Ankylosing Spondylitis
Conditions
Brief summary
Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.
Detailed description
Purely descriptive
Interventions
Enbrel
Sponsors
Study design
Eligibility
Inclusion criteria
* Active AS patients (as judged by the treating MD) who are currently employed. * Patients who are scheduled by their rheumatologist to initiate treatment with Etanercept.
Exclusion criteria
* Patients who initiated a procedure for eligibility of work disability/pension. * Patients with previous use of TNF-alpha inhibitors either in commercial use, or in a study for the treatment of AS or a related spondylarthropathy condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline | 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. |
| Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 | 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. |
| Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12 | 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. |
| Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18 | 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. |
| Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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, Month 24 | 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. |
| Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline | 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. |
| 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, Month 24 | 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. |
| 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 | 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. |
| 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, Month 24 | 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. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24 | Baseline, Month 6, 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 (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. |
| 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, Month 24 | 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. |
| 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 | 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. |
| 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, Month 24 | 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. |
| 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 | 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. |
| 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, Month 24 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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, Month 24 | 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. |
| 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 | 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. |
| 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, Month 24 | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Non compliance with study procedure | 1 |
| Overall Study | Other | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | โ / โ |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores 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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline | Work Time Missed (n=67) | 30.18 Percentage of impairment | Standard Deviation 40.64 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline | Impairment While Working (n=55) | 49.09 Percentage of impairment | Standard Deviation 22.87 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline | Overall work impairment (n=49) | 53.06 Percentage of impairment | Standard Deviation 25.67 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline | Activity impairment (n=79) | 63.29 Percentage of impairment | Standard Deviation 21.47 |
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores 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.
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12 | Work Time Missed (n=55) | 5.52 Percentage of impairment | Standard Deviation 22.91 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12 | Impairment While Working (n=56) | 25.18 Percentage of impairment | Standard Deviation 22.4 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12 | Overall work impairment (n=51) | 23.97 Percentage of impairment | Standard Deviation 21.75 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12 | Activity impairment (n=67) | 29.55 Percentage of impairment | Standard Deviation 26.02 |
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores 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.
Time frame: Month 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18 | Work Time Missed (n=46) | 1.06 Percentage of impairment | Standard Deviation 7.17 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18 | Impairment While Working (n=45) | 24.89 Percentage of impairment | Standard Deviation 20.96 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18 | Overall work impairment (n=44) | 24.65 Percentage of impairment | Standard Deviation 21.69 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18 | Activity impairment (n=55) | 30.18 Percentage of impairment | Standard Deviation 24.3 |
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores 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.
Time frame: Month 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24 | Work Time Missed (n=41) | 6.31 Percentage of impairment | Standard Deviation 22.36 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24 | Impairment While Working (n=41) | 24.88 Percentage of impairment | Standard Deviation 20.39 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24 | Overall work impairment (n=38) | 25.88 Percentage of impairment | Standard Deviation 21.86 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24 | Activity impairment (n=56) | 30.18 Percentage of impairment | Standard Deviation 23.55 |
Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores 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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 | Work Time Missed (n=61) | 6.23 Percentage of impairment | Standard Deviation 22.55 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 | Impairment While Working (n=59) | 27.97 Percentage of impairment | Standard Deviation 22.42 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 | Overall work impairment (n=56) | 28.07 Percentage of impairment | Standard Deviation 23.45 |
| Etanercept | Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 | Activity impairment (n=72) | 31.81 Percentage of impairment | Standard Deviation 24.57 |
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 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 (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.
Time frame: Baseline, Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | 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) | -29.63 Percentage of impairment | Standard Deviation 19.71 |
| Etanercept | 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) | -22.61 Percentage of impairment | Standard Deviation 40.36 |
| Etanercept | 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) | -22.05 Percentage of impairment | Standard Deviation 24.55 |
| Etanercept | 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) | -24.68 Percentage of impairment | Standard Deviation 27.7 |
| Etanercept | 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) | -31.53 Percentage of impairment | Standard Deviation 26.41 |
| Etanercept | 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) | -27.11 Percentage of impairment | Standard Deviation 45.41 |
| Etanercept | 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) | -33.44 Percentage of impairment | Standard Deviation 22.83 |
| Etanercept | 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) | -33.75 Percentage of impairment | Standard Deviation 25.05 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 Month 6 and 24
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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) | 0.60 Correlation coefficient |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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) | 0.40 Correlation coefficient |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 Global Score (BAS-G) 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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
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
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.
Time frame: Month 6, Month 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |
| Etanercept | 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 |