Psoriatic Arthritis
Conditions
Keywords
Psoriatic Arthritis, PsA, Commercial product, American College of Rheumatology, ACR/PASI
Brief summary
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
Interventions
DRUGEtanercept
Administered according to the product monograph by subcutaneous (SC) injection
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care * At least one of the following forms of psoriatic arthritis (PsA): * Distal interphalangeal (DIP) involvement (inflammatory) * Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis * Arthritis mutilans * Asymmetric peripheral arthritis or * Spinal involvement * Active psoriatic arthritis at the time of the study enrollment * Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints * Greater than 18 years of age at the time of consent * Able to start etanercept therapy per the approved product monograph * Informed consent must be provided before any study specific procedures are performed
Exclusion criteria
* Active infections at time of initiating Enbrel® therapy * Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication * A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years * Known hypersensitivity to etanercept or any of its components * Patients receiving, or who have received: * Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or * Kineret® (anakinra) in the previous 15 days * Patients receiving or who have received etanercept * Treatment with any investigational therapy in the 30 days prior to enrollment or during the study * Active guttate, erythrodermic or pustular psoriasis at the time of screening * Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph * Sepsis or at risk of septic syndrome * Patients not available for follow-up assessment * Concerns for subject's compliance with the protocol procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI | Baseline and 24 months | The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module | Baseline and 24 months | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
| Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module | Baseline and Month 24 | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
| Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module | Baseline and month 24 | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
| Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module | Baseline and month 24 | In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
| Change From Baseline to Month 24 in the Physician Global Assessment | Baseline and month 24 | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. |
| Percent Change From Baseline to Month 24 in Physician Global Assessment | Baseline and Month 24 | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement. |
| Change From Baseline to Month 24 in Patient Global Assessment | Baseline and Month 24 | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. |
| Percent Change From Baseline to Month 24 in Patient Global Assessment | Baseline and month 24 | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement. |
| Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI) | Baseline and Month 24 | The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis. |
| Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24 | Baseline and Month 24 | Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor). |
Participant flow
Recruitment details
Participants were enrolled from 5 August 2005 through 2 February 2007
Participants by arm
| Arm | Count |
|---|---|
| Enbrel Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Noncompliance | 2 |
| Overall Study | Other | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Enbrel |
|---|---|
| Age, Continuous | 48.4 Years STANDARD_DEVIATION 10.9 |
| Health and Labour Questionnaire (HLQ) Absence from Work Module | 0.8 days STANDARD_DEVIATION 2.51 |
| HLQ Impediments to Work Module | 3.0 Units on a scale STANDARD_DEVIATION 1.33 |
| HLQ Reduced Productivity at Paid Work Module | 2.3 Hours STANDARD_DEVIATION 8.22 |
| HLQ Unpaid Work Module: Help Received with Unpaid Work Paid help | 2.2 Hours STANDARD_DEVIATION 9.2 |
| HLQ Unpaid Work Module: Help Received with Unpaid Work Unpaid help | 7.7 Hours STANDARD_DEVIATION 10.2 |
| Patient Global Assessment | 3.28 Units on a scale STANDARD_DEVIATION 0.559 |
| Physician Global Assessment | 3.23 Units on a scale STANDARD_DEVIATION 0.463 |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Canadian Aboriginal | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 103 Participants |
| Race/Ethnicity, Customized Chinese | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Other Asian | 2 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 67 / 110 |
| serious Total, serious adverse events | 14 / 110 |
Outcome results
Primary
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
Time frame: Baseline and 24 months
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enbrel | Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI | 56.0 percentage of participants |
Secondary
Change From Baseline to Month 24 in Patient Global Assessment
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
Time frame: Baseline and Month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in Patient Global Assessment | 0.59 Units on a scale | Standard Deviation 0.874 |
Secondary
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Time frame: Baseline and 24 months
Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module | 0.4 days | Standard Deviation 2.64 |
Secondary
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Time frame: Baseline and month 24
Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module | 1.5 Units on a scale | Standard Deviation 1.68 |
Secondary
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Time frame: Baseline and Month 24
Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module | 0.0 Hours | Standard Deviation 0 |
Secondary
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Time frame: Baseline and month 24
Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). n indicates the number of participants who had unpaid or paid help with their unpaid work.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module | Unpaid help (n=66) | 3.2 Hours | Standard Deviation 12.06 |
| Enbrel | Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module | Paid help (n=27) | 1.9 Hours | Standard Deviation 11.39 |
Secondary
Change From Baseline to Month 24 in the Physician Global Assessment
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
Time frame: Baseline and month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enbrel | Change From Baseline to Month 24 in the Physician Global Assessment | 0.91 Units on a scale | Standard Deviation 0.991 |
Secondary
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).
Time frame: Baseline and Month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enbrel | Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24 | 78.9 percentage of participants |
Secondary
Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)
The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.
Time frame: Baseline and Month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enbrel | Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI) | 41.8 percentage of participants |
Secondary
Percent Change From Baseline to Month 24 in Patient Global Assessment
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement.
Time frame: Baseline and month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enbrel | Percent Change From Baseline to Month 24 in Patient Global Assessment | 16.4 Percentage change |
Secondary
Percent Change From Baseline to Month 24 in Physician Global Assessment
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement.
Time frame: Baseline and Month 24
Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enbrel | Percent Change From Baseline to Month 24 in Physician Global Assessment | 27.2 Percentage change |