Trial Outcomes & Findings for Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium (NCT NCT01845818)
NCT ID: NCT01845818
Last Updated: 2019-01-09
Results Overview
The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.
COMPLETED
183 participants
Baseline, Month 18
2019-01-09
Participant Flow
Participant milestones
| Measure |
Ankylosing Spondylitis
Participants with ankylosing spondylitis and in whom adalimumab treatment is initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis and in whom adalimumab treatment is initiated.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
57
|
|
Overall Study
COMPLETED
|
81
|
40
|
|
Overall Study
NOT COMPLETED
|
45
|
17
|
Reasons for withdrawal
| Measure |
Ankylosing Spondylitis
Participants with ankylosing spondylitis and in whom adalimumab treatment is initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis and in whom adalimumab treatment is initiated.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Administrative Reasons
|
3
|
1
|
|
Overall Study
Serious Adverse Event
|
1
|
1
|
|
Overall Study
Other
|
25
|
8
|
|
Overall Study
Did Not Receive Any Dose of Adalimumab
|
5
|
0
|
|
Overall Study
No Follow-Up Data Available
|
4
|
1
|
Baseline Characteristics
Participants with a questionnaire completed at baseline are included.
Baseline characteristics by cohort
| Measure |
Ankylosing Spondylitis
n=117 Participants
Participants with ankylosing spondylitis and in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=56 Participants
Participants with psoriatic arthritis and in whom adalimumab treatment was initiated.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.74 years
STANDARD_DEVIATION 9.55 • n=117 Participants
|
43.32 years
STANDARD_DEVIATION 8.39 • n=56 Participants
|
39.54 years
STANDARD_DEVIATION 9.53 • n=173 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=117 Participants
|
28 Participants
n=56 Participants
|
87 Participants
n=173 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=117 Participants
|
28 Participants
n=56 Participants
|
86 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
114 Participants
n=117 Participants
|
55 Participants
n=56 Participants
|
169 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Other (Not Specified)
|
2 Participants
n=117 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=117 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=173 Participants
|
|
Total Work Productivity Impairment (TWPI)
|
57.09 percentage of TWPI
STANDARD_DEVIATION 27.47 • n=64 Participants • Participants with a questionnaire completed at baseline are included.
|
47.54 percentage of TWPI
STANDARD_DEVIATION 31.86 • n=33 Participants • Participants with a questionnaire completed at baseline are included.
|
53.84 percentage of TWPI
STANDARD_DEVIATION 29.23 • n=97 Participants • Participants with a questionnaire completed at baseline are included.
|
PRIMARY outcome
Timeframe: Baseline, Month 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.
The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=56 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)
|
-29.15 percentage of TWPI
Standard Deviation 35.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.
The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=39 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=17 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)
|
-30.47 percentage of TWPI
Standard Deviation 34.88
|
-26.11 percentage of TWPI
Standard Deviation 37.39
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=112 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=55 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=167 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Number of Participants Employed at Each Assessed Visit
Last Observation : All
|
108 Participants
|
55 Participants
|
163 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 18 : No
|
12 Participants
|
8 Participants
|
20 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 18 : Yes
|
59 Participants
|
31 Participants
|
90 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 18 : All
|
71 Participants
|
39 Participants
|
110 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Last Observation : No
|
21 Participants
|
13 Participants
|
34 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Last Observation : Yes
|
87 Participants
|
42 Participants
|
129 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Baseline : No
|
26 Participants
|
14 Participants
|
40 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Baseline : Yes
|
86 Participants
|
41 Participants
|
127 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Baseline : All
|
112 Participants
|
55 Participants
|
167 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 3 : No
|
21 Participants
|
10 Participants
|
31 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 3 : Yes
|
78 Participants
|
38 Participants
|
116 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 3 : All
|
99 Participants
|
48 Participants
|
147 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 6 : No
|
17 Participants
|
10 Participants
|
27 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 6 : Yes
|
70 Participants
|
34 Participants
|
104 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 6 : All
|
87 Participants
|
44 Participants
|
131 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 12 : No
|
14 Participants
|
8 Participants
|
22 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 12 : Yes
|
67 Participants
|
30 Participants
|
97 Participants
|
|
Number of Participants Employed at Each Assessed Visit
Month 12 : All
|
81 Participants
|
38 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.
Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=76 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=35 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=110 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Month 6
|
6.79 percentage of work time missed
Standard Deviation 21.45
|
5.82 percentage of work time missed
Standard Deviation 19.58
|
6.45 percentage of work time missed
Standard Deviation 20.72
|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Baseline
|
24.29 percentage of work time missed
Standard Deviation 40.09
|
12.27 percentage of work time missed
Standard Deviation 27.76
|
20.39 percentage of work time missed
Standard Deviation 36.86
|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Month 3
|
10.24 percentage of work time missed
Standard Deviation 29.53
|
5.39 percentage of work time missed
Standard Deviation 19.56
|
8.57 percentage of work time missed
Standard Deviation 26.53
|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Month 12
|
5.90 percentage of work time missed
Standard Deviation 21.00
|
2.27 percentage of work time missed
Standard Deviation 10.66
|
4.94 percentage of work time missed
Standard Deviation 18.83
|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Month 18
|
12.19 percentage of work time missed
Standard Deviation 31.34
|
2.00 percentage of work time missed
Standard Deviation 10.00
|
8.97 percentage of work time missed
Standard Deviation 26.85
|
|
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
Last Observation
|
12.94 percentage of work time missed
Standard Deviation 31.71
|
4.41 percentage of work time missed
Standard Deviation 18.94
|
10.31 percentage of work time missed
Standard Deviation 28.57
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.
Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=111 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=55 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=163 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Month 18
|
28.59 percentage activity impairment
Standard Deviation 27.89
|
25.13 percentage activity impairment
Standard Deviation 28.46
|
27.36 percentage activity impairment
Standard Deviation 28.01
|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Baseline
|
62.25 percentage activity impairment
Standard Deviation 22.75
|
57.25 percentage activity impairment
Standard Deviation 26.01
|
60.68 percentage activity impairment
Standard Deviation 23.86
|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Month 3
|
39.59 percentage activity impairment
Standard Deviation 28.68
|
32.22 percentage activity impairment
Standard Deviation 27.21
|
37.27 percentage activity impairment
Standard Deviation 28.34
|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Month 6
|
31.61 percentage activity impairment
Standard Deviation 26.05
|
33.72 percentage activity impairment
Standard Deviation 27.95
|
32.31 percentage activity impairment
Standard Deviation 26.60
|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Month 12
|
31.33 percentage activity impairment
Standard Deviation 26.22
|
30.00 percentage activity impairment
Standard Deviation 29.50
|
30.91 percentage activity impairment
Standard Deviation 27.17
|
|
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
Last Observation
|
34.17 percentage activity impairment
Standard Deviation 28.75
|
32.73 percentage activity impairment
Standard Deviation 29.22
|
33.68 percentage activity impairment
Standard Deviation 28.82
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.
As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=75 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=36 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=111 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Baseline
|
55.45 percentage impairment while working
Standard Deviation 25.91
|
46.18 percentage impairment while working
Standard Deviation 30.35
|
52.30 percentage impairment while working
Standard Deviation 27.70
|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Month 3
|
24.44 percentage impairment while working
Standard Deviation 24.48
|
26.18 percentage impairment while working
Standard Deviation 27.53
|
25.05 percentage impairment while working
Standard Deviation 25.46
|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Month 6
|
22.67 percentage impairment while working
Standard Deviation 19.30
|
28.75 percentage impairment while working
Standard Deviation 29.04
|
24.78 percentage impairment while working
Standard Deviation 23.18
|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Month 12
|
25.17 percentage impairment while working
Standard Deviation 24.11
|
15.65 percentage impairment while working
Standard Deviation 20.41
|
22.53 percentage impairment while working
Standard Deviation 23.42
|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Month 18
|
25.00 percentage impairment while working
Standard Deviation 27.97
|
19.29 percentage impairment while working
Standard Deviation 25.81
|
23.00 percentage impairment while working
Standard Deviation 27.21
|
|
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
Last Observation
|
28.93 percentage impairment while working
Standard Deviation 29.25
|
26.39 percentage impairment while working
Standard Deviation 28.40
|
28.11 percentage impairment while working
Standard Deviation 28.87
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=55 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Baseline
|
1.34 units on a scale
Standard Deviation 0.58
|
—
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Month 3
|
0.70 units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Month 6
|
0.70 units on a scale
Standard Deviation 0.61
|
—
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Month 12
|
0.62 units on a scale
Standard Deviation 0.65
|
—
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Month 18
|
0.54 units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
Last Observation
|
0.68 units on a scale
Standard Deviation 0.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=55 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Baseline
|
5.85 units on a scale
Standard Deviation 7.25
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Month 3
|
3.11 units on a scale
Standard Deviation 5.72
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Month 6
|
3.29 units on a scale
Standard Deviation 6.93
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Month 12
|
2.30 units on a scale
Standard Deviation 4.81
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Month 18
|
2.08 units on a scale
Standard Deviation 4.84
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
Last Observation
|
3.24 units on a scale
Standard Deviation 6.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \[without any difficulty\] to 3 \[unable to do\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=114 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Baseline
|
1.21 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Month 3
|
0.76 units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Month 6
|
0.59 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Month 12
|
0.60 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Month 18
|
0.61 units on a scale
Standard Deviation 0.53
|
—
|
—
|
|
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
Last Observation
|
0.68 units on a scale
Standard Deviation 0.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score \> 5.1 indicates high disease activity, a DAS-28 score \< 3.2 indicates low disease activity, and a DAS-28 score \< 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=33 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Baseline
|
4.37 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Month 3
|
2.26 units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Month 6
|
2.17 units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Month 12
|
1.99 units on a scale
Standard Deviation 1.06
|
—
|
—
|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Month 18
|
1.99 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
Last Observation
|
2.05 units on a scale
Standard Deviation 1.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a BSA assessment at given time point are included.
Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=56 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Baseline: 0%
|
34.5 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Baseline: < 3%
|
32.7 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Baseline: 3% to 10%
|
27.3 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Baseline: 11% to 20%
|
5.5 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Baseline: > 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 3: 0%
|
52.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 3: < 3%
|
36.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 3: 3% to 10%
|
8.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 3: 11% to 20%
|
2.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 3: > 20%
|
2.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 6: 0%
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 6: < 3%
|
36.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 6: 3% to 10%
|
8.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 6: 11% to 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 6: > 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 12: 0%
|
59.1 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 12: < 3%
|
36.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 12: 3% to 10%
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 12: 11% to 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 12: > 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 18: 0%
|
63.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 18: < 3%
|
31.7 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 18: 3% to 10%
|
2.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 18: 11% to 20%
|
2.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Month 18: > 20%
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Last Observation: 0%
|
60.7 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Last Observation: < 3%
|
30.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Last Observation: 3% to 10%
|
5.4 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Last Observation: 11% to 20%
|
1.8 percentage of participants
|
—
|
—
|
|
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
Last Observation: > 20%
|
1.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.
The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=116 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Baseline
|
6.85 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Month 3
|
3.97 units on a scale
Standard Deviation 2.27
|
—
|
—
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Month 6
|
3.18 units on a scale
Standard Deviation 2.01
|
—
|
—
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Month 12
|
3.27 units on a scale
Standard Deviation 2.37
|
—
|
—
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Month 18
|
3.09 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
Last Observation
|
3.76 units on a scale
Standard Deviation 2.50
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.
The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=80 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=47 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=126 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Baseline
|
15.14 mm/h
Standard Deviation 14.74
|
12.77 mm/h
Standard Deviation 12.05
|
14.25 mm/h
Standard Deviation 13.80
|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Month 3
|
8.23 mm/h
Standard Deviation 8.13
|
6.05 mm/h
Standard Deviation 5.17
|
7.41 mm/h
Standard Deviation 7.21
|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Month 6
|
7.65 mm/h
Standard Deviation 7.15
|
10.83 mm/h
Standard Deviation 13.62
|
8.78 mm/h
Standard Deviation 10.00
|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Month 12
|
7.38 mm/h
Standard Deviation 8.54
|
10.03 mm/h
Standard Deviation 11.86
|
8.47 mm/h
Standard Deviation 10.05
|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Month 18
|
7.63 mm/h
Standard Deviation 6.84
|
7.17 mm/h
Standard Deviation 5.98
|
7.46 mm/h
Standard Deviation 6.50
|
|
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
Last Observation
|
8.19 mm/h
Standard Deviation 6.93
|
10.84 mm/h
Standard Deviation 12.49
|
9.14 mm/h
Standard Deviation 9.36
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.
CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=108 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=51 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=159 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Baseline
|
2.36 mg/dL
Standard Deviation 7.16
|
1.48 mg/dL
Standard Deviation 3.06
|
2.08 mg/dL
Standard Deviation 6.15
|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Month 3
|
0.35 mg/dL
Standard Deviation 0.45
|
0.81 mg/dL
Standard Deviation 1.95
|
0.51 mg/dL
Standard Deviation 1.23
|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Month 6
|
0.62 mg/dL
Standard Deviation 1.18
|
0.82 mg/dL
Standard Deviation 2.08
|
0.69 mg/dL
Standard Deviation 1.54
|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Month 12
|
0.39 mg/dL
Standard Deviation 0.50
|
0.66 mg/dL
Standard Deviation 1.66
|
0.49 mg/dL
Standard Deviation 1.11
|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Month 18
|
0.50 mg/dL
Standard Deviation 0.76
|
0.36 mg/dL
Standard Deviation 0.55
|
0.45 mg/dL
Standard Deviation 0.69
|
|
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
Last Observation
|
0.52 mg/dL
Standard Deviation 0.90
|
0.91 mg/dL
Standard Deviation 2.04
|
0.65 mg/dL
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.
The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=107 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=55 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=162 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Baseline
|
67.14 mm
Standard Deviation 16.03
|
59.35 mm
Standard Deviation 15.65
|
64.58 mm
Standard Deviation 16.28
|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 3
|
24.92 mm
Standard Deviation 20.51
|
21.19 mm
Standard Deviation 17.23
|
23.62 mm
Standard Deviation 19.45
|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 6
|
18.40 mm
Standard Deviation 17.57
|
19.34 mm
Standard Deviation 16.08
|
18.73 mm
Standard Deviation 17.01
|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 12
|
18.13 mm
Standard Deviation 17.76
|
17.12 mm
Standard Deviation 15.54
|
17.79 mm
Standard Deviation 17.00
|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 18
|
17.39 mm
Standard Deviation 18.03
|
15.07 mm
Standard Deviation 17.91
|
16.57 mm
Standard Deviation 17.95
|
|
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Last Observation
|
21.70 mm
Standard Deviation 21.00
|
18.31 mm
Standard Deviation 18.36
|
20.55 mm
Standard Deviation 20.15
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.
The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=113 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=55 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=168 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Baseline
|
67.53 mm
Standard Deviation 20.14
|
60.89 mm
Standard Deviation 19.91
|
65.36 mm
Standard Deviation 20.25
|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 3
|
36.31 mm
Standard Deviation 26.97
|
30.42 mm
Standard Deviation 25.58
|
34.35 mm
Standard Deviation 26.58
|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 6
|
25.80 mm
Standard Deviation 23.58
|
34.46 mm
Standard Deviation 28.63
|
28.73 mm
Standard Deviation 25.63
|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 12
|
28.89 mm
Standard Deviation 26.48
|
29.00 mm
Standard Deviation 27.39
|
28.93 mm
Standard Deviation 26.66
|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Month 18
|
24.86 mm
Standard Deviation 24.30
|
24.55 mm
Standard Deviation 25.30
|
24.75 mm
Standard Deviation 24.55
|
|
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
Last Observation
|
31.31 mm
Standard Deviation 26.95
|
32.64 mm
Standard Deviation 28.18
|
31.75 mm
Standard Deviation 27.29
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 12, 18Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.
The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain).
Outcome measures
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=113 Participants
Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.
|
Psoriatic Arthritis
n=55 Participants
Participants with psoriatic arthritis in whom adalimumab treatment was initiated.
|
Ankylosing Spondylitis and Psoriatic Arthritis
n=168 Participants
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|---|---|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Baseline
|
70.17 mm
Standard Deviation 18.59
|
64.24 mm
Standard Deviation 19.02
|
68.23 mm
Standard Deviation 18.88
|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Month 3
|
37.91 mm
Standard Deviation 27.63
|
29.60 mm
Standard Deviation 25.97
|
35.14 mm
Standard Deviation 27.28
|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Month 6
|
27.73 mm
Standard Deviation 24.49
|
34.93 mm
Standard Deviation 30.51
|
30.17 mm
Standard Deviation 26.78
|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Month 12
|
29.55 mm
Standard Deviation 26.80
|
30.79 mm
Standard Deviation 29.73
|
29.94 mm
Standard Deviation 27.64
|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Month 18
|
27.41 mm
Standard Deviation 25.84
|
25.68 mm
Standard Deviation 27.69
|
26.78 mm
Standard Deviation 26.41
|
|
Participant's Global Assessment of Pain VAS Scores Over Time
Last Observation
|
33.35 mm
Standard Deviation 27.92
|
33.93 mm
Standard Deviation 30.69
|
33.55 mm
Standard Deviation 28.79
|
Adverse Events
Ankylosing Spondylitis and Psoriatic Arthritis
Serious adverse events
| Measure |
Ankylosing Spondylitis and Psoriatic Arthritis
n=173 participants at risk
Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
|
Infections and infestations
Appendicitis
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
|
Infections and infestations
Herpes zoster
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
|
Renal and urinary disorders
Calculus bladder
|
0.58%
1/173 • Number of events 1 • Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).
Adverse events were analyzed for all participants as one group, per protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER