Trial Outcomes & Findings for Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. (NCT NCT01421303)
NCT ID: NCT01421303
Last Updated: 2014-12-12
Results Overview
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
COMPLETED
80 participants
Baseline
2014-12-12
Participant Flow
Participant milestones
| Measure |
Etanercept
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Overall Study
STARTED
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80
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Overall Study
COMPLETED
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58
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Overall Study
NOT COMPLETED
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22
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Reasons for withdrawal
| Measure |
Etanercept
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Overall Study
Lost to Follow-up
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13
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Overall Study
Non compliance with study procedure
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1
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Overall Study
Other
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7
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
Baseline characteristics by cohort
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Age, Continuous
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38.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
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Sex: Female, Male
Female
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40 Participants
n=5 Participants
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Sex: Female, Male
Male
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40 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
Work Time Missed (n=67)
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30.18 Percentage of impairment
Standard Deviation 40.64
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
Impairment While Working (n=55)
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49.09 Percentage of impairment
Standard Deviation 22.87
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
Overall work impairment (n=49)
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53.06 Percentage of impairment
Standard Deviation 25.67
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
Activity impairment (n=79)
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63.29 Percentage of impairment
Standard Deviation 21.47
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PRIMARY outcome
Timeframe: Month 6Population: Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
Work Time Missed (n=61)
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6.23 Percentage of impairment
Standard Deviation 22.55
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
Impairment While Working (n=59)
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27.97 Percentage of impairment
Standard Deviation 22.42
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
Overall work impairment (n=56)
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28.07 Percentage of impairment
Standard Deviation 23.45
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
Activity impairment (n=72)
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31.81 Percentage of impairment
Standard Deviation 24.57
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PRIMARY outcome
Timeframe: Month 12Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
Work Time Missed (n=55)
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5.52 Percentage of impairment
Standard Deviation 22.91
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
Impairment While Working (n=56)
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25.18 Percentage of impairment
Standard Deviation 22.40
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
Overall work impairment (n=51)
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23.97 Percentage of impairment
Standard Deviation 21.75
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
Activity impairment (n=67)
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29.55 Percentage of impairment
Standard Deviation 26.02
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PRIMARY outcome
Timeframe: Month 18Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18
Work Time Missed (n=46)
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1.06 Percentage of impairment
Standard Deviation 7.17
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18
Impairment While Working (n=45)
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24.89 Percentage of impairment
Standard Deviation 20.96
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18
Overall work impairment (n=44)
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24.65 Percentage of impairment
Standard Deviation 21.69
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18
Activity impairment (n=55)
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30.18 Percentage of impairment
Standard Deviation 24.30
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PRIMARY outcome
Timeframe: Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.
WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
|
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24
Work Time Missed (n=41)
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6.31 Percentage of impairment
Standard Deviation 22.36
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24
Impairment While Working (n=41)
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24.88 Percentage of impairment
Standard Deviation 20.39
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24
Overall work impairment (n=38)
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25.88 Percentage of impairment
Standard Deviation 21.86
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Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24
Activity impairment (n=56)
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30.18 Percentage of impairment
Standard Deviation 23.55
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SECONDARY outcome
Timeframe: Baseline, Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI: AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
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|---|---|
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 24: Activity impairment (n=56)
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-33.75 Percentage of impairment
Standard Deviation 25.05
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 6: Work Time Missed (n=55)
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-22.61 Percentage of impairment
Standard Deviation 40.36
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 6: Impairment While Working (n=44)
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-22.05 Percentage of impairment
Standard Deviation 24.55
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 6: Overall work impairment (n=38)
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-24.68 Percentage of impairment
Standard Deviation 27.70
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 6: Activity impairment (n=72)
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-31.53 Percentage of impairment
Standard Deviation 26.41
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 24: Work Time Missed (n=36)
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-27.11 Percentage of impairment
Standard Deviation 45.41
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 24: Impairment While Working (n=27)
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-29.63 Percentage of impairment
Standard Deviation 19.71
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Month 24: Overall work impairment (n=23)
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-33.44 Percentage of impairment
Standard Deviation 22.83
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SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline
Work Time Missed and BASDAI (n=66)
|
0.21 Correlation coefficient
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline
Impairment While Working and BASDAI (n=55)
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0.60 Correlation coefficient
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline
Overall work impairment and BASDAI (n=49)
|
0.62 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline
Activity impairment and BASDAI (n=78)
|
0.62 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 6: Work Time Missed and BASDAI (n=55)
|
0.23 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 6: Impairment While Working and BASDAI(n=44)
|
0.62 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 6: Overall work impairment and BASDAI(n= 38)
|
0.56 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 6: Activity impairment and BASDAI (n=72)
|
0.55 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 24: Work Time Missed and BASDAI (n=36)
|
0.41 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 24:Impairment While Working and BASDAI(n=27)
|
0.42 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 24:Overall work impairment and BASDAI(n= 23)
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0.40 Correlation coefficient
|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24
Month 24: Activity impairment and BASDAI (n=56)
|
0.63 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline
Work Time Missed and BASFI (n=67)
|
0.29 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline
Impairment While Working and BASFI (n=55)
|
0.59 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline
Overall work impairment and BASFI (n= 49)
|
0.58 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline
Activity impairment and BASFI (n=79)
|
0.54 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 6: Work Time Missed and BASFI (n=55)
|
0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 6:Impairment While Working and BASFI(n=44)
|
0.56 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 6: Overall work impairment and BASFI(n=38)
|
0.62 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 6: Activity impairment and BASFI (n=71)
|
0.62 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 24: Work Time Missed and BASFI (n=36)
|
0.37 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 24:Impairment While Working and BASFI(n=27)
|
0.47 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 24: Overall work impairment and BASFI(n=23)
|
0.43 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24
Month 24: Activity impairment and BASFI (n=56)
|
0.57 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant's limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline
Work Time Missed and BASMI (n=65)
|
0.06 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline
Impairment While Working and BASMI (n=53)
|
0.30 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline
Overall work impairment and BASMI (n= 47)
|
0.23 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline
Activity impairment and BASMI (n=77)
|
0.08 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant's limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 6: Work Time Missed and BASMI (n=50)
|
0.17 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 6: Impairment While Working and BASMI(n=41)
|
0.26 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 6: Overall work impairment and BASMI (n=35)
|
0.12 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 6: Activity impairment and BASMI (n=66)
|
0.31 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 24: Work Time Missed and BASMI (n=33)
|
-0.088 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 24: Impairment While Working and BASMI(n=24)
|
0.34 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 24: Overall work impairment and BASMI(n=20)
|
0.39 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Month 24: Activity impairment and BASMI (n=53)
|
-0.070 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline
Work Time Missed and BAS-G (n=67)
|
0.21 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline
Impairment While Working and BAS-G (n=55)
|
0.48 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline
Overall work impairment and BAS-G (n=49)
|
0.48 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline
Activity impairment and BAS-G (n=79)
|
0.61 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 6: Work Time Missed and BAS-G (n=55)
|
0.34 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 6: Impairment While Working and BAS-G (n=44)
|
0.56 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 6: Overall work impairment and BAS-G (n=38)
|
0.55 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 6: Activity impairment and BAS-G (n=72)
|
0.64 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 24: Work Time Missed and BAS-G (n=36)
|
0.25 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 24: Impairment While Working and BAS-G(n=27)
|
0.28 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 24: Overall work impairment and BAS-G (n=23)
|
0.26 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Month 24: Activity impairment and BAS-G (n=56)
|
0.60 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with \<50=lower level of functioning and \>50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline
Work Time Missed and PCS (n=66)
|
-0.52 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline
Impairment While Working and PCS (n=54)
|
-0.52 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline
Overall work impairment and PCS (n=48)
|
-0.57 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline
Activity impairment and PCS (n=77)
|
-0.43 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with \<50=lower level of functioning and \>50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 6: Work Time Missed and PCS (n=51)
|
-0.41 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 6:Impairment While Working and PCS (n=41)
|
-0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 6: Overall work impairment and PCS(n=35)
|
-0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 6: Activity impairment and PCS(n=66)
|
-0.57 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 24: Work Time Missed and PCS(n=28)
|
-0.52 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 24: Impairment While Working and PCS(n= 22)
|
-0.25 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 24: Overall work impairment and PCS(n= 18)
|
-0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Month 24: Activity impairment and PCS (n=45)
|
-0.60 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with \<50=lower level of functioning and \>50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline
Activity impairment and MCS (n=77)
|
-0.51 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline
Work Time Missed and MCS (n=66)
|
-0.06 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline
Impairment While Working and MCS (n=54)
|
-0.38 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline
Overall work impairment and MCS (n=48)
|
-0.41 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with \<50=lower level of functioning and \>50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 6: Work Time Missed and MCS (n=51)
|
-0.19 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 6: Impairment While Working and MCS(n=41)
|
-0.33 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 6: Overall work impairment and MCS(n=35)
|
-0.45 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 6: Activity impairment and MCS(n=66)
|
-0.29 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 24: Work Time Missed and MCS(n=28)
|
0.038 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 24: Impairment While Working and MCS(n= 22)
|
-0.006 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 24: Overall work impairment and MCS(n= 18)
|
0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Month 24: Activity impairment and MCS(n=45)
|
-0.39 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state \[no problems\], 3=worst health state \[confined to bed\]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline
Work Time Missed and EQ-5D (n=66)
|
-0.17 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline
Impairment While Working and EQ-5D (n=54)
|
-0.58 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline
Overall work impairment and EQ-5D (n=48)
|
-0.59 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline
Activity impairment and EQ-5D (n=78)
|
-0.52 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state \[no problems\], 3=worst health state \[confined to bed\]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
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Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 6: Work Time Missed and EQ-5D (n=55)
|
-0.19 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 6: Impairment While Working and EQ-5D(n=44)
|
-0.60 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 6: Overall work impairment and EQ-5D(n=38)
|
-0.59 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 6: Activity impairment and EQ-5D(n=72)
|
-0.33 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 24: Work Time Missed and EQ-5D(n=34)
|
0.007 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 24: Impairment While Working and EQ-5D(n=26)
|
-0.33 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 24: Overall work impairment and EQ-5D(n= 22)
|
-0.20 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Month 24: Activity impairment and EQ-5D(n=54)
|
-0.43 Correlation coefficient
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.
Outcome measures
| Measure |
Etanercept
n=80 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline
Work Time Missed and EQ-5D VAS (n=64)
|
-0.06 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline
Impairment While Working and EQ-5D VAS (n=54)
|
-0.42 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline
Overall work impairment and EQ-5D VAS (n=47)
|
-0.47 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline
Activity impairment and EQ-5D VAS (n=75)
|
-0.59 Correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6, Month 24Population: FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.
Outcome measures
| Measure |
Etanercept
n=75 Participants
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
|
|---|---|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 6: Work Time Missed, EQ-5D VAS (n=53)
|
-0.15 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 6: Impairment While Working, EQ-5D VAS(n=44)
|
-0.57 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 6: Overall work impairment, EQ-5D VAS(n=38)
|
-0.62 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 6: Activity impairment, EQ-5D VAS (n=70)
|
-0.54 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 24: Work Time Missed, EQ-5D VAS (n=34)
|
0.009 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 24:Impairment While Working, EQ-5D VAS(n=26)
|
-0.32 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 24: Overall work impairment, EQ-5D VAS(n=23)
|
-0.36 Correlation coefficient
|
|
Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Month 24: Activity impairment, EQ-5D VAS (n=53)
|
-0.52 Correlation coefficient
|
Adverse Events
Etanercept
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER