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Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients (HOPE)

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ClinicalTrials.gov Identifier: NCT02739828
Recruitment Status : Completed
First Posted : April 15, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hidradenitis Suppurativa
Intervention Biological: Adalimumab
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 24
Completed 19
Not Completed 5
Reason Not Completed
Adverse Event             1
Lost to Follow-up             4
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
39.5
(21 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
17
  70.8%
Male
7
  29.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 24 participants
23
  95.8%
Mixed Race Number Analyzed 24 participants
1
   4.2%
Dermatology Life Quality Index (DLQI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 24 participants
17.1  (7.2)
[1]
Measure Description: 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.
Participant's Global Assessment of Skin Pain - Numerical Rating Scale (NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Skin Pain at its Worst Number Analyzed 24 participants
6.4  (2.95)
Skin Pain on Average Number Analyzed 24 participants
4.5  (2.83)
[1]
Measure Description: 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 visual analogue scale (VAS) response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.
EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Mobility: No Problems Number Analyzed 24 participants
11
  45.8%
Mobility: Some Problems Number Analyzed 24 participants
13
  54.2%
Self-Care: No Problems Number Analyzed 24 participants
24
 100.0%
Self-Care: Some Problems Number Analyzed 24 participants
0
   0.0%
Usual Activities: No Problems Number Analyzed 24 participants
10
  41.7%
Usual Activities: Some Problems Number Analyzed 24 participants
13
  54.2%
Usual Activities: Unable to Do Number Analyzed 24 participants
1
   4.2%
Pain/Discomfort: None Number Analyzed 24 participants
0
   0.0%
Pain/Discomfort: Moderate Number Analyzed 24 participants
17
  70.8%
Pain/Discomfort: Extreme Number Analyzed 24 participants
7
  29.2%
Anxiety/Depression: None Number Analyzed 24 participants
7
  29.2%
Anxiety/Depression: Moderate Number Analyzed 24 participants
14
  58.3%
Anxiety/Depression: Extreme Number Analyzed 24 participants
3
  12.5%
[1]
Measure Description: 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."
EQ-5D Visual Analogue Scale (VAS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 24 participants
56.6  (20.98)
[1]
Measure Description: The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better health-related quality of life (HRQL). 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Increased scores correspond to better health state.
Hidradenitis Suppurativa Impact Assessment (HSIA) Overall Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of maximum HS impact
Number Analyzed 24 participants
53.9  (24.1)
[1]
Measure Description: 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).
WPAI-SHP: Work Time Missed Due to Health Problem   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent of work time missed
Number Analyzed 17 participants
8.5  (25.92)
[1]
Measure Description: The Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) questionnaire is a 6-item questionnaire used to assess work and activity impairment due to symptoms of HS. Work time missed is 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, using the formula Q2/(Q2+Q4) and converted to percent. Higher numbers indicate greater impairment and less productivity.
[2]
Measure Analysis Population Description: Participants who were employed at Baseline and had an assessment.
WPAI-SHP: Impairment While Working Due to Health Problem   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent of impairment while working
Number Analyzed 16 participants
35  (28.28)
[1]
Measure Description: WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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), using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
[2]
Measure Analysis Population Description: Participants who were employed at Baseline and had an assessment.
WPAI-SHP: Overall Work Impairment Due to Health Problem   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent of overall work impairment
Number Analyzed 16 participants
36.4  (29.59)
[1]
Measure Description: WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. Calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days; (Q4) the number of actual work hours in the past 7 days; and (Q5) to what degree did the disease impair the productivity while working past 7 days, 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.
[2]
Measure Analysis Population Description: Participants who were employed at Baseline and had an assessment.
WPAI:SHP: Overall Activity Impairment Due to Health Problem   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent of impairment of activity
Number Analyzed 17 participants
40.6  (32.3)
[1]
Measure Description: WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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, measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working), using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
[2]
Measure Analysis Population Description: Participants who were employed at Baseline and had an assessment.
WPAI:SHP: Overall Activity Impairment Due to Health Problem: Participants Not Employed at Baseline   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent of impairment of activity
Number Analyzed 7 participants
51.4  (13.45)
[1]
Measure Description: WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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, measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working), using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
[2]
Measure Analysis Population Description: Participants who were not employed at Baseline and had an assessment.
1.Primary Outcome
Title Change From Baseline in DLQI at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.8  (6.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in DLQI at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
-9.3  (5.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in DLQI at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
-9.3  (9.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Skin Pain at its Worst -3.2  (3.22)
Skin Pain on Average -2.3  (2.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Skin Pain at its Worst -2.9  (2.82)
Skin Pain on Average -2.2  (2.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Skin Pain at its Worst -2.8  (2.66)
Skin Pain on Average -1.4  (2.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0094
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
7.Secondary Outcome
Title EQ-5D Questionnaire Responses at Week 4
Hide Description 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."
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Mobility: No Problems
17
  89.5%
Mobility: Some Problems
2
  10.5%
Self-Care: No Problems
18
  94.7%
Self-Care: Some Problems
1
   5.3%
Usual Activities: No Problems
16
  84.2%
Usual Activities: Some Problems
3
  15.8%
Usual Activities: Unable to Perform
0
   0.0%
Pain/Discomfort: None
7
  36.8%
Pain/Discomfort: Moderate
11
  57.9%
Pain/Discomfort: Extreme
1
   5.3%
Anxiety/Depression: None
9
  47.4%
Anxiety/Depression: Moderate
10
  52.6%
Anxiety/Depression: Severe
0
   0.0%
8.Secondary Outcome
Title EQ-5D Questionnaire Responses at Week 12
Hide Description 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."
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Mobility: No Problems
16
  88.9%
Mobility: Some Problems
2
  11.1%
Self-Care: No Problems
17
  94.4%
Self-Care: Some Problems
1
   5.6%
Usual Activities: No Problems
16
  88.9%
Usual Activities: Some Problems
2
  11.1%
Usual Activities: Unable to Perform
0
   0.0%
Pain/Discomfort: None
4
  22.2%
Pain/Discomfort: Moderate
13
  72.2%
Pain/Discomfort: Extreme
1
   5.6%
Anxiety/Depression: None
11
  61.1%
Anxiety/Depression: Moderate
7
  38.9%
Anxiety/Depression: Severe
0
   0.0%
9.Secondary Outcome
Title EQ-5D Questionnaire Responses at Week 24
Hide Description 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."
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Mobility: No Problems
14
  77.8%
Mobility: Some Problems
4
  22.2%
Self-Care: No Problems
17
  94.4%
Self-Care: Some Problems
1
   5.6%
Usual Activities: No Problems
15
  83.3%
Usual Activities: Some Problems
2
  11.1%
Usual Activities: Unable to Perform
1
   5.6%
Pain/Discomfort: None
7
  38.9%
Pain/Discomfort: Moderate
10
  55.6%
Pain/Discomfort: Extreme
1
   5.6%
Anxiety/Depression: None
11
  61.1%
Anxiety/Depression: Moderate
6
  33.3%
Anxiety/Depression: Severe
1
   5.6%
10.Secondary Outcome
Title Change From Baseline in EQ-5D VAS Score at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.9  (18.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0278
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in EQ-5D VAS Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.4  (19.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in EQ-5D VAS Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.7  (25.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1652
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in HSIA Overall Score at Week 4
Hide Description 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).
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: percent of maximum HS impact
-26.7  (23.33)
14.Secondary Outcome
Title Change From Baseline in HSIA Overall Score at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent of maximum HS impact
-27.1  (20.96)
15.Secondary Outcome
Title Change From Baseline in HSIA Overall Score at Week 24
Hide Description 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).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent of maximum HS impact
-26  (24.59)
16.Secondary Outcome
Title WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percent of work time missed
-6.7  (28.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
17.Secondary Outcome
Title WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of work time missed
2  (6.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
18.Secondary Outcome
Title WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent of work time missed
-13.1  (31.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
19.Secondary Outcome
Title WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent of impairment while working
-17.5  (28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1797
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
20.Secondary Outcome
Title Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of impairment while working
-15  (24.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4531
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
21.Secondary Outcome
Title Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of impairment while working
-14  (16.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0313
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
22.Secondary Outcome
Title Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent of overall work impairment
-17.4  (28.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3438
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
23.Secondary Outcome
Title Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of overall work impairment
-15  (24.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4531
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
24.Secondary Outcome
Title Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of overall work impairment
-16.2  (15.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0156
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
25.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-25  (31.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0386
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
26.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-16.2  (29.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3438
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
27.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-15  (42.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
28.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-28  (17.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
29.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-36  (8.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
30.Secondary Outcome
Title Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants With Hidradenitis Suppurativa
Hide Arm/Group Description:
Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percent of impairment of activity
-31.7  (25.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Hidradenitis Suppurativa
Comments Analysis is under the assumption of completely missing at random (deleted incomplete observations).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
31.Secondary Outcome
Title Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time
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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.
Time Frame Week 4, 12 and 24
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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.
Arm/Group Title Participants With Hidradenitis Suppurativa
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Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4 Number Analyzed 19 participants
73.7
(48.8 to 90.9)
Week 12 Number Analyzed 18 participants
55.6
(30.8 to 78.5)
Week 24 Number Analyzed 18 participants
61.1
(35.7 to 82.7)
Time Frame Up to 24 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Hidradenitis Suppurativa
Hide Arm/Group Description Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
All-Cause Mortality
Patients With Hidradenitis Suppurativa
Affected / at Risk (%)
Total   0/24 (0.00%) 
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Patients With Hidradenitis Suppurativa
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients With Hidradenitis Suppurativa
Affected / at Risk (%)
Total   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02739828     History of Changes
Other Study ID Numbers: P15-692
First Submitted: April 12, 2016
First Posted: April 15, 2016
Results First Submitted: March 21, 2019
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019