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

Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients With Moderate or Severe Hidradenitis Suppurativa (HS) After 6 Months on Adalimumab Treatment (HOPE Study)

The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Biological: Adalimumab

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Sweden
  • Halmstad, Sweden, 301 85
    • Hallands Hospital Halmstad
  • Karlskrona, Sweden, SE-37185
    • Blekinge Hospital
  • Skovde, Sweden, 541 85
    • Skaraborgs Hospital
  • Solna, Sweden, 17176
    • Karolinska Univ Sjukhuset
  • Stockholm, Sweden, 11883
    • Södersjukhuset
  • Stockholm, Sweden, 182 88
    • Danderyd Hospital
  • Stockholm, Sweden, 112 51
    • Kungsholmens Hudklinik
  • Trelleborg, Sweden, 231 85
    • Trelleborg Hospital
  • Umeå, Sweden, 90185
    • Norrlands universitetssjukhus
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset
  • Vastra Gotalands Lan
    • Linkoping, Vastra Gotalands Lan, Sweden, 581 85
      • Universitetssjukhuset Linköping

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with moderate or severe Hidradenitis Suppurativa

Description

Inclusion Criteria:

• Diagnosis of Hidradenitis Suppurativa
• Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
• Willingness to sign and date a Patient Information/Informed Consent Form

Exclusion Criteria:

• Prior biologic treatment discontinued <6 months before the baseline visit
• Patient not able to understand the language of the provided patient questionnaires
• History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Hidradenitis Suppurativa; Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.	Biological: Adalimumab; Adalimumab; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DLQI 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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DLQI 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.	Baseline, Week 4
Change From Baseline in DLQI 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.	Baseline, Week 24
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS 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.	Baseline, Week 4
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS 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.	Baseline, Week 12
Change From Baseline in Participant's Global Assessment of Skin Pain - NRS 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.	Baseline, Week 24
EQ-5D Questionnaire Responses 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."	Baseline, Week 4
EQ-5D Questionnaire Responses 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."	Baseline, Week 12
EQ-5D Questionnaire Responses 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."	Baseline, Week 24
Change From Baseline in EQ-5D VAS Score 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.	Baseline, Week 4
Change From Baseline in EQ-5D VAS Score 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.	Baseline, Week 12
Change From Baseline in EQ-5D VAS Score 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.	Baseline, Week 24
Change From Baseline in HSIA Overall Score 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).	Baseline, Week 4
Change From Baseline in HSIA Overall Score 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).	Baseline, Week 12
Change From Baseline in HSIA Overall Score 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).	Baseline, Week 24
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4	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.	Baseline, Week 4
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem 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.	Baseline, Week 12
WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem 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.	Baseline, Week 24
WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem 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.	Baseline, Week 4
Mean Change From Baseline in Impairment While Working Due to Health Problem 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.	Baseline, Week 12
Mean Change From Baseline in Impairment While Working Due to Health Problem 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.	Baseline, Week 24
Mean Change From Baseline in Overall Work Impairment Due to Health Problem 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.	Baseline, Week 4
Mean Change From Baseline in Overall Work Impairment Due to Health Problem 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.	Baseline, Week 12
Mean Change From Baseline in Overall Work Impairment Due to Health Problem 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.	Baseline, Week 24
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem 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.	Baseline, Week 4
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem 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.	Baseline, Week 12
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem 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.	Baseline, Week 24
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline	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.	Baseline, Week 4
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline	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.	Baseline, Week 12
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline	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.	Baseline, Week 24
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time	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.	Week 4, 12 and 24

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2016
• Primary Completion (ACTUAL): March 28, 2018
• Study Completion (ACTUAL): March 28, 2018

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: P15-692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No