Republic | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Denmark | 9 participants | 10 participants | 19 participants |
| Region of Enrollment Finland | 5 participants | 5 participants | 10 participants |
| Region of Enrollment France | 52 participants | 50 participants | 102 participants |
| Region of Enrollment Germany | 58 participants | 57 participants | 115 participants |
| Region of Enrollment Greece | 8 participants | 9 participants | 17 participants |
| Region of Enrollment Hungary | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Italy | 39 participants | 40 participants | 79 participants |
| Region of Enrollment Netherlands | 25 participants | 23 participants | 48 participants |
| Region of Enrollment Norway | 8 participants | 7 participants | 15 participants |
| Region of Enrollment Poland | 5 participants | 5 participants | 10 participants |
| Region of Enrollment Portugal | 6 participants | 6 participants | 12 participants |
| Region of Enrollment Spain | 19 participants | 19 participants | 38 participants |
| Region of Enrollment Sweden | 17 participants | 16 participants | 33 participants |
| Region of Enrollment Switzerland | 3 participants | 4 participants | 7 participants |
| Region of Enrollment Turkey | 11 participants | 7 participants | 18 participants |
| Region of Enrollment United Kingdom | 60 participants | 59 participants | 119 participants |
| Sex: Female, Male Female | 102 Participants | 101 Participants | 203 Participants |
| Sex: Female, Male Male | 261 Participants | 256 Participants | 517 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 281 / — | 273 / — |
| serious Total, serious adverse events | 23 / — | 31 / — |
Outcome results
Primary
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
Time frame: 54 weeks
Population: The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous | Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks | 1.98 units on scale | Standard Deviation 0.86 |
| Intermittent | Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks | 2.51 units on scale | Standard Deviation 0.65 |
p-value: <0.00195% CI: [-0.64, -0.43]ANCOVA
Secondary
Number of Patients With Survey Response of Somewhat Satisfied or Better
Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.
Time frame: 54 weeks
Population: The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous | Number of Patients With Survey Response of Somewhat Satisfied or Better | Baseline | 70 participants |
| Continuous | Number of Patients With Survey Response of Somewhat Satisfied or Better | Week 54 | 231 participants |
| Intermittent | Number of Patients With Survey Response of Somewhat Satisfied or Better | Baseline | 80 participants |
| Intermittent | Number of Patients With Survey Response of Somewhat Satisfied or Better | Week 54 | 198 participants |
p-value: 0.143Fisher Exact
Secondary
Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline
Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.
Time frame: 54 weeks
Population: The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous | Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline | 57.03 percentage improvement |
| Intermittent | Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline | 40.92 percentage improvement |
p-value: <0.001ANCOVA
Secondary
Time to Achieve a Physician Global Assessment of Psoriasis Score of Clear or Almost Clear
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.
Time frame: 54 weeks
Population: The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous | Time to Achieve a Physician Global Assessment of Psoriasis Score of Clear or Almost Clear | 127 days |
| Intermittent | Time to Achieve a Physician Global Assessment of Psoriasis Score of Clear or Almost Clear | 168 days |