Trial Outcomes & Findings for Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients (NCT NCT02739828)
NCT ID: NCT02739828
Last Updated: 2019-08-09
Results Overview
DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
COMPLETED
24 participants
Baseline, Week 12
2019-08-09
Participant Flow
Participant milestones
| Measure |
Participants With Hidradenitis Suppurativa
Participants with moderate or severe hidradenitis suppurativa (HS) treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Participants With Hidradenitis Suppurativa
Participants with moderate or severe hidradenitis suppurativa (HS) treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Participants who were employed at Baseline and had an assessment.
Baseline characteristics by cohort
| Measure |
Participants With Hidradenitis Suppurativa
n=24 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Age, Continuous
|
39.5 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=24 Participants
|
|
Dermatology Life Quality Index (DLQI)
|
17.1 units on a scale
STANDARD_DEVIATION 7.2 • n=24 Participants
|
|
Participant's Global Assessment of Skin Pain - Numerical Rating Scale (NRS)
Skin Pain at its Worst
|
6.4 units on a scale
STANDARD_DEVIATION 2.95 • n=24 Participants
|
|
Participant's Global Assessment of Skin Pain - Numerical Rating Scale (NRS)
Skin Pain on Average
|
4.5 units on a scale
STANDARD_DEVIATION 2.83 • n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Mobility: No Problems
|
11 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Mobility: Some Problems
|
13 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Self-Care: No Problems
|
24 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Self-Care: Some Problems
|
0 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Usual Activities: No Problems
|
10 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Usual Activities: Some Problems
|
13 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Usual Activities: Unable to Do
|
1 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Pain/Discomfort: None
|
0 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Pain/Discomfort: Moderate
|
17 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Pain/Discomfort: Extreme
|
7 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Anxiety/Depression: None
|
7 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Anxiety/Depression: Moderate
|
14 Participants
n=24 Participants
|
|
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses
Anxiety/Depression: Extreme
|
3 Participants
n=24 Participants
|
|
EQ-5D Visual Analogue Scale (VAS) Score
|
56.6 units on a scale
STANDARD_DEVIATION 20.98 • n=24 Participants
|
|
Hidradenitis Suppurativa Impact Assessment (HSIA) Overall Score
|
53.9 percent of maximum HS impact
STANDARD_DEVIATION 24.1 • n=24 Participants
|
|
WPAI-SHP: Work Time Missed Due to Health Problem
|
8.5 percent of work time missed
STANDARD_DEVIATION 25.92 • n=17 Participants • Participants who were employed at Baseline and had an assessment.
|
|
WPAI-SHP: Impairment While Working Due to Health Problem
|
35 percent of impairment while working
STANDARD_DEVIATION 28.28 • n=16 Participants • Participants who were employed at Baseline and had an assessment.
|
|
WPAI-SHP: Overall Work Impairment Due to Health Problem
|
36.4 percent of overall work impairment
STANDARD_DEVIATION 29.59 • n=16 Participants • Participants who were employed at Baseline and had an assessment.
|
|
WPAI:SHP: Overall Activity Impairment Due to Health Problem
|
40.6 percent of impairment of activity
STANDARD_DEVIATION 32.3 • n=17 Participants • Participants who were employed at Baseline and had an assessment.
|
|
WPAI:SHP: Overall Activity Impairment Due to Health Problem: Participants Not Employed at Baseline
|
51.4 percent of impairment of activity
STANDARD_DEVIATION 13.45 • n=7 Participants • Participants who were not employed at Baseline and had an assessment.
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.
DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in DLQI at Week 12
|
-7.8 score on a scale
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.
DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in DLQI at Week 4
|
-9.3 score on a scale
Standard Deviation 5.94
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.
DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in DLQI at Week 24
|
-9.3 score on a scale
Standard Deviation 9.05
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.
The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4
Skin Pain at its Worst
|
-3.2 units on a scale
Standard Deviation 3.22
|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4
Skin Pain on Average
|
-2.3 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.
The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12
Skin Pain at its Worst
|
-2.9 units on a scale
Standard Deviation 2.82
|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12
Skin Pain on Average
|
-2.2 units on a scale
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.
The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24
Skin Pain at its Worst
|
-2.8 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24
Skin Pain on Average
|
-1.4 units on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.
The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
EQ-5D Questionnaire Responses at Week 4
Usual Activities: Some Problems
|
3 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Usual Activities: Unable to Perform
|
0 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Mobility: No Problems
|
17 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Mobility: Some Problems
|
2 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Self-Care: No Problems
|
18 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Self-Care: Some Problems
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Usual Activities: No Problems
|
16 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Pain/Discomfort: None
|
7 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Pain/Discomfort: Moderate
|
11 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Pain/Discomfort: Extreme
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Anxiety/Depression: None
|
9 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Anxiety/Depression: Moderate
|
10 Participants
|
|
EQ-5D Questionnaire Responses at Week 4
Anxiety/Depression: Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.
The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
EQ-5D Questionnaire Responses at Week 12
Usual Activities: Some Problems
|
2 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Mobility: No Problems
|
16 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Mobility: Some Problems
|
2 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Self-Care: No Problems
|
17 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Self-Care: Some Problems
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Usual Activities: No Problems
|
16 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Usual Activities: Unable to Perform
|
0 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Pain/Discomfort: None
|
4 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Pain/Discomfort: Moderate
|
13 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Pain/Discomfort: Extreme
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Anxiety/Depression: None
|
11 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Anxiety/Depression: Moderate
|
7 Participants
|
|
EQ-5D Questionnaire Responses at Week 12
Anxiety/Depression: Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.
The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
EQ-5D Questionnaire Responses at Week 24
Mobility: No Problems
|
14 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Mobility: Some Problems
|
4 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Self-Care: No Problems
|
17 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Self-Care: Some Problems
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Usual Activities: No Problems
|
15 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Usual Activities: Some Problems
|
2 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Usual Activities: Unable to Perform
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Pain/Discomfort: None
|
7 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Pain/Discomfort: Moderate
|
10 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Pain/Discomfort: Extreme
|
1 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Anxiety/Depression: None
|
11 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Anxiety/Depression: Moderate
|
6 Participants
|
|
EQ-5D Questionnaire Responses at Week 24
Anxiety/Depression: Severe
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in EQ-5D VAS Score at Week 4
|
9.9 score on a scale
Standard Deviation 18.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in EQ-5D VAS Score at Week 12
|
11.4 score on a scale
Standard Deviation 19.08
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in EQ-5D VAS Score at Week 24
|
8.7 score on a scale
Standard Deviation 25.52
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.
The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in HSIA Overall Score at Week 4
|
-26.7 percent of maximum HS impact
Standard Deviation 23.33
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.
The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in HSIA Overall Score at Week 12
|
-27.1 percent of maximum HS impact
Standard Deviation 20.96
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.
The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=18 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Change From Baseline in HSIA Overall Score at Week 24
|
-26 percent of maximum HS impact
Standard Deviation 24.59
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with a Week 4 assessment.
The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=13 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4
|
-6.7 percent of work time missed
Standard Deviation 28.24
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 12.
The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=10 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12
|
2 percent of work time missed
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 24.
The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=11 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24
|
-13.1 percent of work time missed
Standard Deviation 31.75
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4.
The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=12 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4
|
-17.5 percent of impairment while working
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.
The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=10 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12
|
-15 percent of impairment while working
Standard Deviation 24.61
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24.
The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=10 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24
|
-14 percent of impairment while working
Standard Deviation 16.47
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=12 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4
|
-17.4 percent of overall work impairment
Standard Deviation 28.07
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=10 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12
|
-15 percent of overall work impairment
Standard Deviation 24.61
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=10 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24
|
-16.2 percent of overall work impairment
Standard Deviation 15.85
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline at Week 4.
The 'overall activity impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall activity impairment due to health problem' was calculated based on 1 item: (Q6) to what degree did the disease impair the ability to do regular activities in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=14 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4
|
-25 percent of impairment of activity
Standard Deviation 31.32
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=13 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12
|
-16.2 percent of impairment of activity
Standard Deviation 29.59
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline assessed at Week 24.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=12 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24
|
-15 percent of impairment of activity
Standard Deviation 42.75
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 4.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=5 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline
|
-28 percent of impairment of activity
Standard Deviation 17.89
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 12.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=5 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline
|
-36 percent of impairment of activity
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 24.
The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=6 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline
|
-31.7 percent of impairment of activity
Standard Deviation 25.63
|
SECONDARY outcome
Timeframe: Week 4, 12 and 24Population: Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Observed cases with an assessment at given time point.
HiSCR is a clinical endpoint focusing on assessment of HS inflammatory signs and symptoms to determine the clinical effectiveness of adalimumab. HiSCR requires: * At least a 50% reduction in the total abscess and inflammatory nodule count (AN count) relative to baseline, and * No increase in abscess count, and * No increase in draining fistula count. In first bullet AN count is defined as sum of abscess count and inflammatory nodules count.
Outcome measures
| Measure |
Participants With Hidradenitis Suppurativa
n=19 Participants
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
|
|---|---|
|
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time
Week 24
|
61.1 percentage of participants
Interval 35.7 to 82.7
|
|
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time
Week 4
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
|
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time
Week 12
|
55.6 percentage of participants
Interval 30.8 to 78.5
|
Adverse Events
Patients With Hidradenitis Suppurativa
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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