Plaque Psoriasis Patients
Conditions
Brief summary
With the new reimbursement criteria, we want: To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year. To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment
Detailed description
100 patients will be followed for at least 1 year
Interventions
OTHEREnbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria * Patients ≥18 year * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Weeks of Etanercept Treatment | Baseline up to end of study (90 weeks) | Average duration of time in weeks for treatment with etanercept was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Weeks of Off-Treatment | Baseline up to end of study (90 weeks) | Total duration of time in weeks for which participants discontinued etanercept treatment was reported. |
| Psoriasis Area and Severity Index (PASI) Score | Start and end of cycle 1, 2, 3 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (\<) 10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5= 70 to \<90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. |
| Percentage of Body Surface Area (BSA) Affected by Psoriasis | Start and end of cycle 1, 2, 3 | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected. |
| Number of Participants With Reasons for Treatmant Discontinuation | Baseline up to end of study (90 weeks) | Number of participants who discontinued etanercept before completing the study was reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Continuous Treatment | Baseline up to end of study (90 weeks) | Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported. |
| Number of Participants Who Received Intermittent Treatment | Baseline up to end of study (90 weeks) | Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion. | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Non-responder | 19 |
| Overall Study | Other | 6 |
| Overall Study | Participant's weight too high for dose | 1 |
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Worsening of psoriasis | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 48.83 years STANDARD_DEVIATION 12.428 |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 138 |
| serious Total, serious adverse events | 7 / 138 |
Outcome results
Primary
Number of Weeks of Etanercept Treatment
Average duration of time in weeks for treatment with etanercept was reported.
Time frame: Baseline up to end of study (90 weeks)
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Number of Weeks of Etanercept Treatment | 48.1874 weeks | Standard Deviation 17.55204 |
Secondary
Number of Participants With Reasons for Treatmant Discontinuation
Number of participants who discontinued etanercept before completing the study was reported.
Time frame: Baseline up to end of study (90 weeks)
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Non-responders | 19 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Adverse Event | 7 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Lack of Efficacy | 1 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Non-compliance | 1 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Withdrawal by Subject | 1 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Participant's weight too high for dose | 1 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Worsening of Psoriasis | 1 participants |
| Etanercept | Number of Participants With Reasons for Treatmant Discontinuation | Unspecified | 1 participants |
Secondary
Number of Weeks of Off-Treatment
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
Time frame: Baseline up to end of study (90 weeks)
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Number of Weeks of Off-Treatment | 5.5348 weeks | Standard Deviation 10.15699 |
Secondary
Percentage of Body Surface Area (BSA) Affected by Psoriasis
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Time frame: Start and end of cycle 1, 2, 3
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Start of Cycle 1 (n=129) | 14.189 percentage of BSA | Standard Deviation 14.8781 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | End of Cycle 1 (n=115) | 8.016 percentage of BSA | Standard Deviation 10.8758 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Start of Cycle 2 (n=108) | 7.579 percentage of BSA | Standard Deviation 8.8944 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | End of Cycle 2 (n=84) | 5.361 percentage of BSA | Standard Deviation 5.9864 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Start of Cycle 3 (n=78) | 5.706 percentage of BSA | Standard Deviation 6.9649 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | End of Cycle 3 (n=28) | 10.221 percentage of BSA | Standard Deviation 16.3993 |
Secondary
Psoriasis Area and Severity Index (PASI) Score
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (\<) 10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5= 70 to \<90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Time frame: Start and end of cycle 1, 2, 3
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Start of Cycle 1 (n=136) | 10.913 units on a scale | Standard Deviation 8.6412 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | End of Cycle 1 (n=123) | 6.680 units on a scale | Standard Deviation 7.6061 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Start of Cycle 2 (n=114) | 6.395 units on a scale | Standard Deviation 6.1129 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | End of Cycle 2 (n=87) | 5.571 units on a scale | Standard Deviation 6.0198 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Start of Cycle 3 (n=81) | 5.504 units on a scale | Standard Deviation 5.3579 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | End of Cycle 3 (n=25) | 5.468 units on a scale | Standard Deviation 6.281 |
Other Pre-specified
Number of Participants Who Received Continuous Treatment
Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
Time frame: Baseline up to end of study (90 weeks)
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants Who Received Continuous Treatment | 80 participants |
Other Pre-specified
Number of Participants Who Received Intermittent Treatment
Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
Time frame: Baseline up to end of study (90 weeks)
Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants Who Received Intermittent Treatment | 41 participants |